AM\1348819EN.docx PE791.891v01-00
EN United in diversity EN
European Parliament
2024-2029
Committee on Public Health
2025/0404(COD)
28.7.2026
AMENDMENTS
616 - 857
Draft report
Oliver Schenk
(PE787.987v01-00)
Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards
simplifying and reducing the burden of the rules on medical devices and in
vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as
regards the support of the European Medicines Agency for the expert panels on
medical devices and Regulation (EU) 2024/1689 as regards the list of Union
harmonisation legislation referred to in its Annex I
Proposal for a regulation
(COM(2025)1023 – 2025/0404(COD))
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AM_Com_LegReport
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Amendment 616
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 1 – paragraph 1 – point 86
Regulation (EU) 2017/745
Article 106 – paragraph 7
Text proposed by the Commission Amendment
7. In addition to the tasks assigned to
them in other provisions of this Regulation
and of Regulation (EU) 2017/746, the
expert panels may have the following
tasks:
7. In addition to the tasks assigned to
them in other provisions of this Regulation
and of Regulation (EU) 2017/746, the
expert panels shall support the MDCG
and the Commission in the following
tasks:
Or. en
Justification
Expert panels should provide scientific, clinical and technical advice — regulatory authority
stays with Member States via the MDCG ('support', not independent tasks). Adding patient
representatives with disease-area experience as full members increases legitimacy and real-
world relevance, following the EMA model.
Amendment 617
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 1 – paragraph 1 – point 86
Regulation (EU) 2017/745
Article 106 – paragraph 7 – point a
Text proposed by the Commission Amendment
(a) to provide scientific, clinical,
technical and regulatory advice to the
Commission, the MDCG, Member States
or notified bodies in relation to the
implementation of this Regulation or
Regulation (EU) 2017/746;
(a) to provide scientific, clinical,
technical advice in relation to the
implementation of this Regulation or
Regulation (EU) 2017/746;
Or. en
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Amendment 618
Kateřina Konečná
Proposal for a regulation
Article 1 – paragraph 1 – point 86
Regulation (EU) 2017/745
Article 106 – paragraph 8 a (new)
Text proposed by the Commission Amendment
8a. Persons with lived experience
contributing to the work of expert panels
pursuant to paragraphs 4 or 5 shall be
remunerated on terms equivalent to those
applicable to other experts, and shall have
access to the training, documentation and
support necessary to participate
effectively.
Or. en
Amendment 619
Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo
Proposal for a regulation
Article 1 – paragraph 1 – point 87
Regulation (EU) 2017/745
Article 106b – paragraph 1
Text proposed by the Commission Amendment
1. The EMA shall, on behalf of the
Commission, provide scientific, technical
and administrative support to the national
competent authorities designated under this
Regulation and under Regulation (EU)
2017/746 to facilitate the exchange of
experience, cooperation and coordination
with a view to ensuring a uniform
application of such Regulations, in
particular in the following areas:
1. The EMA shall, on behalf of the
Commission, provide administrative
support to the national competent
authorities designated under this
Regulation and under Regulation (EU)
2017/746 to facilitate the exchange of
experience, cooperation and coordination
with a view to ensuring a uniform
application of such Regulations, in
particular in the following areas:
Or. en
Amendment 620
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Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 1 – paragraph 1 – point 87
Regulation (EU) 2017/745
Article 106b – paragraph 1
Text proposed by the Commission Amendment
1. The EMA shall, on behalf of the
Commission, provide scientific, technical
and administrative support to the national
competent authorities designated under this
Regulation and under Regulation (EU)
2017/746 to facilitate the exchange of
experience, cooperation and coordination
with a view to ensuring a uniform
application of such Regulations, in
particular in the following areas:
1. The EMA shall, on behalf of the
Commission, provide administrative
support to the national competent
authorities designated under this
Regulation and under Regulation (EU)
2017/746 to facilitate the exchange of
experience, cooperation and coordination
with a view to ensuring a uniform
application of such Regulations, in
particular in the following areas:
Or. it
Justification
Article 106b expands the EMA’s role in product qualification, despite the MDCG being
strengthened and a new expert panel established, increasing procedural complexity. As its
mandate mainly covers medicinal products, in borderline cases related to non-
pharmacological devices, the EMA should only provide technical administrative support,
without decision-making powers, to protect regulatory certainty, innovation and
competitiveness.
Amendment 621
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 1 – paragraph 1 – point 87
Regulation (EU) 2017/745
Article 106a – paragraph 1 – point a
Text proposed by the Commission Amendment
(a) regulatory status of products and
classification of devices in accordance
with Articles 4, 4a, 51, 51a and 51b of this
Regulation and Articles 3, 3a, 47, 47a and
47b of Regulation (EU) 2017/746;
deleted
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Or. it
Amendment 622
Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo
Proposal for a regulation
Article 1 – paragraph 1 – point 87
Regulation (EU) 2017/745
Article 106a – paragraph 1 – point a
Text proposed by the Commission Amendment
(a) regulatory status of products and
classification of devices in accordance
with Articles 4, 4a, 51, 51a and 51b of this
Regulation and Articles 3, 3a, 47, 47a and
47b of Regulation (EU) 2017/746;
deleted
Or. en
Amendment 623
Kristoffer Storm
Proposal for a regulation
Article 1 – paragraph 1 – point 87
Regulation (EU) 2017/746
Article 106b – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
(da) devices which incorporate, as an
integral part, a substance which, if used
separately, would be considered to be a
medicinal product as defined in point 2 of
Article 1 of Directive 2001/83/EC, as
referred to in Article 1(8) and Article 1(9)
of this Regulation, including coordination
with notified bodies, national competent
authorities and, where appropriate,
EMA’s Combination Products
Operational Group, to ensure consistent
application across the Union of the
relevant general safety and performance
requirements set out in Annex I to this
Regulation in respect of the device part of
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such product, and to facilitate the
exchange of scientific and regulatory
expertise throughout the lifecycle of such
products.
Or. en
Amendment 624
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 1 – paragraph 1 – point 87
Regulation (EU) 2017/745
Article 106b – paragraph 1 – point da (new )
Text proposed by the Commission Amendment
1a. devices which incorporate, as an
integral part, a substance which, if used
separately, would be considered to be a
medicinal product as defined in point 2 of
Article 1 of Directive 2001/83/EC, as
referred to in Article 1(8) and Article 1(9)
of this Regulation, including coordination
with notified bodies, national competent
authorities and, where appropriate,
EMA’s Combination Products
Operational Group, to ensure consistent
application across the Union of the
relevant general safety and performance
requirements set out in Annex I to this
Regulation in respect of the device part of
such product, and to facilitate the
exchange of scientific and regulatory
expertise throughout the lifecycle of such
products.
Or. en
Justification
Art. 117 duplicates requirements now contained in the General Pharmaceutical Legislation
— the same obligation in two laws creates ambiguity and dual compliance burden. Deleting it
removes the duplication (the requirement remains in the GPL). The new Art. 106b(1)(e) gives
EMA explicit coordination via its COMBO group: one-door entry, consistent application of
the GSPRs, and shorter, more predictable reviews. Around 20% of EMA marketing
authorisation applications involve combination products.
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Amendment 625
Laurence Trochu
Proposal for a regulation
Article 1 – paragraph 1 – point 90
Regulation (EU) 2017/745
Article 108a – paragraph 4
Text proposed by the Commission Amendment
The Commission may sign administrative
arrangements with authorities of third
countries and with international
organisations for the purpose of regulatory
cooperation in the field of medical devices
and in vitro diagnostic medical devices,
including:
With the agreement of the Council of the
EU, the Commission may sign
administrative arrangements with
authorities of third countries and with
international organisations for the purpose
of regulatory cooperation in the field of
medical devices and in vitro diagnostic
medical devices, including:
Or. fr
Justification
The administrative arrangements signed by the Commission on international cooperation
could be legally binding for the Member States. They should, therefore, be involved in the
decision, in accordance with the principle of mutual sincere cooperation and Article 13 TEU.
Amendment 626
Michele Picaro, Ruggero Razza
Proposal for a regulation
Article 1 – paragraph 1 – point 90 a (new)
Regulation (EU) 2017/745
Article 110
Text proposed by the Commission Amendment
(90a) Article 110 is deleted;
Or. en
Amendment 627
Michele Picaro, Ruggero Razza
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Proposal for a regulation
Article 1 – paragraph 1 – point 90 b (new)
Regulation (EU) 2017/745
Article 110a (new)
Text proposed by the Commission Amendment
(90b) the following Article 110a is
inserted:
Article 110a
Processing of personal data in the
activities governed by this Regulation
1. The processing of personal data,
including health data and genetic data, in
compliance with the obligations of this
Regulation shall be carried out pursuant
to Article 6(1)(c) of Regulation (EU)
2016/679. For special categories of
personal data it shall be carried out
pursuant to Article 9(2)(j) of that
Regulation, with the safeguards under
Article 89(1), for the purposes referred to
in paragraph 2, point (a), and pursuant to
Article 9(2)(i) for the remaining purposes
referred to in paragraph 2, in so far as
necessary to ensure high standards of
quality and safety of medical devices and
in vitro diagnostic medical devices.
2. Processing shall be carried out, to the
extent necessary, for the following
purposes:
a) the conduct and management of [the
clinical investigations / the performance
studies], including authorization,
monitoring, the recording and reporting
of serious adverse events and device
deficiencies, the submission of the report
and the archiving of the master file;
b) post-market surveillance, including
post-market clinical follow-up, post-
market performance follow-up and the
reports provided for by this Regulation;
c) vigilance, including the recording,
reporting and management of serious
incidents and field safety corrective
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actions, and trend reporting;
d) the cybersecurity of connected devices,
including the reporting of actively
exploited vulnerabilities and serious
cybersecurity incidents;
e) the identification and traceability of
devices and economic operators, and the
populating of Eudamed and of the other
electronic systems provided by this
Regulation.
The categories of personal data and of
data subjects shall be specified, for [the
clinical investigations / the performance
studies], in the authorized protocol and,
for the remaining purposes, in the
planning and management documents
provided for by this Regulation.
3. Personal data shall be stored for the
period required by the relevant provisions
of this Regulation. The data collected
pursuant to paragraph 2 may be further
processed by the same controller,
pursuant to Article 6(1)(e) of Regulation
(EU) 2016/679 and in compliance with
the basis under Article 9(2) referred to in
paragraph 1, for other [clinical
investigations / performance studies], for
post-market clinical follow-up and post-
market performance follow-up, and for
research aimed at ensuring high
standards of quality, safety and
performance of devices, subject to
pseudonymization, the establishment of
appropriate governance structures,
confidentiality obligations of staff and
information of the data subjects.
4. Controllers shall implement
appropriate and specific measures to
safeguard the rights and freedoms of data
subjects pursuant to Articles 5, 24, 25, 32
and — where relevant — 89 of
Regulation (EU) 2016/679, including, in
particular:
a) the pseudonymization of personal data
and the adoption of technical and
organizational measures suitable to
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ensure their integrity, confidentiality and
controlled access, including
confidentiality obligations of staff; the
processing of directly identifiable data
shall be permitted only where necessary to
achieve the purpose pursued;
b) the transmission of personal data to the
competent authorities of the Member
States, to the Commission and to the
notified bodies solely to the extent
necessary for the performance of their
respective tasks, as a rule in
pseudonymized form;
c) the identification, in the planning and
management documents referred to in
paragraph 2, of the further specific
technical and organizational measures.
5. By way of derogation from Article 9(4)
of Regulation (EU) 2016/679, Member
States may not maintain or introduce,
with regard to the processing of personal
data, including health data and genetic
data, carried out pursuant to this Article,
further conditions, including limitations
and specific provisions.;
Or. en
Amendment 628
Tiemo Wölken
Proposal for a regulation
Article 1 – paragraph 1 – point 94
Regulation (EU) 2017/745
Article 116
Text proposed by the Commission Amendment
(94) Article 116 is deleted; deleted
Or. en
Amendment 629
Kristoffer Storm
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Proposal for a regulation
Article 1 – paragraph 1 – point 94 a (new)
Regulation (EU) 2017/745
Article 117
Present text Amendment
(94a) Article 117 is deleted
Article 117 ""
Amendment to Directive 2001/83/EC
InAnnex I to Directive 2001/83/EC, point
12 of Section 3.2. is replaced by the
following:‘
(12)Where, in accordance with the second
subparagraph of Article 1(8) or the
second subparagraph of Article 1(9) of
Regulation (EU) 2017/745 of the
European Parliament and of the Council
(*1), a product is governed by this
Directive, the marketing authorisation
dossier shall include, where available, the
results of the assessment of the
conformity of the device part with the
relevant general safety and performance
requirements set out in Annex I to that
Regulation contained in the
manufacturer's EU declaration of
conformity or the relevant certificate
issued by a notified body allowing the
manufacturer to affix a CE marking to
the medical device.
Or. en
(Regulation (EU) 2017/745)
Amendment 630
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 1 – paragraph 1 – point 94 a (new)
Regulation (EU) 2017/745
Article 117
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Present text Amendment
(94 a) Article 117 is deleted
Amendment to Directive 2001/83/EC ""
In Annex I to Directive 2001/83/EC, point
12 of Section 3.2. is replaced by the
following: ‘(12) Where, in accordance
with the second subparagraph of Article
1(8) or the second subparagraph of
Article 1(9) of Regulation (EU) 2017/745
of the European Parliament and of the
Council (*), a product is governed by this
Directive, the marketing authorisation
dossier shall include, where available, the
results of the assessment of the
conformity of the device part with the
relevant general safety and performance
requirements set out in Annex I to that
Regulation contained in the
manufacturer's EU declaration of
conformity or the relevant certificate
issued by a notified body allowing the
manufacturer to affix a CE marking to
the medical device.
Or. en
(Regulation (EU) 2017/745)
Amendment 631
Tiemo Wölken
Proposal for a regulation
Article 1 – paragraph 1 – point 96
Regulation (EU) 2017/745
Article 121 – paragraphs 1a (new), 1b (new) and 1c (new)
Text proposed by the Commission Amendment
2. The evaluation shall, in particular,
assess:
(a) whether the simplification measures
introduced by this Regulation have had
any unintended consequences affecting
the safety or performance of medical
devices, the effectiveness of market
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surveillance, vigilance or post-market
surveillance activities, or the overall level
of protection of public health.
(b) the effectiveness of the measures
introduced to simplify the regulatory
framework and reduce the administrative
burden on manufacturers, notified bodies
and competent authorities, including their
impact on regulatory efficiency, legal
certainty and the timely availability of
medical devices on the Union market;
(c) the impact of the reduction or
adaptation of notified body fees and other
measures intended to improve access to
conformity assessment, including their
effect on the capacity, availability and
geographical distribution of notified
bodies, particularly for micro, small and
medium-sized enterprises;
(d) the functioning and effectiveness of
the regulatory sandboxes established
under this Regulation, including their
contribution to innovation, regulatory
learning, regulatory convergence and the
development of guidance, common
specifications, implementing acts or
legislative proposals;
(e) the effectiveness of the framework for
well-established technologies, including
its impact on regulatory efficiency,
innovation, patient access, post-market
safety and whether the eligibility criteria
remain appropriate in light of scientific
and technological developments;
(f) the application of the accelerated
conformity assessment pathway for
orphan devices and breakthrough devices,
including its impact on timely patient
access, innovation, the generation of
clinical evidence, post-market clinical
follow-up, patient safety and the
availability of such devices across the
Union;
(g) the impact of the revised classification
rules for software and the simplified
approach to low-risk software
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modifications on innovation, regulatory
burden, cybersecurity, patient safety and
the performance of software-based
medical devices, including software
incorporating artificial intelligence where
applicable;
(h) the impact of the measures
strengthening stakeholder involvement,
including the participation of patients,
healthcare professionals and their
representative organisations in the work
of the MDCG, expert panels, vigilance
activities and Eudamed, and their
contribution to the transparency, quality
and legitimacy of regulatory decision-
making;
(i) the functioning of Eudamed, including
its contribution to transparency,
traceability, coordination between
Member States, access to information for
patients, healthcare professionals and the
public, and the effectiveness of its publicly
accessible modules; (k) the effectiveness
of the measures introduced to improve the
availability of medical devices and to
prevent or mitigate shortages, including
their impact on the continuity of supply of
critical medical devices within the Union;
(j) the impact of the measures introduced
to facilitate structured scientific, technical
and regulatory dialogue between
manufacturers and notified bodies on the
efficiency, predictability and quality of
conformity assessment procedures, while
preserving the independence, objectivity
and impartiality of notified bodies;
(k) whether the measures introduced by
this Regulation have maintained an
appropriate balance between facilitating
innovation and market access and
ensuring the generation of sufficient
clinical evidence throughout the lifecycle
of medical devices, including through
post-market clinical follow-up and post-
market surveillance.
3. The evaluation shall be based, inter
alia, on information provided by Member
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States, competent authorities, the Medical
Device Coordination Group, expert
panels, notified bodies, manufacturers,
healthcare professionals, patient
organisations and other relevant
stakeholders, as well as data available
through the EUDAMED.
4. The Commission shall make the
findings of the evaluation publicly
available. Where appropriate, the
Commission shall accompany the report
with legislative proposals to amend this
Regulation.
Or. en
Amendment 632
Laurence Trochu
Proposal for a regulation
Article 1 – paragraph 1 – point 96
Regulation (EU) 2017/745
Article 121 – paragraph 1
Text proposed by the Commission Amendment
No sooner than … [Publications Office,
please insert the date five years after the
date of application of this Regulation], the
Commission shall carry out an evaluation
of this Regulation and present a report on
the main findings to the European
Parliament and the Council.
No sooner than … [Publications Office,
please insert the date three years after the
date of application of this Regulation], the
Commission shall carry out an evaluation
of this Regulation and present a report on
the main findings to the European
Parliament and the Council. As part of this
evaluation, the Commission shall carry
out an in-depth impact assessment of
brain-machine interfaces, especially those
incorporating artificial intelligence, in
order to evaluate, in particular, the ethical
dimension, the risk of harm to mental
integrity and cognitive liberty, and the
therapeutic prospects. It shall forward its
report to the European Parliament and
the Council, indicating the conditions
under which such devices could be
marketed.
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Or. fr
Amendment 633
Tiemo Wölken
Proposal for a regulation
Article 1 – paragraph 1 – point 96
Regulation (EU) 2017/745
Article 121 – paragraph 1
Text proposed by the Commission Amendment
No sooner than …[Publications Office,
please insert the date five years after the
date of application of this Regulation], the
Commission shall carry out an evaluation
of this Regulation and present a report on
the main findings to the European
Parliament and the Council.
No later than... [Publications Office,
please insert the date five years after the
date of application of the Amendment],
and every 10 years thereafter, the
Commission shall carry out an evaluation
of this Regulation and present a report on
the main findings to the European
Parliament and the Council. The
evaluation shall assess whether the
measures introduced by this Regulation
have achieved their objectives while
maintaining the high level of protection of
health and safety of patients, users and
other persons provided for by this
Regulation.
Or. en
Amendment 634
Tiemo Wölken
Proposal for a regulation
Article 1 – paragraph 1 – point 96
Regulation (EU) 2017/745
Article 121 – paragraph 2
Text proposed by the Commission Amendment
Member States and notified bodies shall
provide the Commission with the
information necessary for the preparation
of that report.
Member States,notified bodies and, where
needed, relevant stakeholders including
patient and consumer organisations,
healthcare professionals and
manufacturers, shall provide the
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Commission with the information
necessary for the preparation of that report.
Or. en
Amendment 635
Adam Jarubas
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point d
Regulation (EU) 2017/746
Article 2 – point 78a (new)
Text proposed by the Commission Amendment
(78a) ‘connected device’ means an
active device which intended purpose or
reasonably foreseeable use of which
includes a direct or indirect logical or
physical data connection to a device or
network, based on the definitions: ‘logical
connection’, ‘physical connection’ and
‘indirect connection’ included in article 3
of Regulation (EU) 2024/2847 of the
European Parliament and of the Council.
Or. en
Amendment 636
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point d a (new)
Regulation (EU) 2017/746
Article 2 – point 78a (new)
Text proposed by the Commission Amendment
(da) the following point is added:
‘Breakthrough device’ means a
breakthrough device as defined in
Regulation 2017/745 (consolidated).
Or. en
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Amendment 637
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point d b (new)
Regulation (EU) 2017/746
Article 2 – point 78b (new)
Text proposed by the Commission Amendment
(db) the following point is added:
‘Orphan device’ means an orphan device
as defined in Regulation 2017/745
(consolidated)
Or. en
Amendment 638
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 2 – point d c (new)
Regulation (EU) 2017/746
Article 2 – point 78c (new)
Text proposed by the Commission Amendment
(dc) the following point is added:
‘Paediatric device’ means a paediatric
device as defined in Regulation 2017/745
(consolidated)
Or. en
Amendment 639
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Regulation (EU) 2017/746
Article 3 – paragraph 1
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Text proposed by the Commission Amendment
1. The competent authorities of the
Member States shall coordinate their
activities when determining whether a
specific product, or category or group of
products, falls within the definition of an
‘in vitro diagnostic medical device’ or of
an ‘accessory for an in vitro diagnostic
medical device’.
1. The competent authorities of the
Member States shall coordinate their
activities when determining whether a
specific product that has already been
placed on the market falls within the
definition of an ‘in vitro diagnostic medical
device’ or of an ‘accessory for an in vitro
diagnostic medical device’.
Or. it
Justification
In line with the case law of the Court of Justice of the European Union, the regulatory status
of a product must be assessed on a case-by-case basis. The reference to categories or groups
of products should therefore be deleted.
Amendment 640
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Regulation (EU) 2017/746
Article 3 – paragraph 3
Text proposed by the Commission Amendment
3. Where a competent authority of a
Member State, after having performed an
evaluation in accordance with Article 89,
considers that a product that is CE marked
in accordance with Article 18, does not fall
within the scope of this Regulation, it shall
consult the competent authorities of the
other Member States regarding its
envisaged measure determining the
regulatory status of the product in question.
3. Where a competent authority of a
Member State, after having performed an
evaluation in accordance with Article 89
and taking account of the provisions of
paragraph 5a, has substantial evidence
that a product that is CE marked in
accordance with Article 18, does not fall
within the scope of this Regulation, it shall
consult the competent authorities of the
other Member States regarding its
envisaged measure determining the
regulatory status of the product in question.
Or. it
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Justification
It is essential that, before questioning the regulatory status of a device already placed on the
market, the competent authority has documented evidence to support its doubts as to the
qualification of the device.
Amendment 641
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Regulation (EU) 2017/746
Article 3 – paragraph 5a (new)
Text proposed by the Commission Amendment
5a. For products bearing the CE
marking and for which the conformity
assessment referred to in Article 48
involved a notified body, the procedure set
out in this Article shall only apply where
the competent authority concerned has
substantiated evidence that the regulatory
status of the product as an in vitro
diagnostic medical device poses an
unacceptable risk within the meaning of
Article 89(a). The regulatory status of the
product does not in itself constitute such
proof.
Or. it
Justification
To provide legal certainty to the medical devices and IVD industry and to reaffirm the value
of the EC certificate as proof of conformity, the regulatory status of a product already on the
market should only be reassessed under clearly defined conditions and where there is an
unacceptable risk for patients. In the absence of such conditions, the EC certificate shall be
considered as a guarantee of conformity of the device.
Amendment 642
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Regulation (EU) 2017/746
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Article 3 – paragraph 5b (new)
Text proposed by the Commission Amendment
5b. Having regard to the expert panel
opinion referred to in Article 3(4), a
Member State may submit a substantiated
request to the Commission to determine
whether a specific product falls within the
definition of ‘in vitro diagnostic medical
device’ or of ‘accessory for an in vitro
diagnostic medical device’. The
Commission shall decide on the
substantiated request of the Member
State, or on its own initiative, by means of
implementing acts, which shall be adopted
in accordance with the examination
procedure referred to in Article 107(3).
The Commission may ask the expert panel
for clarifications or refer the opinion back
to the expert panel for further
consideration, including in cases where a
Member State’s substantiated request
raises new questions of a scientific or
technical nature.
Or. it
Justification
Paragraph 5aa has been moved from Article 3a(3), as it should only apply to products
already certified and placed on the market, not to those under development. For the latter, in
case of disagreement between the manufacturer and the notified body, the qualification shall
be the responsibility of the competent authority of the Member State where the manufacturer
has its registered place of business. This avoids EU intervention before technical
characteristics and the intended use are defined.
Amendment 643
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Regulation (EU) 2017/746
Article 3 – paragraph 5c (new)
Text proposed by the Commission Amendment
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5c. Where, as a result of the
coordination mechanism or any
subsequent regulatory assessment, a
different regulatory status is deemed to
apply to that product, the clinical data,
non-clinical data, post-market
surveillance and vigilance data and any
other evidence from real-world use
generated or collected during the period
in which the product was lawfully placed
on the market as an in vitro diagnostic
medical device shall remain admissible
and may be taken into account for the
purposes of any subsequent regulatory
application or assessment, where relevant
and scientifically valid.
Or. it
Justification
When assessing the attribution to a product of a status other than that of an in vitro
diagnostic medical device, the competent authority should consider its ability to comply with
all applicable requirements, taking into account clinical, non-clinical, post-market, vigilance
data and real-world use. This avoids requalification making it de facto impossible for them to
be marketed under an alternative regulatory framework.
Amendment 644
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Regulation (EU) 2017/746
Article 3a – paragraph 1
Text proposed by the Commission Amendment
1. A competent authority, a notified
body, a manufacturer, a developer of a
product or the Commission may submit a
substantiated request for an opinion from
an expert panel referred to in Article 106 of
Regulation (EU) 2017/745 on the question
whether a specific product, or category or
group of products, falls within the
definitions of ‘in vitro diagnostic medical
device’ or ‘accessory for an in vitro
1. A competent authority may submit
a substantiated request for an opinion from
an expert panel referred to in Article 106 of
Regulation (EU) 2017/745 on the question
whether a specific product falls within the
definitions of ‘in vitro diagnostic medical
device’ or ‘accessory for an in vitro
diagnostic medical device’. Where, in such
a request, the requester considers that the
product in question is an in vitro diagnostic
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diagnostic medical device’. Where, in such
a request, the requester considers that the
product in question is an in vitro diagnostic
medical device, the request shall also
specify the proposed classification of the
device in accordance with Article 47 and
Annex VIII.
medical device, the request shall also
specify the proposed classification of the
device in accordance with Article 47 and
Annex VIII.
Or. it
Justification
The mechanism should only apply to IVDs not yet EC certified or placed on the market, as
those already placed on the market are covered by Article 3. This limit makes it possible to
resolve qualification issues before certification, ensuring legal certainty and predictability.
The procedure should only be triggered by the competent authorities, without other actors
having a direct role, including the developer – a term not defined by the Regulation.
Amendment 645
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Regulation (EU) 2017/746
Article 3a – paragraph 2
Text proposed by the Commission Amendment
2. The expert panel shall provide its
opinion without undue delay. The
requester shall give utmost consideration to
the opinion of the expert panel.
2. The expert panel shall provide its
opinion within 60 days of receipt of the
request. The requester shall give utmost
consideration to the opinion of the expert
panel.
Or. fr
Amendment 646
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point i – point 3
Regulation (EU) 2017/746
Article 5 – paragraph 5 – subparagraph 1 – point d
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Text proposed by the Commission Amendment
(3) point (d) is deleted; (3) point (d) is amended as follows:
(d) the health institution justifies in its
documentation that the target patient
group’s specific needs cannot be met, or
cannot be met at the appropriate level of
performance by an equivalent device
available on the market;
Or. it
Justification
The increased flexibility for in-house devices is welcomed, but the transition to a CE marked
equivalent should take place within 3 years, based on a plan that ensures continuity of care
and patient safety. The maximum period of 10 years is excessive. We also propose deleting
paragraph 7, as amendments to the GSPRs in Annex I should remain subject to the ordinary
legislative procedure.
Amendment 647
Kateřina Konečná
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point i – point 4
Regulation (EU) 2017/746
Article 5 – paragraph 5 – subparagraph 1 – point e
Text proposed by the Commission Amendment
(e) upon request by a competent
authority, the health institution provides
information on the use of such devices to
its competent authority, which shall
include the justification referred to in point
(a);;
(e) upon request by a competent
authority, the health institution provides
information on the use of such devices and
if and how they are shared with other
health institutions, to its competent
authority, which shall include the
justification referred to in point (a);
Or. en
Amendment 648
Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point i – point 4
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Regulation (EU) 2017/746
Article 2 – points 78a (new), 78b (new) and 78c (new)
Text proposed by the Commission Amendment
(ea) The following points are added:
(78) ‘breakthrough device’ means a novel
medical device or in vitro diagnostic
medical device expected to provide a
significant positive clinical benefit
through either of the following:
- Offering a significant positive clinical
impact on patients or public health
compared to available alternatives and the
state of the art, or
- Fulfilling an unmet medical need where
there is an absence or insufficiency of
available alternative options for that
purpose.
(79): 'orphan devices' means a medical
device intended for a disease or condition
affecting not more than 12,000
individuals in the Union per year and’;
- there is insufficiency of available
alternative options for the treatment,
diagnosis, or prevention of this
disease/condition, or
- the device will offer an option that will
provide an expected clinical benefit
compared to available alternatives or state
of the art for the treatment, diagnosis, or
prevention of this disease/condition,
taking into account both device and
patient population specific factors.
(79a) ‘orphan IVD device’ means an in
vitro diagnostic medical device intended to
provide information on a disease or
condition that presents in not more than 5
in 10 000 individuals in the Union per
year;
- there is insufficiency of available
alternative options for the treatment,
diagnosis, or prevention of this
disease/condition, or
- the device will provide a clinical benefit
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compared to available alternatives or the
state of the art (80) ‘paediatric device’
means a medical devices intended for a
use in the age group until 18 years of age.
Further factors may need to be
considered.
Or. en
Justification
Clear and objective definitions establish transparent eligibility criteria for the regulatory
measures applicable to these categories of devices, while ensuring that such measures are
reserved for devices addressing unmet medical needs, rare diseases or conditions, or specific
paediatric populations. This contributes to a predictable regulatory framework that supports
innovation without compromising the high level of protection of health and safety required by
this Regulation.
Amendment 649
Kateřina Konečná
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point i – point 5
Regulation (EU) 2017/746
Article 5 – paragraph 5 – point f – point iii
Text proposed by the Commission Amendment
(iii) a declaration either that the health
institution is accredited to the standard
referred to in point (c) or that the devices
meet the relevant general safety and
performance requirements set out in Annex
I and, where applicable, information on
which requirements are not fully met with
a reasoned justification therefor;;
(iii) a declaration either that the health
institution is accredited to the standard
referred to in point (c) or that the devices
meet the relevant general safety and
performance requirements set out in Annex
I and, where applicable, information on
which requirements are not fully met with
a reasoned justification therefor. The
declaration requirements shall be
implemented in a harmonised manner
throughout the Union in order to ensure
their consistent application by the
Member States, while avoiding
unnecessary duplication of conformity
assessment or quality review procedures.
Or. en
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Amendment 650
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point i – point 5
Regulation (EU) 2017/746
Article 5 – paragraph 5 – point f – point iii
Text proposed by the Commission Amendment
(iii) a declaration either that the health
institution is accredited to the standard
referred to in point (c) or that the devices
meet the relevant general safety and
performance requirements set out in Annex
I and, where applicable, information on
which requirements are not fully met with
a reasoned justification therefor;;
(iii) a declaration that the health
institution is accredited to the standard
referred to in point (c) and that the devices
meet the relevant general safety and
performance requirements set out in Annex
I and, where applicable, information on
which requirements are not fully met with
a reasoned justification therefor;;
Or. en
Amendment 651
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point iii
Regulation (EU) 2017/746
Article 5 – paragraph 5 – subparagraph 4
Text proposed by the Commission Amendment
For the purposes of the first subparagraph,
point (a), in the case of a transfer of the
device to another health institution, the
transferring and receiving health
institutions shall ensure traceability of the
device.
For the purposes of the first subparagraph,
point (a), in the case of a transfer of the
device to another health institution, the
transferring and receiving health
institutions shall ensure the traceability of
the device, including, where applicable, by
recording the Unique Device Identifier
(UDI), the identity of the transferring and
receiving health institutions and
information relating to any reprocessing
carried out.
Or. en
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Amendment 652
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a – point iii
Regulation (EU) 2017/746
Article 5 – paragraph 5 – subparagraph 1a (new)
Text proposed by the Commission Amendment
For the purposes of the first
subparagraph, point (d), from the date
that the health institution becomes aware
that the target patient group’s specific
needs can be met by a device available on
the market, it may continue to
manufacture and use its device for a
maximum period of 3 years.
Or. it
Justification
See the rationale for Article 5(5).
Amendment 653
Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point a a (new)
Regulation (EU) 2017/746
Article 5 – paragraph 5 – introductory part
Text proposed by the Commission Amendment
(aa) in paragraph 5, the introductory
part is replaced by the following: "5. With
the exception of the relevant general
safety and performance requirements set
out in Annex I, the requirements of this
Regulation shall not apply to devices
manufactured and used only within
health institutions established in the
Union provided that all of the following
conditions are met:
Or. en
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Justification
The rapporteur's text opens the door to laboratories established outside the Union. This
creates risk for patients because EU competent authorities have no equivalent power to
inspect or enforce the applicable requirements against a laboratory established in a third
country.
Accreditation status alone does not establish that a third- country institution operates under a
regulatory framework with comparable oversight, enforcement powers, and patient safety
safeguards; it only confirms that the laboratory meets a technical standard, not that a
competent authority stands behind it.
The practical risk to patients is that a laboratory-developed test manufactured outside the
Union could reach EU patients via cross-border sample referral, with no EU or Member
State authority able to inspect the originating laboratory or enforce corrective action if
something goes wrong.
Amendment 654
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point b
Regulation 2017/746
Article 5 – paragraph 7
Text proposed by the Commission Amendment
7. The Commission is empowered to
adopt delegated acts in accordance with
Article 108, to amend the general safety
and performance requirements set out in
Annex I in order to adapt them to
scientific or technical progress or to
international developments, or to add
requirements in relation to emerging risks
or technologies.
deleted
Or. fr
Amendment 655
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point b
Regulation (EU) 2017/746
Article 5 – paragraph 7
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Text proposed by the Commission Amendment
7. The Commission is empowered to
adopt delegated acts in accordance with
Article 108, to amend the general safety
and performance requirements set out in
Annex I in order to adapt them to
scientific or technical progress or to
international developments, or to add
requirements in relation to emerging risks
or technologies.
deleted
Or. it
Justification
See the rationale for Article 5(5).
Amendment 656
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point b
Regulation (EU) 2017/746
Article 5 – paragraph 8
Text proposed by the Commission Amendment
When adopting implementing acts
pursuant to paragraph 6 of this Article,
delegated acts pursuant to paragraph 7 of
this Article or Common Specifications
pursuant to Article 9 of this Regulation
concerning devices that are high-risk AI
systems as referred to in Article 6(1) of
Regulation (EU) 2024/1689 of the
European Parliament and of the
Council**, or that use high-risk AI
systems as safety components, the
Commission shall take into account the
requirements set out in Chapter III,
Section 2, of that Regulation.
deleted
Or. en
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Amendment 657
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point b
Regulation (EU) 2017/746
Article 5 – paragraph 8
Text proposed by the Commission Amendment
When adopting implementing acts
pursuant to paragraph 6 of this Article,
delegated acts pursuant to paragraph 7 of
this Article or Common Specifications
pursuant to Article 9 of this Regulation
concerning devices that are high-risk AI
systems as referred to in Article 6(1) of
Regulation (EU) 2024/1689 of the
European Parliament and of the
Council**, or that use high-risk AI
systems as safety components, the
Commission shall take into account the
requirements set out in Chapter III,
Section 2, of that Regulation.
deleted
Or. en
Amendment 658
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 5 – point b
Regulation (EU) 2017/746
Article 5 – paragraph 8
Text proposed by the Commission Amendment
When adopting implementing acts pursuant
to paragraph 6 of this Article, delegated
acts pursuant to paragraph 7 of this
Article or Common Specifications pursuant
to Article 9 of this Regulation concerning
devices that are high-risk AI systems as
referred to in Article 6(1) of Regulation
(EU) 2024/1689 of the European
Parliament and of the Council**, or that
When adopting implementing acts pursuant
to paragraph 6 of this Article or Common
Specifications pursuant to Article 9 of this
Regulation concerning devices that are
high-risk AI systems as referred to in
Article 6(1) of Regulation (EU) 2024/1689
of the European Parliament and of the
Council**, or that use high-risk AI systems
as safety components, the Commission
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use high-risk AI systems as safety
components, the Commission shall take
into account the requirements set out in
Chapter III, Section 2, of that Regulation.
shall take into account the requirements set
out in Chapter III, Section 2, of that
Regulation.
Or. fr
Amendment 659
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Proposal for a regulation
Article 2 – paragraph 1 – point 6 – point b
Regulation (EU) 2019/746
Article 6 – paragraph 4
Text proposed by the Commission Amendment
4. A Member State may, on grounds
of protection of public health, require a
provider of a service, as defined Article
1(1), point (b), of Directive (EU)
2015/1535, or the provider of the service
referred to in paragraph 2, to cease its
activity.;
4. A Member State may, on grounds
of protection of public health, require a
provider of a service, as defined Article
1(1), point (b), of Directive (EU)
2015/1535, or the provider of the service
referred to in paragraph 2, to cease its
activity when justified and proportionate
on grounds of safety and public health;
Or. fr
Amendment 660
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 7
Regulation (EU) 2017/746
Article 7 – subparagraph 2
Text proposed by the Commission Amendment
Without prejudice to national law
regarding the exercise of the medical
profession, the first subparagraph shall also
apply to devices used for the provision of a
service referred to in Article 6(2).;
Without prejudice to national law
regarding the exercise of the medical
profession, the first subparagraph shall also
apply to devices used for the provision of a
service referred to in Article 6(2). When
implementing this Article, Member States
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shall not introduce or maintain prior
monitoring or authorisation systems for
the advertising of devices in order to avoid
obstacles to the free movement of goods
within the Union. Member States shall
remain competent to act ex post, including
by prohibiting or sanctioning advertising
practices that do not meet the
requirements set out in this Article, in
accordance with Union and national law.
Or. it
Justification
This amendment aims to maintain harmonised EU rules on the advertising and declaration of
IVDs, avoiding national pre-authorisation or notification systems that would fragment the
internal market. A single framework reduces the red tape, upholds the application of Article 7
in the post-market phase and ensures more consistent monitoring, limiting divergent
interpretations and distortions of competition.
Amendment 661
Laurent Castillo, Margarita de la Pisa Carrión, Ondřej Knotek, Marie-Luce Brasier-
Clain, Valérie Deloge, Viktória Ferenc
Proposal for a regulation
Article 2 – paragraph 1 – point 8
Regulation (EU) 2017/746
Article 9 – paragraph 1 – first paragraph
Text proposed by the Commission Amendment
Where no harmonised standards exist or
where relevant harmonised standards are
not sufficient, or where there is a need to
address public health concerns, the
Commission, after having consulted the
MDCG, may, by means of implementing
acts, adopt common specifications (CS) in
respect of the requirements set out in this
Regulation, in particular the reports and
plans to be drawn up by manufacturers, the
general safety and performance
requirements set out in Annex I, the
technical documentation set out in Annexes
II and III, the conformity assessment
procedures set out in Annexes IX, X and
Where no harmonised standards exist or
where relevant harmonised standards are
not sufficient, or where there is a need to
address public health concerns, the
Commission, after having consulted the
MDCG, notified bodies, manufacturers,
healthcare professionals and patient
representatives, may, by means of
implementing acts, adopt common
specifications (CS) in respect of the
requirements set out in this Regulation, in
particular the reports and plans to be drawn
up by manufacturers, the general safety and
performance requirements set out in Annex
I, the technical documentation set out in
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XI, the performance evaluation and PMPF
set out in Annex XIII or the requirements
regarding performance studies set out in
Annexes XIII and XIV.;
Annexes II and III, the conformity
assessment procedures set out in Annexes
IX, X and XI, the performance evaluation
and PMPF set out in Annex XIII or the
requirements regarding performance
studies set out in Annexes XIII and XIV.;
Or. fr
Amendment 662
Marie-Sophie Lanig, Angelika Niebler
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point c
Regulation (EU) 2017/746
Article 10 – paragraph 9
Text proposed by the Commission Amendment
(c) paragraph 9 is deleted; (c) paragraph (9) is replaced by the
following:
Notified Bodies shall rely on relevant
results from audits or certifications
carried out under internationally
recognised quality management schemes,
including ISO 13485 and the Medical
Device Single Audit Program (MDSAP),
where such results are suitable to
demonstrate compliance with the quality
management system requirements and
GSPRs of this Regulation
Or. en
Amendment 663
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point d – point i
Regulation (EU) 2017/746
Article 10 – paragraph 10
Text proposed by the Commission Amendment
When determining the official language of When determining the official language of
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the Union in which the information set out
in Section 20 of Annex I or other
information to be provided by the
manufacturer shall be made available,
Member States shall consider accepting
another official language of the Union in
which the information is made available,
taking into consideration the technical
knowledge, experience, education or
training of the average intended user(s).;
the Union in which the information set out
in Section 20 of Annex I or other
information to be provided by the
manufacturer shall be made available,
Member States shall consider accepting
one or more official language of the Union
in which the information is made available,
taking into consideration the technical
knowledge, experience, education or
training of the average intended user(s).;
Or. en
Amendment 664
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point e
Regulation (EU) 2017/746
Article 10 – paragraph 12
Text proposed by the Commission Amendment
(e) paragraph 12 is deleted; deleted
Or. en
Amendment 665
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point f
Regulation (EU) 2017/746
Article 10 – paragraph 13
Text proposed by the Commission Amendment
(f) in paragraph 13, the third and
fourth subparagraphs are deleted;
deleted
Or. en
Amendment 666
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Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point f
Regulation (EU) 2017/746
Article 10 – paragraph 13
Text proposed by the Commission Amendment
(f) in paragraph 13, the third and
fourth subparagraphs are deleted;
deleted
Or. en
Justification
The texts concerned here give the competent authority the obligation to facilitate patient
access to documentation, where a competent authority believes the patient may be potentially
injured by a certain device. These texts should be maintained to ensure continued access to
information for patients.
Amendment 667
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 9 – point h
Regulation (EU) 2017/746
Article 10 – paragraph 15
Text proposed by the Commission Amendment
(h) paragraph 15 is deleted; (h) paragraph 15 is replaced by the
following:
'Natural or legal persons may claim
compensation for damage caused by a
defective device in accordance with
applicable Union and national law.
Manufacturers shall, in a manner that is
proportionate to the risk class, type of
device and the size of the enterprise, have
measures in place to provide sufficient
financial coverage in respect of their
potential liability under Directive (EU)
2024/2853, without prejudice to more
protective measures under national law;"
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Or. en
Amendment 668
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point a
Regulation (EU) 2017/746
Article 10a – paragraphs 1, 2 and 3
Text proposed by the Commission Amendment
The information referred to in the first
subparagraph shall be provided at least six
months before the anticipated interruption
or discontinuation or, if this is not possible,
without undue delay after the
manufacturer becomes aware of the
anticipated interruption or discontinuation.;
1. The information referred to in the first
subparagraph shall be provided at least six
months before the anticipated interruption
or discontinuation or, where this is not
possible, immediately after becoming
aware of the anticipated interruption or
discontinuation.. The manufacturer shall
specify the reasons for the interruption or
discontinuation in the information
provided to the competent authority in
accordance with Annex XVI . Where the
information initially provided changes,
the manufacturer shall submit an updated
notification without undue delay. The
manufacturer shall notify the competent
authority without undue delay upon the
resumption of normal supply.
2. The competent authority that has
received the information referred to in
paragraph 1 shall, without undue delay,
inform the competent authorities of the
other Member States and the Commission
of the anticipated interruption,
discontinuation or resumption of normal
supply.
3. The economic operators who have
received the information from the
manufacturer in accordance with
paragraph 1 or from another economic
operator in the supply chain shall, without
undue delay, inform any other economic
operators, health institutions and
healthcare professionals to whom they
directly supply the device of the
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anticipated interruption, or
discontinuation or resumption of normal
supply.
Or. en
Amendment 669
Kateřina Konečná
Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point b
Regulation (EU) 2017/746
Article 10a – paragraph 4
Text proposed by the Commission Amendment
4. The Commission, where necessary
in cooperation with the EMA, shall set up,
maintain, and manage an IT system to
facilitate the reporting and information
exchange regarding cases of interruption or
discontinuation of the supply of devices in
accordance with paragraphs 1, 2 and 3.
That IT system shall be integrated in or
interoperable with the European database
on medical devices referred to in Article
30. It shall also enable health institutions
and healthcare professionals to inform
competent authorities about the
unavailability or the immediate risk of
unavailability of devices needed for the
exercise of their professional activity.
4. The Commission, where necessary
in cooperation with the EMA, shall set up,
maintain, and manage an IT system to
facilitate the reporting and information
exchange regarding cases of interruption or
discontinuation of the supply of devices in
accordance with paragraphs 1, 2 and 3.
That IT system shall be integrated in or
interoperable with the European database
on medical devices referred to in Article
30. It shall also enable health institutions
and healthcare professionals to inform
competent authorities about the
unavailability or the immediate risk of
unavailability of devices needed for the
exercise of their professional activity.
The new IT system with information on
shortages of devices shall be publicly
available. Information on this topic shall
be made available in a timely manner for
service providers for them to be able to
adapt to the change.
Or. en
Amendment 670
András Tivadar Kulja
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Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point b
Regulation (EU) 2017/746
Article 10a – paragraph 4
Text proposed by the Commission Amendment
4. The Commission, where necessary
in cooperation with the EMA, shall set up,
maintain, and manage an IT system to
facilitate the reporting and information
exchange regarding cases of interruption or
discontinuation of the supply of devices in
accordance with paragraphs 1, 2 and 3.
That IT system shall be integrated in or
interoperable with the European database
on medical devices referred to in Article
30. It shall also enable health institutions
and healthcare professionals to inform
competent authorities about the
unavailability or the immediate risk of
unavailability of devices needed for the
exercise of their professional activity.
4. The Commission, where necessary
in cooperation with the EMA, shall set up,
maintain, and manage an IT system to
facilitate the reporting and information
exchange regarding cases of interruption or
discontinuation of the supply of devices in
accordance with paragraphs 1, 2 and 3.
That IT system shall be integrated in or
interoperable with the European database
on medical devices referred to in Article
30. It shall also enable health institutions
and healthcare professionals to inform
competent authorities about the
unavailability or the immediate risk of
unavailability of devices needed for the
exercise of their professional activity.
Furthermore, online alerts with
information about shortages shall be
provided to healthcare professionals,
allowing them to prepare and react to
such shortages.
Or. en
Amendment 671
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point b
Regulation (EU) 2017/746
Article 10a – paragraph 4
Text proposed by the Commission Amendment
4. The Commission, where necessary
in cooperation with the EMA, shall set up,
maintain, and manage an IT system to
facilitate the reporting and information
exchange regarding cases of interruption or
4. The Commission, where necessary
in cooperation with the EMA, shall set up,
maintain, and manage a publicly available
IT system to facilitate the reporting and
information exchange regarding cases of
AM\1348819EN.docx 41/169 PE791.891v01-00
EN
discontinuation of the supply of devices in
accordance with paragraphs 1, 2 and 3.
That IT system shall be integrated in or
interoperable with the European database
on medical devices referred to in Article
30. It shall also enable health institutions
and healthcare professionals to inform
competent authorities about the
unavailability or the immediate risk of
unavailability of devices needed for the
exercise of their professional activity.
interruption or discontinuation of the
supply of devices in accordance with
paragraphs 1, 2 and 3. That IT system shall
be integrated in or interoperable with the
European database on medical devices
referred to in Article 30. It shall also enable
health institutions, patients and healthcare
professionals to inform competent
authorities about the unavailability or the
immediate risk of unavailability of devices.
Or. en
Amendment 672
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point b
Regulation (EU) 2017/746
Article 10a – paragraph 5
Text proposed by the Commission Amendment
5. The EMA, in collaboration with the
Executive Steering Group on Shortages of
Medical Devices (MDSSG) established by
Article 21 of Regulation (EU) 2022/123 of
the European Parliament and of the
Council***, shall develop a methodology
to identify the devices, or categories of
devices, for which it is reasonably
foreseeable that an interruption or
discontinuation of supply could result in
serious harm or a risk of serious harm to
patients or public health as referred to in
paragraph 1. Based on that methodology,
the EMA, in collaboration with the
MDSSG and in agreement with the
Commission shall draw up, publish and
keep up to date a list of devices, or
categories of devices, to which paragraphs
1, 2 and 3 shall apply. For the purpose of
this paragraph, the MDCG, representatives
of manufacturers, other relevant actors in
the supply chain for the medical device
sector and representatives of healthcare
5. The EMA, in collaboration with the
Executive Steering Group on Shortages of
Medical Devices (MDSSG) established by
Article 21 of Regulation (EU) 2022/123 of
the European Parliament and of the
Council**, shall develop a methodology
based on objective and transparent
criteria to identify the devices, or
categories of devices, for which it is
reasonably foreseeable that an interruption
or discontinuation of supply could affect
the availability of devices and result in
serious harm or a risk of serious harm to
patients or public health as referred to in
paragraph 1. Based on that methodology,
the EMA, in collaboration with the
MDSSG and in agreement with the
Commission shall draw up, publish and
keep up to date a list of devices, or
categories of devices, to which paragraphs
1, 2 and 3 shall apply. For the purpose of
this paragraph, the MDCG, representatives
of manufacturers, other relevant actors in
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EN
professionals, of patients and of consumers
may be consulted as necessary.
the supply chain for the medical device
sector and representatives of healthcare
professionals, of patients and of consumers
shall be consulted where necessary.
Or. en
Amendment 673
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point b
Regulation 2017/745
Article 10a – paragraph 5
Text proposed by the Commission Amendment
5. The EMA, in collaboration with the
Executive Steering Group on Shortages of
Medical Devices (MDSSG) established by
Article 21 of Regulation (EU) 2022/123 of
the European Parliament and of the
Council***, shall develop a methodology
to identify the devices, or categories of
devices, for which it is reasonably
foreseeable that an interruption or
discontinuation of supply could result in
serious harm or a risk of serious harm to
patients or public health as referred to in
paragraph 1. Based on that methodology,
the EMA, in collaboration with the
MDSSG and in agreement with the
Commission shall draw up, publish and
keep up to date a list of devices, or
categories of devices, to which paragraphs
1, 2 and 3 shall apply. For the purpose of
this paragraph, the MDCG, representatives
of manufacturers, other relevant actors in
the supply chain for the medical device
sector and representatives of healthcare
professionals, of patients and of consumers
may be consulted as necessary.
5. The EMA, in collaboration with the
Executive Steering Group on Shortages of
Medical Devices (MDSSG) established by
Article 21 of Regulation (EU) 2022/123 of
the European Parliament and of the
Council***, shall develop a methodology
to identify the devices, or categories of
devices, for which it is reasonably
foreseeable that an interruption or
discontinuation of supply could result in
serious harm or a risk of serious harm to
patients or public health as referred to in
paragraph 1. Based on that methodology,
the EMA, in collaboration with the
MDSSG and in agreement with the
Commission shall draw up, publish and
keep up to date a list of devices, or
categories of devices, to which paragraphs
1, 2 and 3 shall apply. For the purpose of
this paragraph, the MDCG, representatives
of manufacturers, other relevant actors in
the supply chain for the medical device
sector and representatives of healthcare
professionals, of patients and of consumers
shall be consulted.
Or. en
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Amendment 674
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 10 – point b
Regulation (EU) 2017/746
Article 10a – paragraph 6
Text proposed by the Commission Amendment
The competent authorities of the Member
States or the Commission may request the
manufacturers of devices included in the
list drawn up in accordance with paragraph
5 to provide all necessary information
regarding risks and weaknesses within the
supply chain which may affect the supply
of such devices, including production
capacity and volume of sales.
The competent authorities of the Member
States or the Commission may request the
manufacturers of devices included in the
list drawn up in accordance with paragraph
5 to provide all necessary information
regarding risks and weaknesses within the
supply chain which may affect the supply
of such devices, including production
capacity and volume of sales and
measures taken or planned to mitigate
any interruption or discontinuation of
supply.
Or. en
Amendment 675
Marie-Sophie Lanig, Angelika Niebler
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Regulation (EU) 2017/746
Article 10a – paragraphs 1, 2 and 3
Present text Amendment
(10a) In Article 10a, paragraphs 1, 2
and 3 are replaced as follows:
Article 10aObligations in case of
interruption or discontinuation of supply
of certain devices1. Where a manufacturer
anticipates an interruption or a
discontinuation of the supply of a device,
other than a custom-made device, and
where it is reasonably foreseeable that
such interruption or discontinuation
could result in serious harm or a risk of
serious harm to patients or public health
"1. Where a manufacturer anticipates a
discontinuation of the supply of a device,
other than a custom-made device, it shall
inform the competent authority of the
Member State where it or its authorised
representative is established by entering
the discontinuation date to EUDAMED.
Moreover, economic operators, health
institutions and healthcare professionals to
whom it directly supplies the device, shall
PE791.891v01-00 44/169 AM\1348819EN.docx
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in one or more Member States, the
manufacturer shall inform the competent
authority of the Member State where it or
its authorised representative is established,
as well as the economic operators, health
institutions and healthcare professionals to
whom it directly supplies the device, of the
anticipated interruption or
discontinuation.The information referred
to in the first subparagraph shall, other
than in exceptional circumstances, be
provided at least 6 months before the
anticipated interruption or
discontinuation. The manufacturer shall
specify the reasons for the interruption or
discontinuation in the information
provided to the competent authority.2. The
competent authority that has received the
information referred to in paragraph 1
shall, without undue delay, inform the
competent authorities of the other Member
States and the Commission of the
anticipated interruption or
discontinuation.3. The economic operators
who have received the information from
the manufacturer in accordance with
paragraph 1 or from another economic
operator in the supply chain shall, without
undue delay, inform any other economic
operators, health institutions and healthcare
professionals to whom they directly supply
the device, of the anticipated interruption
or discontinuation.’
be informed of the anticipated
discontinuation without undue delay, to
enable them to alert the competent
authorities to the immediate risk of
unavailability of devices needed for the
exercise of their professional activity in
accordance with paragraph 4, and to
provide information to the Executive
Steering Group on Shortages of Medical
Devices.
2. The competent authority that has
received the information referred to in
paragraph 1 shall, without undue delay,
inform the competent authorities of the
other Member States and the Commission
of the anticipated discontinuation.
3. The economic operators who have
received the information from the
manufacturer in accordance with paragraph
1 or from another economic operator in the
supply chain shall, without undue delay,
inform any other economic operators,
health institutions and healthcare
professionals to whom they directly supply
the device, of the anticipated
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EN
discontinuation."
Or. en
(2024/1860)
Amendment 676
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 11
Regulation (EU) 2017/746
Article 11 – paragraphs 4 and 5
Text proposed by the Commission Amendment
(11) in Article 11, paragraphs 4 and 5
are deleted;
deleted
Or. en
Amendment 677
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 13 – point a
Regulation (EU) 2017/746
Article 15 – paragraph 1
Text proposed by the Commission Amendment
(a) paragraph 1 is replaced by the
following:
deleted
‘1. Manufacturers shall have available
within their organisation at least one
person responsible for regulatory
compliance who possesses the requisite
expertise in the field of in vitro diagnostic
medical devices.;’
Or. en
PE791.891v01-00 46/169 AM\1348819EN.docx
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Justification
Better to maintain specifications for qualifications
Amendment 678
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 13 – point a
Regulation (EU) 2017/746
Article 15 – paragraph 1
Text proposed by the Commission Amendment
1. Manufacturers shall have available
within their organisation at least one
person responsible for regulatory
compliance who possesses the requisite
expertise in the field of in vitro diagnostic
medical devices.;
1. Manufacturers shall have available
within their organisation at least one
person responsible for regulatory
compliance who possesses the requisite
expertise in the field of in vitro diagnostic
medical devices. The requisite expertise
shall be demonstrated by either of the
following qualifications:
(a) a diploma, certificate or other evidence
of formal qualification, awarded on
completion of a university degree or of a
course of study recognised as equivalent
by the Member State concerned, in law,
medicine, pharmacy, engineering or
another relevant scientific discipline, and
at least one year of professional
experience in regulatory affairs or in
quality management systems relating to in
vitro diagnostic medical devices;
(b) four years of professional experience
in regulatory affairs or in quality
management systems relating to in vitro
diagnostic medical devices.
Or. en
Amendment 679
Ruggero Razza, Michele Picaro
Proposal for a regulation
AM\1348819EN.docx 47/169 PE791.891v01-00
EN
Article 2 – paragraph 1 – point 13 – point a
Regulation (EU) 2017/746
Article 15 – paragraph 1
Text proposed by the Commission Amendment
1. Manufacturers shall have available
within their organisation at least one
person responsible for regulatory
compliance who possesses the requisite
expertise in the field of in vitro diagnostic
medical devices.;
1. Manufacturers shall have available
within their organisation at least one
person responsible for regulatory
compliance who possesses the requisite
expertise in the field of in vitro diagnostic
medical devices.
The requisite expertise shall be
demonstrated by either of the following
qualifications:
(a) a diploma, certificate or other evidence
of formal qualification, awarded on
completion of a university degree or of a
course of study recognised as equivalent
by the Member State concerned, in law,
medicine, pharmacy, engineering or
another relevant scientific discipline, and
at least one year of professional
experience in regulatory affairs or in
quality management systems relating to
medical devices;
(b) four years of professional experience
in regulatory affairs or in quality
management systems relating to medical
devices.
Or. it
Justification
Maintaining the training and experience requirements of the PRRC laid down in the MDR
and IVDR is essential to ensure their competence, oversight and accountability. Removing
them would not simplify the framework but would increase the risk of non-compliance and
national divergences, especially in Italy, where the PRRC is subject to specific
responsibilities and penalties. Flexibility for SMEs should not undermine the basic
qualification requirements.
Amendment 680
Tiemo Wölken
Proposal for a regulation
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EN
Article 2 – paragraph 1 – point 13 – point b
Regulation (EU) 2017/746
Article 15 – paragraph 2
Text proposed by the Commission Amendment
Micro and small enterprises within the
meaning of Commission Recommendation
2003/361/EC**** shall not be required to
have the person responsible for regulatory
compliance within their organisation but
shall have such person at their disposal.
Micro and small enterprises within the
meaning of Commission Recommendation
2003/361/EC**** shall not be required to
have the person responsible for regulatory
compliance within their organisation but
shall have such person at their disposal at
all times.
Or. en
Amendment 681
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 13 – point d
Regulation (EU) 2017/746
Article 15 – paragraph 6
Text proposed by the Commission Amendment
(d) paragraph 6 is replaced by the
following:
deleted
‘6. Authorised representatives shall have
permanently and continuously at their
disposal at least one person responsible
for regulatory compliance who possesses
the requisite expertise regarding the
regulatory requirements for in vitro
diagnostic medical devices in the Union.;’
Or. en
Justification
Better to specify qualifications
Amendment 682
Tiemo Wölken
AM\1348819EN.docx 49/169 PE791.891v01-00
EN
Proposal for a regulation
Article 2 – paragraph 1 – point 13 – point d
Regulation (EU) 2017/746
Article 15 – paragraph 6
Text proposed by the Commission Amendment
6. Authorised representatives shall
have permanently and continuously at their
disposal at least one person responsible for
regulatory compliance who possesses the
requisite expertise regarding the regulatory
requirements for in vitro diagnostic
medical devices in the Union.;
6. Authorised representatives shall
have permanently and continuously at their
disposal at least one person responsible for
regulatory compliance who possesses the
requisite expertise regarding the regulatory
requirements for in vitro diagnostic
medical devices in the Union. The
requisite expertise shall be demonstrated
by either of the following qualifications:
(a) a diploma, certificate or other evidence
of formal qualification, awarded on
completion of a university degree or of a
course of study recognised as equivalent
by the Member State concerned, in law,
medicine, pharmacy, engineering or
another relevant scientific discipline, and
at least one year of professional
experience in regulatory affairs or in
quality management systems relating to in
vitro diagnostic medical devices;
(b) four years of professional experience
in regulatory affairs or in quality
management systems relating to in vitro
diagnostic medical devices.
Or. en
Amendment 683
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 14 – point b
Regulation (EU) 2017/746
Article 16 – paragraph 4
Text proposed by the Commission Amendment
(b) paragraph 4 is deleted; (b) paragraph 4 replaced by the
PE791.891v01-00 50/169 AM\1348819EN.docx
EN
following:
' At least 28 days prior to making the
relabelled, refurbished or repackaged
device available on the market,
distributors or importers carrying out any
of the activities referred to in points (a)
and (b) of paragraph 2 shall inform the
manufacturer and the competent
authority of the Member State in which
they intend to make the device available of
their intention to place the relabelled,
refurbished or repackaged device on the
market. Upon request by the competent
authority, the distributor or importer shall
provide a sample or a mock-up of the
relabelled or repackaged device, including
any translated label and instructions for
use. Within the same period of 28 days,
the competent authority may, where it
considers it necessary, require the
distributor or importer to submit a
certificate, issued by a notified body
designated for the type of devices subject
to the activities referred to in points (a)
and (b) of paragraph 2, attesting that the
quality management system of the
distributor or importer complies with the
requirements laid down in paragraph 3.'
Or. en
Amendment 684
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 14 – point b
Regulation (EU) 2017/746
Article 16 – paragraph 4
Text proposed by the Commission Amendment
(b) paragraph 4 is deleted; (b) paragraph 4 is amended as follows:
4. At least 28 days prior to making the
relabelled or repackaged device available
on the market, distributors or importers
carrying out any of the activities
AM\1348819EN.docx 51/169 PE791.891v01-00
EN
mentioned in points (a) and (b) of
paragraph 2 shall inform the
manufacturer of their intention to make
the relabelled or repackaged device
available and, upon request, shall provide
the manufacturer with a sample or mock-
up of the relabelled or repackaged device,
including any translated label and
instructions for use.
Or. it
Justification
Transparency requirements for those who relabel or repackage medical devices should be
maintained. Even when these activities do not give the operator the status of manufacturer,
the original manufacturer should be able to identify and monitor changes affecting
traceability, performance and post-market surveillance. Timely information is essential to
ensuring supply chain integrity and patient safety.
Amendment 685
Adam Jarubas
Proposal for a regulation
Article 2 – paragraph 1 – point 14 – point b
Regulation (EU) 2017/746
Article 16 – paragraph 4
Text proposed by the Commission Amendment
(b) paragraph 4 is deleted; (b) paragraph 4 is amended as follows;
‘
4. At least 28 days prior to making the
relabelled or repackaged device available
on the market, distributors or importers
carrying out any of the activities
mentioned in points (a) and (b) of
paragraph 2 shall inform the
manufacturer of their intention to make
the relabelled or repackaged device
available and, upon request, shall provide
the manufacturer with a sample or
mockup of the relabelled or repackaged
device, including any translated label and
instructions for use.
PE791.891v01-00 52/169 AM\1348819EN.docx
EN
’
Or. en
Justification
Thepurpose of the amendment is to align the IVDR with the approach proposed forArticle 16
of the MDR. It is intended to maintain manufacturer oversight insituations where importers or
distributors relabel or repackage devices, sothat manufacturers continue to be informed of
any changes that could affect thedevice, its labelling or the instructions for use. This
contributes totraceability, supports effective vigilance and post-market surveillance,enables
timely corrective measures where needed, and helps safeguard theintegrity and safe use of
devices across the supply chain.
Amendment 686
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 15 a (new)
Regulation (EU) 2017/746
Article 18 – paragraph 5
Present text Amendment
(15a) In Article 18, paragraph 5 is
replaced by the following:
5. Where applicable, the CE marking
shall be followed by the identification
number of the notified body responsible for
the conformity assessment procedures set
out in Article 48. The identification
number shall also be indicated in any
promotional material which mentions that a
device fulfils the requirements for CE
marking.
"5. The identification number of the
notified body responsible for the
conformity assessment procedures set out
in Article 48 shall be part of the
information to be submitted by the
manufacturer to the UDI database in
accordance with Article 26.. The
identification number shall also be
indicated in any promotional material
which mentions that a device fulfils the
requirements for CE marking."
Or. en
(Regulation (EU) 2017/746)
Amendment 687
Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge, Viktória Ferenc
AM\1348819EN.docx 53/169 PE791.891v01-00
EN
Proposal for a regulation
Article 2 – paragraph 1 – point 18 a (new)
Regulation (EU) 2017/746
Article 25
Text proposed by the Commission Amendment
(18a) Article 25 is amended as follows:
UDI database
The Commission, after consulting the
MDCG, shall set up and manage a UDI
database in accordance with the
conditions and detailed arrangements
provided for in Article 28 of
Regulation (EU) 2017/745. The UDI
database shall be accessible to the public
in all official languages of the Union and
shall respect the principle of business
secrecy.
Or. fr
Amendment 688
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 19
Regulation (EU) 2017/746
Article 26 – paragraph 1
Text proposed by the Commission Amendment
1. Before placing a device, other than
a device for performance study, on the
market, the manufacturer shall provide the
Basic UDI-DI to the UDI database together
with the other core data elements referred
to in Part B of Annex VI related to that
device, as applicable. The manufacturer
shall keep up to date the information
provided to the UDI database.
1. Before placing a device, other than
a device for performance study, on the
market, the manufacturer shall provide the
Basic UDI-DI to the UDI database together
with the other core data elements referred
to in Part B of Annex VI related to that
device, as applicable. The manufacturer
shall keep up to date the information
provided to the UDI database and
introduce any changes without undue
delay and no later than one months after
the change occurs.
Or. en
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EN
Amendment 689
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 20
Regulation (EU) 2017/746
Article 27 – paragraph 2
Text proposed by the Commission Amendment
Where national distributor databases
require information on devices, such
databases shall allow for the retrieval of the
device information from the electronic
systems referred to in Article 30(2), points
(a) and (b).;
Where national distributor databases
require information on devices, such
databases shall allow for the retrieval of the
device information from the electronic
systems referred to in Article 30(2), points
(a) and (b), although it may be necessary
to allow a reasonable period of time for
implementation.;
Or. fr
Amendment 690
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Article 2 – paragraph 1 – point 21 – point b
Regulation (EU) 2017/746
Article 28 – paragraph 2
Text proposed by the Commission Amendment
2. Without undue delay, the
competent authority shall verify the data
entered pursuant to paragraph 1, obtain a
single registration number (‘SRN’) from
the electronic system referred to in
Article 27 and issue it to the manufacturer,
the authorised representative or the
importer’;
2. Within 10 days of receipt of the
complete dossier, the competent authority
shall verify the data entered pursuant to
paragraph 1, obtain a single registration
number (‘SRN’) from the electronic system
referred to in Article 27 and issue it to the
manufacturer, the authorised representative
or the importer’;
Or. fr
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EN
Amendment 691
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 22 – point a
Regulation (EU) 2017/746
Article 29 – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
The summary of safety and performance
shall be written in a way that is clear to
the intended user.
deleted
Or. it
Amendment 692
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 22 – point a
Regulation (EU) 2017/746
Article 29 – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
The summary of safety and performance
shall be written in a way that is clear to the
intended user.
The summary of safety and clinical
performance shall be written in a way that
is clear and understandable to the
intended user and, where relevant to the
patient as a lay person, and shall be made
available to the public via Eudamed.
Or. en
Amendment 693
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 22 – point a
Regulation (EU) 2017/746
Article 29 – paragraph 1 – subparagraph 3
Text proposed by the Commission Amendment
PE791.891v01-00 56/169 AM\1348819EN.docx
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The draft of the summary of safety and
performance shall be part of the
documentation to be submitted to the
notified body involved in the conformity
assessment pursuant to Article 48. The
manufacturer shall ensure that the
summary of safety and performance is
available to the public in Eudamed and
shall mention on the label or instructions
for use where the summary is available. ;
The draft of the summary of safety and
performance shall be part of the
documentation to be submitted to the
notified body involved in the conformity
assessment pursuant to Article 48. Only the
English language version of the summary
shall be subject to validation by the
notified body. The manufacturer shall
ensure that the summary of safety and
performance is available to the public in
Eudamed and shall mention on the label or
instructions for use where the summary is
available. By default, only the English
language version of the summary of
safety and performance shall be provided.
Translations into the other languages
accepted in the Member States shall be
provided upon request within reasonable
time.
Or. it
Justification
The aim is to reduce the financial and administrative burden of translating SSCPs (summaries
of safety and clinical performance) into all EU languages, limiting mandatory translations to
actual demand. Initially providing the SSCP in English would ease the burden on both
manufacturers and the notified bodies, without reducing the safety requirements of the device.
Amendment 694
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 23
Regulation 2017/746
Article 30 – paragraph 2
Text proposed by the Commission Amendment
By way of derogation from the first
subparagraph, the Commission may decide
that one or more of the electronic systems
referred to in that subparagraph are not to
be included in Eudamed. In that case, the
Commission shall ensure that the
electronic system is interoperable with
Eudamed.;
By way of derogation from the first
subparagraph, the Commission may be of
the opinion that one or more of the
electronic systems referred to in that
subparagraph are not to be included in
Eudamed. In that case, the Commission
shall contact the Member States
concerned to clarify the conditions for the
AM\1348819EN.docx 57/169 PE791.891v01-00
EN
interoperability of the electronic system
with Eudamed.;
Or. fr
Amendment 695
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 25 – point b
Regulation (EU) 2017/746
Article 32 – paragraph 4
Text proposed by the Commission Amendment
(b) the following paragraph 4 is
added:
deleted
‘4. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex VII in order
to adapt to technical and scientific
progress regarding conformity assessment
in the field of in vitro diagnostic medical
devices, including developments at
international level.’;
Or. fr
Amendment 696
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Proposal for a regulation
Article 2 – paragraph 1 – point 25 – point b
Regulation (EU) 2017/746
Article 32 – paragraph 4
Text proposed by the Commission Amendment
4. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex VII in order to
adapt to technical and scientific progress
regarding conformity assessment in the
field of in vitro diagnostic medical devices,
4. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex VII in order to
adapt to technical and scientific progress
regarding conformity assessment in the
field of in vitro diagnostic medical devices,
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including developments at international
level.;
including developments at international
level. Before adopting such delegated
acts, the Commission shall consult the
MDCG, notified bodies and
manufacturers’ representatives.;
Or. fr
Amendment 697
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Proposal for a regulation
Article 2 – paragraph 1 – point 27 – point d
Regulation (EU) 2017/746
Article 47 – paragraph 7
Text proposed by the Commission Amendment
7. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex VIII in order
to adapt it to technical or scientific
progress or to take into account
developments regarding classification of
devices at international level.;
7. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex VIII in order
to adapt it to technical or scientific
progress or to take into account
developments regarding classification of
devices at international level. The
Commission shall consult the MDCG and
relevant stakeholders before adopting
delegated acts under this paragraph.;
Or. fr
Amendment 698
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Proposal for a regulation
Article 2 – paragraph 1 – point 29 – point j
Regulation (EU) 2017/746
Article 48 – paragraph 13 – point b
Text proposed by the Commission Amendment
(b) the modalities of unannounced on-
site audits and sample tests to be conducted
(b) the modalities of unannounced on-
site audits and sample tests to be conducted
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by notified bodies in accordance with
Section 3.4 of Annex IX, taking into
account the risk-class and the type of
device;
by notified bodies in accordance with
Section 3.4 of Annex IX, taking into
account the risk-class and the type of
device. The frequency of unannounced
audits shall be proportionate to the risk
profile of the manufacturer and the
conformity history of the device;
Or. fr
Amendment 699
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 29 – point j
Regulation (EU) 2017/745
Article 48 – paragraph 13 – point e
Text proposed by the Commission Amendment
(e) the modalities of the conformity
assessment procedures regarding
breakthrough devices and orphan devices
set out in Article 48a.
(e) the modalities of the conformity
assessment procedures regarding
breakthrough devices, orphan devices, and
paediatric devices set out in Article 48a.
Or. en
Amendment 700
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 29 – point k
Regulation (EU) 2017/746
Article 48 – paragraph 14
Text proposed by the Commission Amendment
(k) the following paragraph 14 is
added:
deleted
‘14. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annexes IX, X and
XI in order to adapt those Annexes to
technical or scientific progress or to
developments regarding conformity
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assessment of devices at international
level and to take into account the needs of
particular devices in view of their special
characteristics.’;
Or. fr
Amendment 701
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 29 a (new)
Regulation (EU) 2017/746
Article 48 – paragraph 1
Present text Amendment
(29a) paragraph 1 is replaced by the
following:
1. Prior to placing a device on the market,
manufacturers shall undertake an
assessment of the conformity of that
device, in accordance with the applicable
conformity assessment procedures set out
in Annexes IX to XI.
‘1. Prior to placing a device on the market,
manufacturers shall undertake an
assessment of the conformity of that
device, in accordance with the applicable
conformity assessment procedures set out
in Annexes IX to XI.
This conformity assessment shall also
cover any ethical dimensions of devices
such as pre-implantation diagnostic
devices. It shall focus, in particular, on
the proportionality of the risks and
benefits and reference to the ethical
aspect in specific documentation intended
for the patient.’
Or. fr
(Regulation (EU) 2017/746, Article 48 - paragraph 1)
Amendment 702
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
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Article 48a – paragraph 1
Text proposed by the Commission Amendment
1. For the conformity assessment of
breakthrough devices and orphan devices,
for which a notified body is involved in the
conformity assessment, the procedures laid
down in Article 48 shall apply subject to
the specific arrangements set out in this
Article.
1. For the conformity assessment of
breakthrough devices, orphan devices, and
paediatric devices, for which a notified
body is involved in the conformity
assessment, the procedures laid down in
Article 48 shall apply subject to the
specific arrangements set out in this
Article.
Or. en
Justification
Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same
challenges: small patient populations, limited clinical data, high development costs and low
commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised
conformity assessment and rolling review, preventing manufacturers from abandoning
devices for children due to disproportionate regulatory burden.
Amendment 703
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 2
Text proposed by the Commission Amendment
2. A device shall be considered a
breakthrough device if it meets the
following criteria:
deleted
(a) the device is expected to introduce in
the Union a high degree of novelty with
respect to the device technology or the
related clinical procedure or the
application of the device in clinical
practice;
(b) the device is expected to provide a
significant positive clinical impact on
patient or public health, for a life-
threatening or irreversibly debilitating
disease or condition, by either of the
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following:
(i) offering a significant positive clinical
or health impact compared to available
alternatives and the state of the art;
(ii) fulfilling an unmet medical need
where there is an absence or insufficiency
of available alternative options for that
purpose.
Or. en
Amendment 704
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 2
Text proposed by the Commission Amendment
2. A device shall be considered a
breakthrough device if it meets the
following criteria:
2. A device shall be considered a
breakthrough device if it meets all of the
following criteria:
Or. en
Amendment 705
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 2 –point b – point i
Text proposed by the Commission Amendment
(i) offering a significant positive
clinical or health impact compared to
available alternatives and the state of the
art;
(i) offering a significant positive
clinical benefit or health impact compared
to available alternatives and the state of the
art;
Or. en
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Amendment 706
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 2 – b – point ii
Text proposed by the Commission Amendment
(ii) fulfilling an unmet medical need
where there is an absence or insufficiency
of available alternative options for that
purpose.
(ii) fulfilling an unmet medical need
where there is an absence or insufficiency
of available alternative options for that
purpose or where the available
alternatives do not adequately address the
medical needs of the target patient
population.
Or. en
Amendment 707
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 2 – point ba (new)
Text proposed by the Commission Amendment
(ba) It has already undergone initial
testing, the assessment of which indicates
that the clinical benefits of assigning it to
the category of breakthrough devices
outweigh the risks.
Or. en
Amendment 708
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
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Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 3
Text proposed by the Commission Amendment
3. A device shall be considered an
orphan device if it meets the following
criteria:
deleted
(a) the device is intended to provide
information on a disease or condition that
presents in not more than 12 000
individuals in the Union per year;
(b) at least one of the following criteria is
met:
(i) there are insufficient available
alternatives;
(ii) the device is expected to provide a
clinical benefit compared to available
alternatives or the state of the art.
Or. en
Amendment 709
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 3 – point a
Text proposed by the Commission Amendment
(a) the device is intended to provide
information on a disease or condition that
presents in not more than 12 000
individuals in the Union per year;
(a) the device is intended to provide
medical information to benefit patient
populations defined by rare biomarkers
and/or clinical indications with a
prevalence of not more than five in 10
thousand persons, as defined by EU
Regulation 141/2000 on orphan medicinal
products
Or. en
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Amendment 710
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a –paragraph 3 – point b – point ii
Text proposed by the Commission Amendment
(ii) the device is expected to provide a
clinical benefit compared to available
alternatives or the state of the art.
(ii) the device is expected to provide a
clinical benefit compared to available
alternatives or the state of the art or where
the available alternatives do not
adequately address the medical needs of
the target patient population
Or. en
Amendment 711
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 5
Text proposed by the Commission Amendment
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device
or of an orphan device, as applicable, may
request advice from the expert panels
referred to in Article 106 of Regulation
(EU) 2017/745 regarding its performance
evaluation strategy and appropriate
analytical or clinical performance data for
the performance evaluation of the device.
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device
or of an orphan device, as applicable, may
request advice from the expert panels
referred to in Article 106 of Regulation
(EU) 2017/745 regarding its performance
evaluation strategy and appropriate
analytical or clinical performance data for
the performance evaluation of the device,
including scientific and regulatory advice
throughout the development of the device.
Where appropriate, the expert panel shall
coordinate with the notified body
concerned in order to facilitate a
coordinated approach to the conformity
assessment of the device.
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Or. en
Amendment 712
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 5
Text proposed by the Commission Amendment
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device
or of an orphan device, as applicable, may
request advice from the expert panels
referred to in Article 106 of Regulation
(EU) 2017/745 regarding its performance
evaluation strategy and appropriate
analytical or clinical performance data for
the performance evaluation of the device.
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device
or of an orphan device and the sponsor of
the clinical trial(s), as applicable, may
request advice from the expert panels
referred to in Article 106 of Regulation
(EU) 2017/745 regarding its performance
evaluation strategy and appropriate
analytical or clinical performance data for
the performance evaluation of the device.
Or. en
Amendment 713
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 5
Text proposed by the Commission Amendment
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device
or of an orphan device, as applicable, may
request advice from the expert panels
referred to in Article 106 of Regulation
(EU) 2017/745 regarding its performance
5. Where the opinion of the expert
panel confirms the fulfilment of the criteria
set out in paragraph 2 or 3 of this Article,
the manufacturer of a breakthrough device,
an orphan device, or a paediatric device as
applicable, may request advice from the
expert panels referred to in Article 106 of
Regulation (EU) 2017/745 regarding its
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evaluation strategy and appropriate
analytical or clinical performance data for
the performance evaluation of the device.
performance evaluation strategy and
appropriate analytical or clinical
performance data for the performance
evaluation of the device.
Or. en
Justification
Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same
challenges: small patient populations, limited clinical data, high development costs and low
commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised
conformity assessment and rolling review, preventing manufacturers from abandoning
devices for children due to disproportionate regulatory burden.
Amendment 714
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 6 – subparagraph 1
Text proposed by the Commission Amendment
For a confirmed breakthrough device or an
orphan device, as applicable, the notified
body involved in the conformity
assessment procedure set out in Article 48
shall prioritise the conformity assessment
and apply, where appropriate, a rolling
review with a view to reduce assessment
timelines.
For a confirmed breakthrough device or an
orphan device, as applicable, the notified
body involved in the conformity
assessment procedure set out in Article 48
shall prioritise the conformity assessment
and apply, where appropriate, a rolling
review with a view to reduce assessment
timelines, while ensuring that the
conformity assessment remains
scientifically robust and that the
applicable requirements of this
Regulation continue to be fulfilled.
Or. en
Amendment 715
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 30
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Regulation (EU) 2017/746
Article 48a – paragraph 6 – subparagraph 1
Text proposed by the Commission Amendment
For a confirmed breakthrough device or an
orphan device, as applicable, the notified
body involved in the conformity
assessment procedure set out in Article 48
shall prioritise the conformity assessment
and apply, where appropriate, a rolling
review with a view to reduce assessment
timelines.
For a confirmed breakthrough device, an
orphan device, or a paediatric device, as
applicable, the notified body involved in
the conformity assessment procedure set
out in Article 48 shall prioritise the
conformity assessment and apply, where
appropriate, a rolling review with a view to
reduce assessment timelines.
Or. en
Amendment 716
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 6 – subparagraph 2
Text proposed by the Commission Amendment
The notified body shall give due
consideration to an opinion or advice
provided by the expert panel in accordance
with paragraph 4 or 5 and, where it does
not follow such opinion or advice, it shall
provide duly justified reasons. The notified
body may ask the expert panel to clarify
the opinion it has provided.
The notified body shall be able to
participate in the provision of joint advice
set out in paragraph 5 and give due
consideration to an opinion or advice
provided by the expert panel in accordance
with paragraph 4 or 5 and, where it does
not follow such opinion or advice, it shall
provide duly justified reasons. The notified
body may ask the expert panel to clarify
the opinion it has provided.
Or. en
Amendment 717
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
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Article 48a – paragraph 6a (new)
Text proposed by the Commission Amendment
6a. For companion diagnostics and
drug device products, the notified body
involved in the conformity assessment
procedure set out in Article 48 shall
prioritise the conformity assessment and
apply, where appropriate, a rolling review
with a view to reduce assessment timelines
to align with the accelerated review
timelines for the corresponding medicinal
product (e.g. centralized MAA under
accelerated assessment). The notified
body shall in this case provide expedited
approval timelines to avoid a lack of
patient access to the corresponding
medicinal product.
Or. en
Amendment 718
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 7
Text proposed by the Commission Amendment
The notified body shall issue a certificate
pursuant to Article 51 where the pre-
market clinical evidence, even if based on
limited clinical performance data, is
deemed adequate, provided that either of
the following conditions is fulfilled:
The notified body shall issue a certificate
pursuant to Article 51 where the pre-
market clinical evidence is deemed
adequate, provided that all of the following
conditions are fulfilled:
Or. en
Amendment 719
Tiemo Wölken
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Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 7 – point b
Text proposed by the Commission Amendment
(b) the benefit-risk ratio of the device
is favourable and the manufacturer
commits to providing additional data from
post-market performance follow-up
activities.
(b) the benefit-risk ratio of the device
is favourable and the manufacturer
commits to providing additional data from
post-market performance follow-up
activities, in accordance with a post-
market clinical follow-up plan containing
appropriate milestones and timelines for
the generation of additional clinical
evidence.
Or. en
Amendment 720
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 7 – subparagraph 2
Text proposed by the Commission Amendment
Where appropriate, the notified body shall
limit the validity of the certificate and
specify any conditions for or limitations to
the certificate’s validity in accordance with
Article 51, such as specific post-market
performance follow-up activities to be
conducted within a specified period of
time.
The notified body shall limit the validity of
the initial certificate to a maximum of five
years and specify any conditions for or
limitations to the certificate’s validity in
accordance with Article 51, such as
specific post-market performance follow-
up activities to be conducted within a
specified period of time. Where the
manufacturer fails to fulfil the post-
market clinical follow-up obligations
attached to the certificate within the
specified timeframe, the certificate shall
not be renewed by the notified body. The
notified body shall only extend the validity
of the certificate, following an assessment
performed in accordance with Annex VII,
Section 4.11.
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Or. en
Amendment 721
Viktória Ferenc, Ondřej Knotek
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 7 – subparagraph 2
Text proposed by the Commission Amendment
Where appropriate, the notified body shall
limit the validity of the certificate and
specify any conditions for or limitations to
the certificate’s validity in accordance with
Article 51, such as specific post-market
performance follow-up activities to be
conducted within a specified period of
time.
Where appropriate, the validity of the
initial certificate shall be limited to a
maximum of five years. The notified body
shall specify any conditions for the
certificate’s validity in accordance with
Article 51, including, where necessary,
specific post-market clinical follow-up
activities within a defined timeframe. The
certificate may be renewed where the
manufacturer has demonstrated
compliance with the applicable post-
market clinical follow-up requirements.
Or. en
Justification
The proposed amendment facilitates earlier access for breakthrough, orphan and niche
devices while ensuring that if, for example, limited clinical data is provided, this is balanced
by clear safeguards including a time-limited initial certificate and binding post-market
clinical follow-up activities
Amendment 722
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 7 – subparagraph 2
Text proposed by the Commission Amendment
Where appropriate, the notified body shall
limit the validity of the certificate and
Where appropriate, the validity of the
initial certificate shall be limited to a
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specify any conditions for or limitations to
the certificate’s validity in accordance with
Article 51, such as specific post-market
performance follow-up activities to be
conducted within a specified period of
time.
maximum of five years. The notified body
shall specify any conditions for the
certificate’s validity in accordance with
Article 51, including, where necessary,
specific post-market clinical follow-up
activities within a defined timeframe. The
certificate may be renewed where the
manufacturer has demonstrated
compliance with the applicable post-
market clinical follow-up requirements.
Or. en
Amendment 723
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 7 – subparagraph 2
Text proposed by the Commission Amendment
Where appropriate, the notified body shall
limit the validity of the certificate and
specify any conditions for or limitations to
the certificate’s validity in accordance with
Article 51, such as specific post-market
performance follow-up activities to be
conducted within a specified period of
time.
For breakthrough devices and where
appropriate for orphan devices, the
notified body shall limit the time of
validity for the certificate and specify any
conditions for or limitations to the
certificate’s validity in accordance with
Article 56, such as a requirement for the
manufacturer to conduct specific post-
market clinical follow-up activities within
a specified period of time.
Or. en
Amendment 724
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 8
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Text proposed by the Commission Amendment
8. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 in order to amend this Article
to adapt to technical and scientific progress
and to take into account developments
regarding conformity assessment of
breakthrough devices or orphan devices at
international level.
8. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 in order to amend this Article
to adapt to technical and scientific progress
and to take into account developments
regarding conformity assessment of
breakthrough devices, orphan devices or
paediatric devices at international level.
Or. en
Amendment 725
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 9
Text proposed by the Commission Amendment
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices or
orphan devices set out in this Article.
Those implementing acts shall be adopted
in accordance with the examination
procedure referred to in Article 107(3).
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices or
orphan devices set out in this Article,
including arrangements for rolling
review, interactions with expert panels
and procedural timelines for prioritized
assessments.Those implementing acts shall
be adopted in accordance with the
examination procedure referred to in
Article 107(3).
Or. en
Amendment 726
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 9
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Text proposed by the Commission Amendment
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices or
orphan devices set out in this Article.
Those implementing acts shall be adopted
in accordance with the examination
procedure referred to in Article 107(3).
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices,
orphan devices or niche devices set out in
this Article, including mechanisms for
prioritisation and rolling review by
notified bodies.Those implementing acts
shall be adopted in accordance with the
examination procedure referred to in
Article 107(3).
Or. en
Amendment 727
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Regulation (EU) 2017/746
Article 48a – paragraph 9
Text proposed by the Commission Amendment
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices or
orphan devices set out in this Article.
Those implementing acts shall be adopted
in accordance with the examination
procedure referred to in Article 107(3).
9. The Commission may, by means of
implementing acts, lay down further details
of the procedure for the conformity
assessment of breakthrough devices,
orphan devices or paediatric devices set
out in this Article. Those implementing
acts shall be adopted in accordance with
the examination procedure referred to in
Article 107(3).
Or. en
Justification
Not all paediatric devices qualify as orphan or breakthrough devices, yet they face the same
challenges: small patient populations, limited clinical data, high development costs and low
commercial viability. Explicit inclusion ensures paediatric devices benefit from prioritised
conformity assessment and rolling review, preventing manufacturers from abandoning
devices for children due to disproportionate regulatory burden.
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Amendment 728
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Article 2 – paragraph 1 – point 32
Regulation (EU) 2017/746
Article 50 – paragraph 3
Text proposed by the Commission Amendment
3. The notified body shall give utmost
consideration to the advice of the expert
panel or the EU reference laboratory, as
applicable, and, where needed, take any
appropriate measures, including those
referred to in Article 51(3) and (4).;
3. The notified body shall give utmost
consideration to the advice of the expert
panel or the EU reference laboratory, as
applicable, and, where needed, take any
appropriate measures, including those
referred to in Article 51(3) and (4). If the
notified body does not follow the advice of
the expert panel or the EU reference
laboratory, it shall provide a reasoned
justification for its decision.
Or. fr
Amendment 729
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point a
Regulation (EU) 2017/746
Article 51 – paragraph 2
Text proposed by the Commission Amendment
2. The validity of certificates shall
not be limited in time, unless in
exceptional cases where the notified body
considers it necessary to limit the period
of validity based on duly justified grounds.
In those cases, the notified body shall
indicate the period of validity on the
certificate. If the period of validity of the
certificate is limited, on application by the
manufacturer, the notified body may,
deleted
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following an assessment performed in
accordance with Annex VII, Section 4.11,
extend the validity of the certificate. Any
supplement to a certificate shall remain
valid as long as the certificate which it
supplements is valid.;
Or. en
Amendment 730
Kateřina Konečná
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point a
Regulation (EU) 2017/746
Article 51 – paragraph 2
Text proposed by the Commission Amendment
2. The validity of certificates shall not
be limited in time, unless in exceptional
cases where the notified body considers it
necessary to limit the period of validity
based on duly justified grounds. In those
cases, the notified body shall indicate the
period of validity on the certificate. If the
period of validity of the certificate is
limited, on application by the
manufacturer, the notified body may,
following an assessment performed in
accordance with Annex VII, Section 4.11,
extend the validity of the certificate. Any
supplement to a certificate shall remain
valid as long as the certificate which it
supplements is valid.;
2. The validity of certificates shall not
be limited in time, except for class C and
D or innovative devices for which
certificates shall be valid for the period
they indicate, which shall not exceed five
years. On application by the
manufacturer, the validity of the
certificate may be extended for further
periods, each not exceeding five years,
based on a re-assessment in accordance
with the applicable conformity assessment
procedures. Any supplement to a
certificate shall remain valid as long as
the certificate which it supplements is
valid.
For other class C and class D or
innovative devices, the duration of
certificates may be limited in exceptional
cases where the notified body considers it
necessary to limit the period of validity
based on duly justified grounds. In those
cases, the notified body shall indicate the
period of validity on the certificate. If the
period of validity of the certificate is
limited, on application by the
manufacturer, the notified body may,
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following an assessment performed in
accordance with Annex VII, Section 4.11,
extend the validity of the certificate. Any
supplement to a certificate shall remain
valid as long as the certificate which it
supplements is valid.’;
Or. en
Amendment 731
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point a
Regulation (EU) 2017/746
Article 51 – paragraph 2
Text proposed by the Commission Amendment
2. The validity of certificates shall not
be limited in time, unless in exceptional
cases where the notified body considers it
necessary to limit the period of validity
based on duly justified grounds. In those
cases, the notified body shall indicate the
period of validity on the certificate. If the
period of validity of the certificate is
limited, on application by the
manufacturer, the notified body may,
following an assessment performed in
accordance with Annex VII, Section 4.11,
extend the validity of the certificate. Any
supplement to a certificate shall remain
valid as long as the certificate which it
supplements is valid.;
2. The validity of certificates shall not
be limited in time, unless in exceptional
cases where the notified body considers it
necessary to limit the period of validity
based on duly justified grounds. In those
cases, the notified body shall indicate the
period of validity on the certificate. If the
period of validity of the certificate is
limited, on application by the
manufacturer, the notified body may,
following an assessment performed in
accordance with Annex VII, Section 4.11,
extend the validity of the certificate. Any
supplement to a certificate shall remain
valid as long as the certificate which it
supplements is valid. The validity of the
initial certificate for breakthrough and
orphan devices shall be limited to a
maximum of five years.
Or. en
Amendment 732
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
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Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point b
Regulation (EU) 2017/746
Article 51 – paragraph 2a
Text proposed by the Commission Amendment
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device.’;
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device. The periodic reviews shall not
constitute a reassessment of elements
already assessed during the initial
conformity assessment or previous
assessments, unless duly justified as a
result of significant changes or new
risks.’;
Or. fr
Amendment 733
Ruggero Razza, Michele Picaro
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point b
Regulation (EU) 2017/746
Article 51 – paragraph 2a
Text proposed by the Commission Amendment
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device.;
2a. During the validity of the
certificate, the notified body shall carry out
surveillance activities solely to the extent
provided for in the relevant annex
governing conformity assessment on the
basis of which the certificate was issued
(Annex IX, Annex X or Annex XI). Such
surveillance activities shall be
proportionate to the risk class of the device
and shall not amount to a reassessment of
a scope equivalent to the conformity
assessment carried out for the issue of the
certificate.
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Or. it
Justification
The IVDR certification system already provides for continuous monitoring of certificates,
quality management systems and technical documentation, following a quality assurance
approach. Additional periodic reviews not defined by the Commission proposal would
constitute an overlap in red tape with no real added value. Surveillance should therefore
remain proportionate to the device, the risk class and the applicable annexes.
Amendment 734
Stine Bosse, Billy Kelleher
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point b
Regulation (EU) 2017/746
Article 51 – paragraph 2a
Text proposed by the Commission Amendment
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device.;
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device.
Those periodic reviews shall not constitute
a re-assessment of elements already
assessed during the initial conformity
assessment or previous reviews, unless
duly justified by significant changes or
new risks.;
Or. en
Justification
This amendment ensures proportionality, predictability and efficient use of notified body
resources, while maintaining a high level of patient safety.
Clarifying that periodic reviews shall not re-assess elements already evaluated avoids
duplicative assessments during the certificate validity period. Without this clarification, the
provision risks creating unnecessary administrative burden, longer timelines and reduced
system capacity.
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At the same time, the amendment fully preserves the existing high level of patient safety by
explicitly allowing re-assessment where justified by significant changes or new risks, in line
with a lifecycle and risk-based approach. This text reinforces a predictable and proportionate
oversight system, supports timely patient access, and safeguards the integrity of the MDR
framework in line with the political intention of the Commission's proposal.
Amendment 735
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point b
Regulation (EU) 2017/746
Article 51 – paragraph 2a
Text proposed by the Commission Amendment
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews taking into
consideration developments of the state of
the art. Those reviews shall be
proportionate to the risk class of the
device.;
2a. During the validity of the
certificate, the notified body shall carry out
appropriate surveillance activities,
including periodic reviews, in particular
following a certification extension, taking
into consideration developments of the
state of the art. Those reviews shall be
proportionate to the risk class of the
device.;
Or. en
Amendment 736
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point c
Regulation (EU) 2017/746
Article 51 – paragraph 3
Text proposed by the Commission Amendment
3. Notified bodies may impose
conditions on the certificate’s validity,
such as limiting the intended purpose of a
device or requiring the manufacturer to
undertake specific PMPF studies pursuant
to Part B of Annex XIII.;
3. Notified bodies may impose
conditions on the certificate’s validity,
such as limiting the intended purpose of a
device or requiring the manufacturer to
undertake specific PMPF studies pursuant
to Part B of Annex XIII. The validity of
the initial certificate for breakthrough
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and orphan devices shall be limited to a
maximum of five years.
Or. en
Amendment 737
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point d
Regulation (EU) 2017/746
Article 51 – paragraph 4
Text proposed by the Commission Amendment
Where a notified body finds that the
requirements of this Regulation are no
longer met by the manufacturer, it shall,
taking account of the principle of
proportionality, suspend or withdraw the
certificate issued or impose any conditions
on it unless compliance with such
requirements is ensured by appropriate
corrective action taken by the manufacturer
within an appropriate deadline set by the
notified body.’;
Where a notified body finds that the
requirements of this Regulation are no
longer met by the manufacturer, it shall,
taking account of the principle of
proportionality, suspend or withdraw the
certificate issued or impose any conditions
on it unless compliance with such
requirements is ensured by appropriate
corrective action taken by the manufacturer
within an appropriate deadline set by the
notified body. Before suspending or
withdrawing a certificate, the notified
body must give the manufacturer the
opportunity to submit observations and
propose corrective measures, except
where immediate action is necessary to
remedy an unacceptable risk.’;
Or. fr
Amendment 738
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 33 – point d
Regulation (EU) 2017/746
Article 51 – paragraph 4
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Text proposed by the Commission Amendment
Where a notified body finds that the
requirements of this Regulation are no
longer met by the manufacturer, it shall,
taking account of the principle of
proportionality, suspend or withdraw the
certificate issued or impose any conditions
on it unless compliance with such
requirements is ensured by appropriate
corrective action taken by the manufacturer
within an appropriate deadline set by the
notified body.;
Where a notified body finds that the
requirements of this Regulation are no
longer met by the manufacturer or where
the requirements set out in paragraph 3
are not fulfilled, it shall, taking account of
the principle of proportionality, suspend or
withdraw the certificate issued or impose
any conditions on it unless compliance
with such requirements is ensured by
appropriate corrective action taken by the
manufacturer within an appropriate
deadline set by the notified body.
Or. en
Amendment 739
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 35 – point a
Regulation (EU) 2017/746
Article 54 – paragraph 1
Text proposed by the Commission Amendment
1. By way of derogation from Article
48, on a duly justified request, any
competent authority may authorise for a
limited period of time the placing on the
market or putting into service within the
territory of the Member State concerned of
a specific device for which the applicable
conformity assessment procedures have not
been carried out, provided the use of that
device is in the interest of public health,
patient safety or patient health.;
1. By way of derogation from Article
48, on a duly justified request, any
competent authority may authorise for a
limited period of time the placing on the
market or putting into service within the
territory of the Member State concerned of
a specific device (including orphan and
breakthrough devices) for which the
applicable conformity assessment
procedures have not been carried out,
provided the use of that device is in the
interest of public health, patient safety or
patient health.;
Or. en
Amendment 740
Laurence Trochu
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Proposal for a regulation
Article 2 – paragraph 1 – point 35 – point e
Regulation 2017/746
Article 54 – paragraph 4
Text proposed by the Commission Amendment
In the event of a public health emergency
at Union level recognised in accordance
with Article 23 of Regulation (EU)
2022/2371 of the European Parliament and
of the Council*****, the Commission may,
by means of implementing acts, on its own
initiative after consulting the MDCG,
authorise the placing on the market or
putting into service of a device in
accordance with paragraph 3. The
authorisation shall cease to apply at the
latest when the recognition of the public
health emergency is terminated pursuant to
Article 23(2) of Regulation (EU)
2022/2371. Those implementing acts shall
be adopted in accordance with the
examination procedure referred to in
Article 107(3).
In the event of a public health emergency
at Union level recognised in accordance
with Article 23 of Regulation (EU)
2022/2371 of the European Parliament and
of the Council*****, the Commission may,
by means of implementing acts, on its own
initiative after consulting the MDCG,
authorise the placing on the market or
putting into service of a device in
accordance with paragraph 3. The
authorisation shall cease to apply at the
latest when the recognition of the public
health emergency is terminated pursuant to
Article 23(2) of Regulation (EU)
2022/2371. Those implementing acts shall
be adopted in accordance with the
examination procedure referred to in
Article 107(3) and shall be limited to in
vitro diagnostic devices used for the
medical diagnosis of a serious or life-
threatening disease or condition that is
directly linked to the public health
emergency. Diagnostics authorised in this
way cannot be used as a pretext for the
implementation of measures restricting
fundamental freedoms.
Or. fr
Amendment 741
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 1 – subparagraph 1
Text proposed by the Commission Amendment
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Member States, on their own initiative or
upon a substantiated request by
manufacturer or a prospective
manufacturer, may establish one or more
regulatory sandboxes to which the
application of certain requirements of
Chapters V or VI or of Annexes I, VIII, IX,
X, XI, XIII or XIV would not be
appropriate. The Member States shall
designate the competent authority that is
responsible for the supervision of the
regulatory sandbox.
Member States, on their own initiative or
upon a substantiated request by
manufacturer or a prospective
manufacturer, may establish one or more
regulatory sandboxes to which the
application of certain requirements of
Chapters V or VI or of Annexes I, VIII, IX,
X, XI, XIII or XIV would not be
appropriate in light of the innovative
scientific or technological characteristics
of the device or of an innovative
regulatory approach.The Member States
shall designate the competent authority that
is responsible for the supervision of the
regulatory sandbox.
Or. en
Amendment 742
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 1 – subparagraph 1
Text proposed by the Commission Amendment
Member States, on their own initiative or
upon a substantiated request by
manufacturer or a prospective
manufacturer, may establish one or more
regulatory sandboxes to which the
application of certain requirements of
Chapters V or VI or of Annexes I, VIII, IX,
X, XI, XIII or XIV would not be
appropriate. The Member States shall
designate the competent authority that is
responsible for the supervision of the
regulatory sandbox.
Member States may on their own initiative
establish one or more regulatory sandboxes
to which the application of certain
requirements of Chapters V or VI or of
Annexes I, VIII, IX, X, XI, XIII or XIV
would not be appropriate. The Member
States shall designate the competent
authority that is responsible for the
supervision of the regulatory sandbox.
Or. en
Amendment 743
AM\1348819EN.docx 85/169 PE791.891v01-00
EN
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
Member States may also establish
regulatory sandboxes jointly with other
Member States.
deleted
Or. en
Amendment 744
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 2
Text proposed by the Commission Amendment
2. The activities within a regulatory
sandbox shall take place pursuant to a
specific sandbox plan that clearly identify
the requirements of this Regulation
referred to in paragraph 1, which are
temporarily adapted or waived in the
regulatory sandbox, a justification that the
application of those requirements is not
considered to be appropriate and an
explanation as to how potential risks
related to the adaptation or waiver are to be
controlled and mitigated. The plan shall
also identify the reasonable duration of the
regulatory sandbox necessary to achieve its
objectives and the participants in the
regulatory sandbox and their respective
roles.
2. The activities within a regulatory
sandbox shall take place pursuant to a
specific sandbox plan that clearly identify
the requirements of this Regulation
referred to in paragraph 1, which are
temporarily adapted or, where duly
justified,waived in the regulatory sandbox,
a justification that the application of those
requirements is not considered to be
appropriate and an explanation as to how
potential risks related to the adaptation or
waiver are to be controlled and mitigated.
The plan shall also identify the reasonable
duration of the regulatory sandbox
necessary to achieve its objectives and the
participants in the regulatory sandbox and
their respective roles. Any temporary
adaptation or waiver pursuant to this
Article shall not affect the fundamental
requirements relating to the safety and
performance of devices laid down in this
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Regulation and shall ensure a high level
of protection of public health and patient
safety.
Or. en
Amendment 745
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 2
Text proposed by the Commission Amendment
2. The activities within a regulatory
sandbox shall take place pursuant to a
specific sandbox plan that clearly identify
the requirements of this Regulation
referred to in paragraph 1, which are
temporarily adapted or waived in the
regulatory sandbox, a justification that the
application of those requirements is not
considered to be appropriate and an
explanation as to how potential risks
related to the adaptation or waiver are to be
controlled and mitigated. The plan shall
also identify the reasonable duration of the
regulatory sandbox necessary to achieve its
objectives and the participants in the
regulatory sandbox and their respective
roles.
2. The activities within a regulatory
sandbox shall take place pursuant to a
specific sandbox plan that clearly identify
the requirements of this Regulation
referred to in paragraph 1, which are
temporarily adapted or waived in the
regulatory sandbox, a justification that the
application of those requirements is not
considered to be appropriate and an
explanation as to how potential risks
related to the adaptation or waiver are to be
controlled and mitigated. The plan shall
also identify the exact duration of the
regulatory sandbox necessary to achieve its
objectives and the participants in the
regulatory sandbox and their respective
roles.
Or. en
Amendment 746
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 3
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EN
Text proposed by the Commission Amendment
3. A regulatory sandbox shall be set
up only if the following conditions are met:
3. A regulatory sandbox shall be set
up only if all of the following conditions
are met:
Or. en
Amendment 747
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 3 – point a
Text proposed by the Commission Amendment
(a) the device is expected to address
unmet medical needs or to provide a
significant clinical benefit to patients or to
the health system compared with similar
existing alternatives or the state of the art;
(a) the device is expected to address an
unmet medical needs or to provide a
significant clinical benefit to patients or to
the health system compared with existing
alternatives or the state of the art;
Or. en
Amendment 748
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 3 – point ba (new)
Text proposed by the Commission Amendment
(ba) is designed and conducted in such
a way that the rights, safety, dignity and
well-being of subjects participating in
research activities are protected and
prevail over all other interests.
Or. en
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EN
Amendment 749
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 3 – point ba (new)
Text proposed by the Commission Amendment
(ba) Assigning the device to a
regulatory sandbox would not result in
additional risks when compared to the
standard regulatory procedure outlined in
this Regulation.
Or. en
Amendment 750
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 5
Text proposed by the Commission Amendment
5. Any participant in the regulatory
sandbox shall, without undue delay, inform
the competent authority that is responsible
for the supervision of the regulatory
sandbox about any harm occurred in
relation to the implementation of the
regulatory sandbox. The competent
authority shall take immediate and
adequate corrective measures, including to
suspend, revoke or restrict the scope of the
regulatory sandbox.
5. Any participant in the regulatory
sandbox shall, without undue delay, inform
the competent authority that is responsible
for the supervision of the regulatory
sandbox about any incident, serious
incident or other event that may adversely
affect the safety, health or rights of
patients, users or other persons occurred
in relation to the implementation of the
regulatory sandbox. The competent
authority shall take immediate and
adequate corrective measures, including to
suspend, revoke or restrict the scope of the
regulatory sandbox.
Or. en
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Amendment 751
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 6
Text proposed by the Commission Amendment
6. Manufacturers and prospective
manufacturers participating in a
regulatory sandbox shall remain liable
under applicable Union and national law
for any damage inflicted on third parties as
a result of their activities taking place in
the regulatory sandbox.
6. Participation in a regulatory
sandbox shall not affect the liability of
participants under applicable Union and
national liability law. Participants,
including manufacturers and prospective
manufacturers, shall remain liable for any
harm caused to third parties as a result of
activities carried out within the regulatory
sandbox.
Or. en
Amendment 752
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54b – paragraph 7
Text proposed by the Commission Amendment
7. The Member State shall inform the
Commission and the MDCG about the
establishment of a regulatory sandbox and
keep them informed about its
implementation and outcome.
7. The Member State shall inform the
Commission and the MDCG about the
establishment, implementation and
outcome of the regulatory sandbox. The
Commission and the MDCG may use the
experience gained to support the
development of guidance or to assess
whether adaptations to the Union
regulatory framework are appropriate.
Or. en
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EN
Amendment 753
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 1 – subparagraph 1
Text proposed by the Commission Amendment
The Commission, on its own initiative or
upon a substantiated request by a Member
State, may establish by means of
implementing acts for a limited time and
pursuant to a specific plan, Union
regulatory sandboxes, which shall inform
whether the existing requirements
appropriately regulate a specific type of
device with particular characteristics or
emerging technologies, and there is a risk
that the existing requirements:
The Commission, on its own initiative or
upon a substantiated request by a Member
State, may establish by means of
implementing acts for a limited time and
pursuant to a specific plan, Union
regulatory sandboxes, which shall inform
whether the existing requirements
appropriately regulate a specific type of
device with particular characteristics or
emerging technologies
Or. en
Amendment 754
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 1 – point a
Text proposed by the Commission Amendment
(a) would impede or significantly
delay the development of such devices and
access by healthcare professionals or
patients to those devices; or
deleted
Or. en
Amendment 755
Valentina Palmisano
AM\1348819EN.docx 91/169 PE791.891v01-00
EN
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 1 – point b
Text proposed by the Commission Amendment
(b) would not adequately protect the
health and safety of patients, users or
other persons or other aspects of public
health.
deleted
Or. en
Amendment 756
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
Union regulatory sandboxes shall not
involve the placing on the market or
putting into service of devices which do
not comply with this Regulation.
Union regulatory sandboxes shall not
involve the placing on the market or
putting into service of devices which do
not comply with this Regulation and they
shall comply with the requirements for
setting up regulatory sandboxes set out in
article 54b, paragraph 3.
Or. en
Amendment 757
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 1 – subparagraph 2
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Text proposed by the Commission Amendment
Union regulatory sandboxes shall not
involve the placing on the market or
putting into service of devices which do
not comply with this Regulation.
Union regulatory sandboxes shall not
permit the placing on the market or putting
into service of devices which do not
comply with this Regulation.
Or. en
Amendment 758
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 3
Text proposed by the Commission Amendment
3. The Commission shall inform the
MDCG about the establishment of a
regulatory sandbox and keep it informed
about its outcome.
3. The Commission shall keep the
MDCG informed about the establishment,
implementation and outcome of each
Union regulatory sandbox.
Or. en
Amendment 759
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 4
Text proposed by the Commission Amendment
4. The Commission may, by means of
implementing acts, specify common
principles or the detailed arrangements for
the establishment, operation and
supervision of regulatory sandboxes
pursuant to Article 54b or of Union
regulatory sandboxes pursuant to this
Article. Those implementing acts shall be
adopted in accordance with the
4. The Commission may, by means of
implementing acts, specify common
principles or the detailed arrangements for
the establishment, operation,supervision
and evaluation of regulatory sandboxes
pursuant to Article 54b or of Union
regulatory sandboxes pursuant to this
Article. Those implementing acts shall be
adopted in accordance with the
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examination procedure referred to in
Article 107(3).
examination procedure referred to in
Article 107(3).
Or. en
Amendment 760
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 5
Text proposed by the Commission Amendment
5. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend this Article or Article
54b in order to adapt to scientific, technical
or regulatory progress and to take into
account developments regarding regulatory
sandboxes, including in areas other than
in vitro diagnostic medical devices.;
5. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend this Article or Article
54b in order to adapt to scientific, technical
or regulatory progress and to take into
account the experience gained from their
implementation regarding regulatory
sandboxes.
Or. en
Amendment 761
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36
Regulation (EU) 2017/746
Article 54c – paragraph 5a (new)
Text proposed by the Commission Amendment
5a. The establishment and operation
of a Union regulatory sandbox shall not
affect the protection of public health or
the fundamental requirements relating to
the safety and performance of devices laid
down in this Regulation.
Or. en
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Amendment 762
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36 a (new)
Regulation (EU) 2017/746
Article 54ca (new)
Text proposed by the Commission Amendment
(36a) The following article is inserted
Article 54d
Annual reporting on regulatory
sandboxes
The Commission, with input from the
Member States and, where relevant, the
expert panels referred to in Article 106 of
Regulation (EU) 2017/745, as well as the
MDCG, shall submit an annual report to
the European Parliament and the Council
on the implementation of the regulatory
sandboxes established in accordance with
Articles 54b and 54c. The report shall
include, where appropriate, information
on the number of regulatory sandboxes
established, trends regarding the
categories of in vitro medical devices
participating in regulatory sandboxes,
good practices, difficulties encountered,
lessons learnt, reflections on possible
future adaptations of the regulatory
framework, and recommendations
concerning the establishment and
operation of regulatory sandboxes and,
where relevant, the application of this
Regulation and other Union legal acts
supervised within the regulatory
sandboxes. The Commission shall make
those reports, together with lay summaries
thereof, publicly available.
Or. en
Amendment 763
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EN
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 2 – paragraph 1 – point 36 a (new)
Regulation (EU) 2017/746
Article 54ca (new)
Text proposed by the Commission Amendment
(36a) The following article is inserted
Article 54d
Transparency of regulatory sandboxes
Based on the information received from
Member States pursuant to Article 54b(7)
and on the information shared with the
MDCG pursuant to Article 54c(3), the
European Commission shall draw up and
make publicly available an annual report
with a breakdown on the number of
sandboxes granted, and detailed
information on their implementation and
outcomes
Or. en
Amendment 764
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 36 b (new)
Regulation (EU) 2017/746
Article 54cb (new)
Text proposed by the Commission Amendment
(36b) The following article is inserted
Article 54e
Sandbox plan
1. Prior to the establishment of a
regulatory sandbox, the competent
authority of the Member State or, in the
case of a Union regulatory sandbox, the
Commission shall adopt a sandbox plan.
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The sandbox plan shall:
(a) identify the participants in the
regulatory sandbox and their respective
roles;
(b) define the objectives and scope of the
regulatory sandbox;
(c) identify the provisions of this
Regulation from which temporary
derogations are considered necessary for
the purposes of the regulatory sandbox,
together with the corresponding
safeguards;
(d) establish appropriate measures to
ensure a high level of protection of public
health and patient safety and the rights of
participants;
(e) specify the duration of the regulatory
sandbox and the conditions for its
completion or early termination;
(f) establish the monitoring, reporting and
evaluation arrangements applicable to the
regulatory sandbox.
2. Before approving a sandbox plan, the
competent authority of the Member State
or, in the case of a Union regulatory
sandbox, the Commission shall consult
the MDCG where the regulatory sandbox
is likely to have relevance beyond a single
Member State or where a coordinated
approach would facilitate the consistent
application of this Regulation throughout
the Union. Where appropriate, notified
bodies, laboratories, patient
organisations, healthcare professionals
and other relevant stakeholders shall also
be consulted.
. The Commission shall, after consulting
the MDCG, adopt implementing acts
laying down a common template and
minimum requirements for sandbox
plans, including the information to be
provided regarding objectives,
participants, risk mitigation measures,
monitoring, reporting and evaluation.
Those implementing acts shall be adopted
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in accordance with the examination
procedure referred to in Article 107(3).
4. Upon completion of a regulatory
sandbox, the competent authority
responsible for the national regulatory
sandbox or, in the case of a Union
regulatory sandbox, the Commission shall
submit the sandbox plan and the final
evaluation report to the MDCG. The
MDCG shall take the results of completed
regulatory sandboxes into account when
developing guidance and
recommendations under this Regulation.
Or. en
Amendment 765
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 38 – point d
Regulation (EU) 2017/746
Article 56 – paragraph 8
Text proposed by the Commission Amendment
(d) the following paragraph 8 is
added:
deleted
‘8. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex XIII in the
light of technical and scientific progress
and developments at international level
having due regard to the protection of the
health and safety of patients, users or
other persons and other aspects of public
health.’;
Or. fr
Amendment 766
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
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Proposal for a regulation
Article 2 – paragraph 1 – point 38 – point d
Regulation (EU) 2017/746
Article 56 – paragraph 8
Text proposed by the Commission Amendment
8. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex XIII in the
light of technical and scientific progress
and developments at international level
having due regard to the protection of the
health and safety of patients, users or other
persons and other aspects of public health.;
8. The Commission is empowered to
adopt delegated acts in accordance with
Article 108 to amend Annex XIII in the
light of technical and scientific progress
and developments at international level
having due regard to the protection of the
health and safety of patients, users or other
persons and other aspects of public health.
Before adopting delegated acts, the
Commission shall consult the MDCG,
notified bodies, manufacturers,
healthcare professionals and patient
organisations.;
Or. fr
Amendment 767
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 39
Regulation (EU) 2017/746
Article 56a
Text proposed by the Commission Amendment
For class C and class D devices, a
manufacturer may, prior to its performance
study or clinical performance evaluation,
consult an expert panel as referred to in
Article 106 of Regulation (EU) 2017/745,
with the aim of reviewing the
manufacturer’s intended strategy for
demonstrating clinical performance or
proposals for any clinical performance
study. The manufacturer and the notified
body involved in any future conformity
assessment procedure shall, in the
performance evaluation report and the
performance evaluation assessment report,
For class C and class D devices, an IVD
manufacturer and the sponsor of the
clinical trial(s) may, prior to its
performance study or clinical performance
evaluation, consult an expert panel as
referred to in Article 106 of Regulation
(EU) 2017/745, with the aim of reviewing
the combined study’s intended strategy for
demonstrating clinical performance or
proposals for any clinical performance
study. Notified Bodies should be able to
participate. The IVD manufacturer,
sponsor of the clinical trial(s), and the
notified body involved in any future
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give due consideration to the advice of the
expert panel, and where they do not follow
that advice, they shall provide duly
justified reasons.;
conformity assessment procedure shall, in
the performance evaluation report and the
performance evaluation assessment report,
give due consideration to the advice of the
expert panel, and where they do not follow
that advice, they shall provide duly
justified reasons. They may ask expert
panels to clarify the opinion it has
provided.
Or. en
Amendment 768
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 40 – point b
Regulation (EU) 2017/746
Article 58 – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) where the conduct of the study
involves additional invasive procedures,
including high-risk procedures for
collection of specimens, or other risks for
the subjects of the studies,;
(c) where the conduct of the study
involves additional invasive procedures,
including high-risk procedures for
collection of specimens, or other risks for
the subjects of the studies. Routine venous
or capillary blood collection shall not, in
itself, constitute an additional invasive
procedure for the purposes of this Article,
unless the volume or frequency of blood
collection presents a significant risk to the
subject.
Or. en
Amendment 769
Adam Jarubas
Proposal for a regulation
Article 2 – paragraph 1 – point 40 – point b
Regulation (EU) 2017/746
Article 58 – paragraph 1 – point c
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Text proposed by the Commission Amendment
(c) where the conduct of the study
involves additional invasive procedures,
including high-risk procedures for
collection of specimens, or other risks for
the subjects of the studies,;
(c) where the conduct of the study
involves additional invasive procedures
that might pose a major clinical risk to
subjects, or other risks for the subjects of
the studies, shall, in addition to meeting
the requirements set out in Article 57 and
Annex XIII, be designed, authorised,
conducted, recorded and reported in
accordance with this Article and Articles
59 to 77 and Annex XIV.
Or. en
Justification
The term “invasive procedures” in point c could encompass low-risk activities, such as
standard blood sampling and finger-prick tests, which would nevertheless fall within the
general authorisation requirement for “specimen collection”. This appears inconsistent with
the Commission’s summary, which indicated that the scope would be narrowed. It is also
difficult to reconcile with recital 50, which refers to a simplified approach for low-risk
procedures, including routine blood draws carried out on non-vulnerable individuals.
Amendment 770
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 40 – point b
Regulation (EU) 2017/746
Article 58 – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) where the conduct of the study
involves additional invasive procedures,
including high-risk procedures for
collection of specimens, or other risks for
the subjects of the studies,’;
(c) point (c) is replaced by the
following:
where the conduct of the study involves
additional invasive procedures, excluding
routine blood draws from non-vulnerable
individuals, but including high-risk
procedures for collection of specimens, or
other risks for the subjects of the studies,’;
Or. fr
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Justification
This clarification is necessary and in line with recital 50 of the legislative proposal.
Amendment 771
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 40 – point b
Regulation (EU) 2017/746
Article 58 – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) where the conduct of the study
involves additional invasive procedures,
including high-risk procedures for
collection of specimens, or other risks for
the subjects of the studies,;
(c) Where the conduct of the study
involves additional invasive procedures,
excluding routine blood draws from non-
vulnerable individuals, and including
high-risk procedures for collection of
specimens, or other risk for the subjects of
the studies. ;
Or. en
Amendment 772
Kristoffer Storm
Proposal for a regulation
Article 2 – paragraph 1 – point 40 – point b
Regulation (EU) 2017/746
Article 58 – paragraph 1 – point c
Text proposed by the Commission Amendment
(c) where the conduct of the study
involves additional invasive procedures,
including high-risk procedures for
collection of specimens, or other risks for
the subjects of the studies,;
(c) where the conduct of the study
involves additional invasive procedures
that might pose a major clinical risk to
subjects, or other risks for the subjects of
the studies
Or. en
Amendment 773
Tiemo Wölken
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Proposal for a regulation
Article 2 – paragraph 1 – point 53 – point a – point ii
Regulation (EU) 2017/746
Article 81 –paragraph 1 – subparagraph 2
Text proposed by the Commission Amendment
Manufacturers of class C and class D
devices shall update the PSUR in the first
year after the certificate is issued and every
two years thereafter or when there is a
significant change in the benefit-risk
determination or in the acceptability of
erroneous results. That PSUR shall be part
of the technical documentation specified in
Annex III.;
Manufacturers of class C and class D
devices shall update the PSUR in the first
year after the certificate is issued and every
two years thereafter or when there is a
significant change in the benefit-risk
determination or in the acceptability of
erroneous results. Where the notified body
has limited the validity of a certificate in
accordance with Article 51(3), the PSUR
shall be updated annually for the duration
of that period of limited validity in order
to support the assessment of compliance
with the conditions attached to the
certificate .That PSUR shall be part of the
technical documentation specified in
Annex III.
Or. en
Amendment 774
Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge
Proposal for a regulation
Article 2 – paragraph 1 – point 54 – point -a (new)
Regulation (EU) 2017/746
Article 82 – first paragraph
Text proposed by the Commission Amendment
– in the first subparagraph, the
introductory wording is replaced by the
following:
1. Manufacturers of devices made
available on the Union market, other than
devices for performance study, shall
report to the authority responsible for the
notified body that issued the certificate, in
accordance with Articles 87(5) and (7),
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the following:
Or. fr
Amendment 775
Valentina Palmisano
on behalf of The Left Group
Proposal for a regulation
Article 2 – paragraph 1 – point 54 – point b
Regulation (EU) 2017/746
Article 82 – paragraph 3
Text proposed by the Commission Amendment
3. Manufacturers shall report any
serious incident as referred to in paragraph
1, first subparagraph, point (a),
immediately after they have established
that there is a causal relationship between
that incident and their device or that such
causal relationship is reasonably possible,
and not later than 30 days after they
become aware of the incident.;
3. Manufacturers shall report any
serious incident as referred to in paragraph
1, first subparagraph, point (a),
immediately after they have established
that there is a causal relationship between
that incident and their device or that such
causal relationship is reasonably possible,
and not later than 15 days after they
become aware of the incident.;
Or. en
Justification
To reflect current standards.
Amendment 776
Laurence Trochu
Proposal for a regulation
Article 2 – paragraph 1 – point 54 – point b
Regulation (EU) 2017/746
Article 82 – paragraph 3
Text proposed by the Commission Amendment
3. Manufacturers shall report any
serious incident as referred to in paragraph
1, first subparagraph, point (a),
immediately after they have established
3. Manufacturers shall report any
serious incident as referred to in paragraph
1, first subparagraph, point (a),
immediately after they have established
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that there is a causal relationship between
that incident and their device or that such
causal relationship is reasonably possible,
and not later than 30 days after they
become aware of the incident.;
that there is a causal relationship between
that incident and their device or that such
causal relationship is reasonably possible,
and not later than 15 days after they
become aware of the incident.;
Or. fr
Amendment 777
Adam Jarubas
Proposal for a regulation
Article 2 – paragraph 1 – point 55
Regulation (EU) 2017/746
Article 82a
Text proposed by the Commission Amendment
(55) The following Article 82a is
inserted:
deleted
‘Article 82a
Reporting of actively exploited
vulnerabilities and severe incidents
related to devices
1. Without prejudice to the reporting
obligations regarding serious incidents
and field safety corrective actions set out
in Article 82, the manufacturer of a
device shall report to the computer
security incident response teams
(‘CSIRTs’), designated as coordinators of
the Member States where a device has
been made available, and to the European
Union Agency for Cybersecurity (ENISA),
either of the following:
(a) any actively exploited vulnerability as
defined in Article 3, point (42), of
Regulation (EU) 2024/2847 of the
European Parliament and of the
Council******** contained in the device;
(b) any severe incident as referred in
Article 14(5) of Regulation (EU)
2024/2847 having an impact on the
security of the device.
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2. The manufacturer shall submit the
report referred to in paragraph 1 through
the electronic system referred to in Article
87 not later than 30 days after it becomes
aware of the actively exploited
vulnerability or the severe incident.
3. The report referred to in paragraph 1,
as well as any report submitted by a
manufacturer in accordance with Article
82 that also qualifies as actively exploited
vulnerability or severe incident, shall be
made available simultaneously to the
CSIRTs designated as coordinators of the
Member States in which the device has
been made available and to ENISA
4.
For the purposes of this Article, the
CSIRTs designated as coordinators and
ENISA shall have access to Eudamed.
_____________
******** Regulation (EU) 2024/2847 of
the European Parliament and of the
Council of 23 October 2024 on horizontal
cybersecurity requirements for products
with digital elements and amending
Regulations (EU) No 168/2013 and (EU)
2019/1020 and Directive (EU) 2020/1828
(Cyber Resilience Act) (OJ L, 2024/2847,
20.11.2024, ELI:
http://data.europa.eu/eli/reg/2024/2847/oj
).;’
Or. en
Amendment 778
Adam Jarubas
Proposal for a regulation
Article 2 – paragraph 1 – point 55 a (new)
Regulation (EU) 2017/746
Article 82a a (new)
Text proposed by the Commission Amendment
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(55a) the following Article 82a is
inserted:
‘
Article 82a
Reporting of cybersecurity incidents and
coordinated vulnerability disclosure
1. The manufacturer of a device shall
consider:
(a) any actively exploited vulnerability as
defined in Article 3, point (42), of
Regulation (EU) 2024/2847 of the
European Parliament and of the Council,
contained in the device;
(b) any severe incident as referred in
Article 14(5) of Regulation (EU)
2024/2847 having an impact on the
security of the device as serious incident
which shall be proceeded according to
Article 87 and 89.
2. The manufacturer shall submit initial
report of serious incident referred to in
paragraph 1 through the electronic system
referred to in Article 92 without undue
delay and in any event within 24 hours of
the manufacturer becoming aware of it, to
the competent authority and to the
computer security incident response teams
(‘CSIRTs’), designated as coordinators of
the Member States where a device has
been made available and to ENISA.
3. Competent authorities shall cooperate
with computer security incident response
teams (‘CSIRTs’), designated as
coordinators of the Member States where
a device has been made available, when
resolving serious incidents referred to in
paragraph 1. The cooperation shall
include exchange of all information in
reference to reported exploited
vulnerability or severe incident between
competent authority, CSIRT and ENISA.
4. For the purposes of this Article, the
CSIRTs designated as coordinators and
ENISA shall have access to Eudamed.
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5. CSIRTs may act as coordinator for the
purpose of coordinated vulnerability
disclosure for devices as set out in Article
12 of Directive (EU) 2022/2555 and shall
cooperate with competent authority.
’
Or. en
Justification
Both kinds of incidents referred to in article 87a paragraph 1 in the CRA are considered
triggering immediate notification and having serious impact. We should keep the analogous
perspective. The early warning in article 87a paragraph 2 aligns the provisions with CRA.
Furthermore, if we try to match reporting exploited vulnerabilities and severe incidents as
defined in CRA we should look into timelines which refer to serious public health threat,
because it is a scale relevant to a risk connected to them. The vulnerability or severe incident
not always is connected with risk of death or serious illness. That’s why the provisions of
MDR/IVDR have to specify that. Risk caused by vulnerability in the software influence the
same moment to every user of the device and it may be really significant amount of people. So
if we adjust timelines to MDR/IVDR timelines, the deadline for serious public health threat
would be the most relevant. Furthermore, it has to be clearly specified that CSIRT and CA are
able to cooperate without limitation in reference to exchange of information. Such data are
sensitive and have to be protected, but in reference to MD this exchange is needed because of
safety of patients and users. It is necessary to cover a gap in NIS2 directive, which relates
CVD (coordinated vulnerability disclosure) to ICT products.
Amendment 779
Michele Picaro, Ruggero Razza
Proposal for a regulation
Article 2 – paragraph 1 – point 71 a (new)
Regulation (EU) 2017/746
Article 103
Text proposed by the Commission Amendment
(71a) Article 103 is deleted;
Or. en
Amendment 780
Michele Picaro, Ruggero Razza
Proposal for a regulation
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Article 2 – paragraph 1 – point 72
Regulation (EU) 2017/746
Article 103
Text proposed by the Commission Amendment
(72) Article 103 is amended as follows: deleted
‘(a) in paragraph 1, the reference to
‘Directive 95/46/EC’ is replaced by
‘Regulation (EU) 2016/679’;
(b)
in paragraph 2, the reference to
‘Regulation (EC) No 45/2001’ is replaced
by ‘Regulation (EU) 2018/1725 of the
European Parliament and of the
Council*********.
______________________
********* Regulation (EU) 2018/1725 of
the European Parliament and of the
Council of 23 October 2018 on the
protection of natural persons with regard
to the processing of personal data by the
Union institutions, bodies, offices and
agencies and on the free movement of
such data, and repealing Regulation (EC)
No 45/2001 and Decision No
1247/2002/EC (OJ L 295, 21.11.2018, p.
39, ELI:
http://data.europa.eu/eli/reg/2018/1725/oj
).’
Or. en
Amendment 781
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 77
Regulation (EU) 2017/746
Article 109
Text proposed by the Commission Amendment
(77) Article 109 is deleted; deleted
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Or. en
Amendment 782
Aurelijus Veryga
Proposal for a regulation
Article 2 – paragraph 1 – point 78
Regulation (EU) 2017/746
Article 110 – paragraph 12 – subparagraph 1
Text proposed by the Commission Amendment
By way of derogation from Article 5 and
from paragraphs 3 to 3e of this Article, a
device as referred to in paragraph 3a or
paragraph 3b of this Article that meets the
criteria for an orphan device set out in
Article 48a(3) may be placed on the market
or put into service beyond the dates
referred to in paragraphs 3a and 3b if the
following conditions are met:
By way of derogation from Article 5 and
from paragraphs 3 to 3e of this Article, a
device as referred to in paragraph 3a or
paragraph 3b of this Article that meets the
criteria for an orphan device or niche
device set out in Article 48a(3) or a niche
device may be placed on the market or put
into service beyond the dates referred to in
paragraphs 3a and 3b if the following
conditions are met::
(1)
Or. en
Amendment 783
Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge
Proposal for a regulation
Article 2 – paragraph 1 – point 78
Regulation (EU) 2017/746
Article 110 – paragraph 12 – subparagraph 1
Text proposed by the Commission Amendment
By way of derogation from Article 5 and
from paragraphs 3 to 3e of this Article, a
device as referred to in paragraph 3a or
paragraph 3b of this Article that meets the
criteria for an orphan device set out in
Article 48a(3) may be placed on the market
or put into service beyond the dates
referred to in paragraphs 3a and 3b if the
following conditions are met:
By way of derogation from Article 5 and
from paragraphs 3 to 3e of this Article, a
device as referred to in paragraph 3a or
paragraph 3b of this Article that meets the
criteria for an orphan device or niche
device set out in Article 48a(3) may be
placed on the market or put into service
beyond the dates referred to in paragraphs
3a and 3b if the following conditions are
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met:
Or. en
Justification
By allowing continued market access beyond the transition deadlines for devices that fulfil
unmet medical needs and are actively progressing towards compliance, the provision helps
prevent shortages, supports continuity of care, and ensures that patients and healthcare
professionals retain access to essential technologies for which suitable alternatives may not
exist.
Amendment 784
Tiemo Wölken
Proposal for a regulation
Article 2 – paragraph 1 – point 79 – introductory part
Regulation (EU) 2017/746
Article 111
Text proposed by the Commission Amendment
(79) Article 111 is amended as follows: (79) Article 111 is amended as follows:
'Five years after the date of entry into
force of the Amendment, and every 10
years after, the Commission shall assess
the application of this Regulation and
produce an evaluation report on the
progress towards achievement of the
objectives contained herein, while
maintaining the high level of protection of
health and safety of patients, users and
other persons provided for by this
Regulation. including an assessment of
the resources required to implement this
Regulation. The evaluation shall also
include a review on the functioning of
Article 4.
2. The evaluation shall, in particular,
assess:
(a) the effectiveness of the measures
introduced to simplify the regulatory
framework and reduce the administrative
burden on manufacturers, notified bodies,
laboratories and competent authorities,
including their impact on regulatory
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efficiency, legal certainty and the timely
availability of in vitro diagnostic medical
devices on the Union market;
(b) the functioning and effectiveness of
the regulatory sandboxes established
under this Regulation, including their
contribution to innovation, regulatory
learning, regulatory convergence and the
development of guidance, common
specifications, implementing acts or
legislative proposals;
(c) the effectiveness of the framework for
well-established technologies, including
its impact on regulatory efficiency,
innovation, patient access, post-market
performance and safety, and whether the
eligibility criteria remain appropriate in
light of scientific and technological
developments; (f) the application of the
accelerated conformity assessment
pathway for orphan and breakthrough in
vitro diagnostic medical devices, including
its impact on timely patient access,
innovation, generation of performance
evidence, post-market performance
follow-up and the availability of such
devices throughout the Union;
(d) the impact of the measures
strengthening stakeholder involvement,
including the participation of patients,
healthcare professionals, laboratories and
their representative organisations in the
work of the MDCG, vigilance activities
and Eudamed, and their contribution to
the transparency, quality and legitimacy
of regulatory decision-making;
(e) the functioning of Eudamed, including
its contribution to transparency,
traceability, coordination between
Member States, access to information for
patients, healthcare professionals,
laboratories and the public, and the
effectiveness of its publicly accessible
modules;
(f) the effectiveness of the measures
introduced to improve the availability of
in vitro diagnostic medical devices and to
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prevent or mitigate shortages, including
their impact on continuity of supply,
diagnostic preparedness and the
availability of critical diagnostics within
the Union;
(g) the impact of the measures introduced
to facilitate structured scientific, technical
and regulatory dialogue between
manufacturers and notified bodies on the
efficiency, predictability and quality of
conformity assessment procedures, while
preserving the independence, objectivity
and impartiality of notified bodies;
(h) the impact of the revised framework
on the availability of companion
diagnostics and other high-risk in vitro
diagnostic medical devices supporting
personalised medicine and public health;
(i) whether the simplification measures
introduced by this Regulation have
maintained an appropriate balance
between facilitating innovation and
ensuring the generation of sufficient
scientific validity, analytical performance
and clinical performance evidence
throughout the lifecycle of in vitro
diagnostic medical devices, including
through post-market performance follow-
up;
(j) whether the simplification measures
introduced by this Regulation have had
any unintended consequences affecting
the safety or performance of in vitro
diagnostic medical devices, the
effectiveness of market surveillance,
vigilance or post-market performance
follow-up activities, or the overall level of
protection of public health.
3. The evaluation shall be based, inter
alia, on information provided by Member
States, competent authorities, the Medical
Device Coordination Group, expert
panels, notified bodies, manufacturers,
healthcare professionals, laboratories,
patient organisations and other relevant
stakeholders, as well as data available
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through Eudamed.
4. The Commission shall make the
findings of the evaluation publicly
available. Where appropriate, the
Commission shall accompany the report
with legislative proposals to amend this
Regulation.
Or. en
Amendment 785
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Article 4
Regulation (EU) 2024/1689
Annex I
Text proposed by the Commission Amendment
Article 4 deleted
Amendments to Regulation (EU)
2024/1689
Annex I to Regulation (EU) 2024/1689 is
amended as follows:
(1) in Section A, points 11 and 12 are
deleted;
(2) in Section B, the following points are
added:
‘21. Regulation (EU) 2017/745 of the
European Parliament and of the Council
of 5 April 2017 on medical devices,
amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC
and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the
European Parliament and of the Council
of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive
98/79/EC and Commission Decision
2010/227/EU (OJ L 117, 5.5.2017, p.
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176)..
Or. en
Justification
No change should be made to applicability of the AI act.
Amendment 786
Tiemo Wölken
Proposal for a regulation
Article 4
Regulation (EU) 2024/1689
Annex I
Text proposed by the Commission Amendment
Article 4 deleted
Amendments to Regulation (EU)
2024/1689
Annex I to Regulation (EU) 2024/1689 is
amended as follows:
(1) in Section A, points 11 and 12 are
deleted;
(2) in Section B, the following points are
added:
‘21. Regulation (EU) 2017/745 of the
European Parliament and of the Council
of 5 April 2017 on medical devices,
amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC
and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the
European Parliament and of the Council
of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive
98/79/EC and Commission Decision
2010/227/EU (OJ L 117, 5.5.2017, p.
176)..
Or. en
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Amendment 787
Tomislav Sokol
Proposal for a regulation
Article 4
Regulation (EU) 2024/1689
Annex I
Text proposed by the Commission Amendment
Article 4 deleted
Amendments to Regulation (EU)
2024/1689
Annex I to Regulation (EU) 2024/1689 is
amended as follows:
(1) in Section A, points 11 and 12 are
deleted;
(2) in Section B, the following points are
added:
‘21. Regulation (EU) 2017/745 of the
European Parliament and of the Council
of 5 April 2017 on medical devices,
amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC
and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the
European Parliament and of the Council
of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive
98/79/EC and Commission Decision
2010/227/EU (OJ L 117, 5.5.2017, p.
176)..
Or. en
Amendment 788
Kateřina Konečná
Proposal for a regulation
Article 4
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Regulation (EU) 2024/1689
Annex I
Text proposed by the Commission Amendment
Article 4 deleted
Amendments to Regulation (EU)
2024/1689
Annex I to Regulation (EU) 2024/1689 is
amended as follows:
(1) in Section A, points 11 and 12 are
deleted;
(2) in Section B, the following points are
added:
‘21. Regulation (EU) 2017/745 of the
European Parliament and of the Council
of 5 April 2017 on medical devices,
amending Directive 2001/83/EC,
Regulation (EC) No 178/2002 and
Regulation (EC) No 1223/2009 and
repealing Council Directives 90/385/EEC
and 93/42/EEC (OJ L 117, 5.5.2017, p.1);
22. Regulation (EU) 2017/746 of the
European Parliament and of the Council
of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive
98/79/EC and Commission Decision
2010/227/EU (OJ L 117, 5.5.2017, p.
176)..
Or. en
Amendment 789
Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point a a (new)
Regulation (EU) 2017/745
Annex I – Section 12.2
Present text Amendment
12.2 Devices that are composed of
substances or of combinations of
substances that are intended to be
"12.2 Devices that are composed of
substances or of combinations of
substances that are intended to be
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introduced into the human body, and that
are absorbed by or locally dispersed in the
human body shall comply, where
applicable and in a manner limited to the
aspects not covered by this Regulation,
with the relevant requirements laid down
in Annex I to Directive 2001/83/EC for the
evaluation of absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances and
potential for adverse reactions, as required
by the applicable conformity assessment
procedure under this Regulation.
introduced into the human body, and that
are absorbed by or locally dispersed in the
human body shall be assessed for the
matter referring to absorption,
distribution, metabolism, excretion, local
tolerance, toxicity, interaction with other
devices, medicinal products or other
substances and potential for adverse
reactions, as required by the applicable
conformity assessment procedure under
this Regulation and having regard to the
state of the art and to the characteristics
of the substance(s) concerned."
Or. en
(2017/745)
Justification
Removing the reference to Directive 2001/83/EC (the legislation governing medicinal
products) eliminates an unnecessary source of regulatory uncertainty. Medical devices and
medicinal products operate through different mechanisms and are subject to separate
regulatory frameworks. It is therefore neither appropriate nor scientifically justified to
require medical device manufacturers to address the aspects set out in essential requirement
12.2 using an approach developed for medicinal products, as this may unnecessarily hinder
innovation and delay access to products that meet emerging healthcare needs.
To maintain a high level of patient safety, the amendment preserves the manufacturer's
obligation to rigorously assess those aspects through an approach specifically designed for
medical devices, ensuring equivalent safety outcomes. This is consistent with the initiative’s
main objectives of simplification, legal certainty, and regulatory coherence for medical
devices within the EU.
Amendment 790
Adam Jarubas
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point c a (new)
Regulation (EU) 2017/745
Annex I – Sections 17.4a (new) and 17.4b (new)
Text proposed by the Commission Amendment
(ca) the following sections 17.5 and
17.6 are added:
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‘
17.5 Connected devices shall comply with
the essential cybersecurity requirements
set out in Annex I, Part I, point 2, letter
(a) to (l) of Regulation (EU) 2024/2847 of
the European Parliament and of the
Council, taking into consideration
benefit-risk ratio of the device and
intended user.
17.6 Manufacturer of connected devices
shall fulfil requirements specified in
Annex I, Part II of regulation mentioned
in paragraph 17.5.1.
’
Or. en
Amendment 791
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point d – point i
Regulation (EU) 2017/745
Annex I – Section 23.1 – subparagraph 1
Text proposed by the Commission Amendment
(i) in the first subparagraph, the
second sentence is replaced by the
following:
deleted
‘Such information may appear on the
device itself, on the packaging or in the
instructions for use, taking into account
the following:;’
Or. en
Amendment 792
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point d – point iv
Regulation (EU) 2017/745
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Annex I – Section 23.1 – point i
Text proposed by the Commission Amendment
(i) For a device that is exclusively in
use with a medicinal product in accordance
with Article 19 of [Proposal for a Directive
on the Union code relating to medicinal
products for human use, and repealing
Directive 2011/83/EC and Directive
2009/35/EC] and packaged together with a
medicinal product, the instructions for use
may be included, where needed, as part of
the co-packaging of the medicinal product
with the device. Moreover, the information
on the label of the device may be limited to
the particulars referred to in Section 23.2,
points (a) and (c), where, following
agreement of the competent authority
responsible for the authorisation of the
medicinal product, the following
conditions are met:
(i) For a device that is exclusively in
use with a medicinal product in accordance
with Article 19 of [Proposal for a Directive
on the Union code relating to medicinal
products for human use, and repealing
Directive 2011/83/EC and Directive
2009/35/EC] and packaged together with a
medicinal product, the instructions for use
shall be included, where needed, as part of
the co-packaging of the medicinal product
with the device. Moreover, the information
on the label of the device may be limited to
the particulars referred to in Section 23.2,
points (a) and (c), where, following
agreement of the competent authority
responsible for the authorisation of the
medicinal product, the following
conditions are met:
Or. en
Amendment 793
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point d – point iv
Regulation (EU) 2017/745
Annex I– Section 23.1 – point i – indent 2a (new)
Text proposed by the Commission Amendment
(ia) - electronic or digital means used
to provide access to the instructions for
use shall comply with Regulation (EU)
2016/679 and shall not permit the
identification, profiling or tracking of
patients beyond what is necessary for the
provision of that information.
Or. en
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Amendment 794
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point e – point ii
Regulation (EU) 2017/745
Annex I – Section 23.2 – point o
Text proposed by the Commission Amendment
(ii) point (o) is deleted; deleted
Or. en
Amendment 795
Ruggero Razza, Michele Picaro
Proposal for a regulation
Annex I – paragraph 1 – point 1 a (new)
Regulation (EU) 2017/745
Annex I – Section 12.2
Present text Amendment
12.2 ‘12.2.
Devices that are composed of substances or
of combinations of substances that are
intended to be introduced into the human
body, and that are absorbed by or locally
dispersed in the human body shall comply,
where applicable and in a manner limited
to the aspects not covered by this
Regulation, with the relevant
requirements laid down in Annex I to
Directive 2001/83/EC for the evaluation
of absorption, distribution, metabolism,
excretion, local tolerance, toxicity,
interaction with other devices, medicinal
products or other substances and potential
for adverse reactions, as required by the
applicable conformity assessment
procedure under this Regulation.
Devices that are composed of substances or
of combinations of substances that are
intended to be introduced into the human
body, and that are absorbed by or locally
dispersed in the human body shall, where
applicable, also be assessed for aspects
relating to the absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances and
potential for adverse reactions, as required
by the applicable conformity assessment
procedure under this Regulation and
taking into account the state of the art
and the characteristics of the substances.
Or. it
(2017/745 (MDR))
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Justification
This amendment removes the reference to Directive 2001/83/EC on medicinal products,
which creates legal uncertainty and unnecessary burdens, as medical devices and medicinal
products are governed by separate frameworks. Security remains guaranteed: manufacturers
will continue to assess the relevant aspects of requirement 12.2 with device-specific methods.
The amendment will boost the clarity, regulatory coherence, innovation and the timely
availability of new health solutions.
Amendment 796
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 2 a (new)
Regulation (EU) 2017/745
Annex II – Section 1.1 – point la (new)
Text proposed by the Commission Amendment
(2a) the following point (m) is
introduced:
'an indication of whether the device is
intended for single use or is suitable for
reprocessing for reuse, together with the
grounds for that designation, including
why safe reprocessing cannot be ensured.'
Or. en
Amendment 797
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 4 – point a
Regulation (EU) 2017/745
Annex VI – Part B – point 34a (new)
Text proposed by the Commission Amendment
(35) identification number of the notified
body responsible for the conformity
assessment procedures set out in Article
52.
Or. en
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Amendment 798
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point c
Regulation (EU) 2017/745
Annex VII – Section 1.2.9.
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged.’;
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged. That dialogue may
take the form of structured and interactive
exchanges, including consultations both
before the application is lodged and
throughout the conformity assessment
procedure.
Or. fr
Amendment 799
Aurelijus Veryga
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point c
Regulation (EU) 2017/746
Annex VII – Section 1.2.9
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged.;
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged. These dialogues may
include structured and interactive
exchanges, including pre-submission
consultations, and consultations
throughout the conformity assessment
procedure.;
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Or. en
Amendment 800
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point c
Regulation (EU) 2017/745
Annex VII – Section 1.2.9
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged.;
The notified body shall have documented
procedures in place to offer and carry out
dialogues, including early dialogue, with
the manufacturer before and after an
application for conformity assessment is
lodged.
Or. en
Amendment 801
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point z
Regulation (EU) 2017/745
Annex VII – Section 4.11.
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place relating to periodic
reviews of approved quality management
systems or EU technical documentation
assessment certificates or EU type-
examination certificates.
The notified body shall have documented
procedures in place relating to periodic
reviews of approved quality management
systems or EU technical documentation
assessment certificates or EU type-
examination certificates. Notified bodies,
taking into account the coordination
activities referred to in Article 49, shall
ensure uniform application of these
provisions.
Or. fr
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Amendment 802
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 5 – point z
Regulation (EU) 2017/745
Annex VII – Section 4.11
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place relating to the
extension of the period of validity of a
certificate in cases where it has
exceptionally limited the period of validity.
Those procedures shall require the
manufacturer to submit prior to the expiry
of the certificate the data or documentation
specified by the notified body to enable it
to decide about the extension of the period
of validity of the certificate.;
The notified body shall have documented
procedures in place relating to the
extension of the period of validity of a
certificate in cases where it has limited the
period of validity. Those procedures shall
require the manufacturer to submit prior to
the expiry of the certificate the data or
documentation specified by the notified
body to enable it to decide about the
extension of the period of validity of the
certificate.;
Or. en
Amendment 803
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 5 a (new)
Regulation (EU) 2017/745
Annex VII – Section 1.2.9
Present text Amendment
(5a) Annex VII - 1.2.9 is replaced by
the following:
1.2.9. The requirements laid down in this
Section in no way preclude exchanges of
technical information and regulatory
guidance between a notified body and a
manufacturer applying for conformity
assessment.
"1.2.9. The requirements laid down in this
Section in no way preclude exchanges of
technical information, regulatory guidance
and early dialogue between a notified
body and a manufacturer applying for
conformity assessment. The notified body
shall have documented procedures in
place to offer and carry out dialogues,
including early dialogue, with the
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manufacturer before and after an
application for conformity assessment is
lodged."
Or. en
(Regulation (EU) 2017/745)
Amendment 804
Adam Jarubas
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point b
Regulation (EU) 2017/745
Annex VIII – Section 4.2 – paragraph 1 – indent 2
Text proposed by the Commission Amendment
- if they are intended for use for
channeling or storing blood or other body
liquids or for storing organs, parts of
organs or body cells and tissues, except for
blood bags; by derogation from any other
classification rule, blood bags are
classified as class IIb.;
- if they are intended for use for
channeling or storing blood or other body
liquids or for storing organs, parts of
organs or body cells and tissues, except for
blood bags; blood bags are classified as
class IIb.;
Or. en
Justification
This amendment ensures legal clarity, supporting continuity of supply and regulatory stability
by preserving the recently harmonised classification framework for blood bags under the
MDR. It removes the proposed derogation clause, which would introduce ambiguity by
overruling Rule 14 and creating uncertainty as to the applicable classification for blood bags
containing substances meeting the definition of a medicinal product under Directive
2001/83/EC. Maintaining the current framework avoids reinstating discrepancies in the
regulatory treatment of identical substances depending on whether they are incorporated into
a blood bag or supplied separately, in line with current EMA and MDCG positions. It also
ensures continuity of supply by avoiding the operational burden that any reclassification
would entail, including updates to labelling, technical documentation and national
registrations.
Amendment 805
András Tivadar Kulja
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Proposal for a regulation
Annex I – paragraph 1 – point 6 – point b
Regulation (EU) 2017/745
Annex VIII – Section 4.2 – paragraph 1 – indent 2
Text proposed by the Commission Amendment
- if they are intended for use for
channeling or storing blood or other body
liquids or for storing organs, parts of
organs or body cells and tissues, except for
blood bags; by derogation from any other
classification rule, blood bags are
classified as class IIb.;
- if they are intended for use for
channeling or storing blood or other body
liquids or for storing organs, parts of
organs or body cells and tissues, except for
blood bags; blood bags are classified as
class IIb.;
Or. en
Amendment 806
Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie
Deloge
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3
Text proposed by the Commission Amendment
Rule 11 shall be applied in a manner that
clearly distinguishes the criteria
determining whether software constitutes
a medical device from the criteria for its
classification under this Annex. The
classification of software shall be based
on its intended purpose and the applicable
classification criteria set out in this Rule.
Or. en
Amendment 807
Sirpa Pietikäinen
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
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Annex VIII – Section 6.3
Text proposed by the Commission Amendment
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease
or condition is classified as class I, unless
the output is intended for a disease or
condition:
A medical device software which is
intended to generate an output that confers
a clinical benefit is classified as class I,
unless the output is intended for:
- Determining clinical management in a
critical situation with a risk of causing
death or an irreversible deterioration of a
person's state of health, in which case it is
classified as class III;
- Determining clinical management in a
serious situation with a risk of causing a
serious deterioration of a person's state of
health or a surgical intervention, or
driving clinical management in a critical
situation in which cases it is classified as
class IIb;
- Determining clinical management in a
non-serious situation or driving clinical
management in a serious situation or
informing clinical management in a
critical or serious situation in which cases
it is classified as class IIa,
except where the software is a 'simple
calculator' intended specifically for use by
healthcare professionals to inform
clinical management in non-time critical
situations regardless of the patient
condition, and, where the calculation is
based on commonly known state-of-the-
art clinical practice and presented
explicitly and transparently for the
professional at the time of use of the
software, in which case the software is
classified as class I.
(This amendment applies throughout the
text. Adopting it will necessitate
corresponding changes throughout.)
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Or. en
(See wording of Annex VIII - Section 6.3 Rule 11, Regulation (EU) 2017/745.)
Justification
Commission proposal for a new rule 11 for software classification is ambiguous and does not
properly achieve the aim of better proportionality, simplification and allowing self-
certification for a larger group of medical device software products.
Amendment 808
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – introductory part
Text proposed by the Commission Amendment
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended for a disease or
condition:
Software which is intended for a medical
purpose and generates an output that is
used is used for diagnosis, treatment,
prevention, monitoring, prediction,
prognosis, compensation or alleviation of a
disease or condition is classified as class I,
unless the output is intended to address a
disease or condition in on of the following
situations:
Or. en
Justification
The Commission's classification language for software is unclear and open to interpretation.
The amendment aligns the wording with international (IMDRF) classification rules and the
Commission's own stated intention — ensuring predictable outcomes, including Class I where
patient risk is genuinely low.
Amendment 809
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – introductory part
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Text proposed by the Commission Amendment
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended for a disease or
condition:
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended:
Or. en
Amendment 810
Aurelijus Veryga
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – introductory part
Text proposed by the Commission Amendment
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended for a disease or
condition:
Software which is intended for a medical
purpose and to generates an output that is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
its output is intended :
Or. en
Amendment 811
Ondřej Knotek, Laurent Castillo, Marie-Luce Brasier-Clain, Viktória Ferenc, Valérie
Deloge
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – introductory part
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Text proposed by the Commission Amendment
Software which is intended to generate an
output that confers a clinical benefit and is
used for diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless the
output is intended for a disease or
condition:
Software which is intended for medical
purpose and generates an output that
confers a clinical benefit and is used for
diagnosis, treatment, prevention,
monitoring, prediction, prognosis,
compensation or alleviation of a disease or
condition is classified as class I, unless its
output is:
Or. en
Amendment 812
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 1
Text proposed by the Commission Amendment
– in a critical situation with a risk of
causing death or an irreversible
deterioration of a person's state of health,
in which case it is classified as class III;
– - to treat or diagnose in a critical
situation, in which case it is class III;
Or. en
Justification
The Commission's classification language for software is unclear and open to interpretation.
The amendment aligns the wording with international (IMDRF) classification rules and the
Commission's own stated intention — ensuring predictable outcomes, including Class I where
patient risk is genuinely low.
Amendment 813
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 1
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Text proposed by the Commission Amendment
– in a critical situation with a risk of
causing death or an irreversible
deterioration of a person's state of health,
in which case it is classified as class III;
– to treat or diagnose a disease or
condition in a critical situation , in which
case it is classified as class III;
Or. en
Amendment 814
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 2
Text proposed by the Commission Amendment
– in a serious situation with a risk of
causing a serious deterioration of a
person's state of health or a surgical
intervention, or to drive clinical
management in a critical situation in which
cases it is classified as class IIb;
– - to treat or diagnose in a serious
situation, or to drive clinical management
in a critical situation, in which cases it is
class IIb;
Or. en
Justification
The Commission's classification language for software is unclear and open to interpretation.
The amendment aligns the wording with international (IMDRF) classification rules and the
Commission's own stated intention — ensuring predictable outcomes, including Class I where
patient risk is genuinely low.
Amendment 815
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 2
Text proposed by the Commission Amendment
– in a serious situation with a risk of – to threat or diagnose a disease or
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causing a serious deterioration of a
person's state of health or a surgical
intervention, or to drive clinical
management in a critical situation in which
cases it is classified as class IIb;
condition in a serious situation , or to drive
clinical management of a disease or
condition in a critical situation in which
cases it is classified as class IIb;
Or. en
Amendment 816
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 3
Text proposed by the Commission Amendment
– in a non-serious situation, or to
drive clinical management in a serious
situation or to inform clinical management
in a critical or serious situation in which
cases it is classified as class IIa.;
– to treat or diagnose a disease or
condition in a non-serious situation, or to
drive clinical management of a disease or
condition in a serious situation or to inform
clinical management for a disease or
condition in a critical situation in which
cases it is classified as class IIa.
Or. en
Amendment 817
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g
Regulation (EU) 2017/745
Annex VIII – Section 6.3 – subparagraph 1 – indent 3
Text proposed by the Commission Amendment
– in a non-serious situation, or to
drive clinical management in a serious
situation or to inform clinical management
in a critical or serious situation in which
cases it is classified as class IIa.;
– - to treat or diagnose in a non-
serious situation, to drive clinical
management in a serious situation or to
inform clinical management in a critical
situation in which cases it is classified as
class IIa.
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Or. en
Justification
The Commission's classification language for software is unclear and open to interpretation.
The amendment aligns the wording with international (IMDRF) classification rules and the
Commission's own stated intention — ensuring predictable outcomes, including Class I where
patient risk is genuinely low.
Amendment 818
Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point g a (new)
Regulation (EU) 2017/745
Annex VIII – Section 7.1
Present text Amendment
All devices incorporating, as an integral
part, a substance which, if used separately,
can be considered to be a medicinal
product, as defined in point 2 of Article 1
of Directive 2001/83/EC, including a
medicinal product derived from human
blood or human plasma, as defined in point
10 of Article 1 of that Directive, and that
has an action ancillary to that of the
devices, are classified as class III.
"All devices incorporating, as an integral
part, a substance which, if used separately,
can be considered to be a medicinal
product, as defined in point 2 of Article 1
of Directive 2001/83/EC, including a
medicinal product derived from human
blood or human plasma, as defined in point
10 of Article 1 of that Directive, and that
have a clinically relevant ancillary action
contributing to the intended medical
purpose, are classified as class III"
Or. en
(2017/745)
Amendment 819
Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo
Proposal for a regulation
Annex I – paragraph 1 – point 6 – point i
Regulation (EU) 2017/745
Annex VIII – Section 7.8
Text proposed by the Commission Amendment
Devices that are composed of substances or Devices that are composed of substances or
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of combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by or locally
dispersed on or in the human body are
classified as:;
of combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by or locally
dispersed in the human body are classified
as:;
Or. en
Amendment 820
Ondřej Dostál
Proposal for a regulation
Annex I – paragraph 1 – point 6 a (new)
Regulation (EU) 2017/745
Annex VIII – Section 5.2
Text proposed by the Commission Amendment
(6a) Section 5.2 is replaced by the
following:
"
All surgically invasive devices intended
for transient use are classified as class IIa
unless they:
- are intended specifically to control,
diagnose, monitor or correct a defect of
the heart or of the central circulatory
system through direct contact with those
parts of the body, in which case they are
classified as class III;
- are surgical instruments regardless of
the body part with which they come into
contact, in which case they are classified
as class I;
- are intended specifically for use in direct
contact with the heart of central
circulatory system or the central nervous
system, in which case they are classified
as class III;
- are intended to supply energy in the
form of ionising radiation in which case
they are classified as class IIb;
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- have a biological effect or are wholly or
mainly absorbed in which case they are
classified as class IIb; or are intended to
administer medicinal products by means
of a delivery system, if such
administration of a medicinal product is
done in a manner that is potentially
hazardous taking account of the mode of
application, in which case they are
classified as class IIb.
"
Or. en
Amendment 821
Ondřej Dostál
Proposal for a regulation
Annex I – paragraph 1 – point 6 b (new)
Regulation (EU) 2017/745
Annex VIII – Section 5.3
Text proposed by the Commission Amendment
(6b) Section 5.3 is replaced by the
following:
"
All surgically invasive devices intended
for short-term use are classified as class
IIa unless they:
- are intended specifically to control,
diagnose, monitor or correct a defect of
the heart or of the central circulatory
system through direct contact with those
parts of the body, in which case they are
classified as class III;
- are intended specifically for use in direct
contact with the heart of central
circulatory system or the central nervous
system, in which case they are classified
as class III;
- are intended to supply energy in the
form of ionising radiation in which case
they are classified as class IIb;
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- have a biological effect or are wholly or
mainly absorbed in which case they are
classified as class III;
- are intended to undergo chemical
change in the body in which case they are
classified as class IIb, except if the devices
are placed in the teeth; or
- are intended to administer medicines, in
which case they are classified as class IIb;
- are surgical instruments regardless of
the body part with which they come into
contact, in which case they are classified
as class 1;
"
Or. en
Amendment 822
Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point a a (new)
Regulation (EU) 2017/746
Annex IX – Section 2.4
Text proposed by the Commission Amendment
(aa) Section 2.4 is replaced by the
following:
"2.4. The manufacturer in question shall
inform the notified body which approved
the quality management system of any
plan for substantial changes to the quality
management system or substantial
changes to the device range included in
the certificate, including the addition of a
new product category or a new generic
device group to the scope of the
certificate. The notified body shall assess
the proposed changes, determine whether
additional audits or documentary reviews
are necessary, and verify whether the
quality management system continues to
meet the requirements referred to in
Section 2.2 after those changes. It shall
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notify the manufacturer of its decision
which shall contain the conclusions of the
assessment, and where applicable, the
conclusions of any additional audits or
reviews. The approval of any substantial
change to the quality management system
or to the device-range covered by the
certificate shall take the form of a
supplement to the EU quality
management system certificate."
Or. en
Justification
Clarifies the scope of information to be provided and that additional audits or reviews are
required only where necessary, reducing unnecessary administrative burden.
Amendment 823
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point c
Regulation (EU) 2017/745
Annex IX – Section 3.3 – subparagraph 1
Text proposed by the Commission Amendment
Notified bodies shall periodically carry out
appropriate audits and assessments to make
sure that the manufacturer in question
applies the approved quality management
system and the post-market surveillance
plan. Those audits and assessments shall
include audits on the premises of the
manufacturer and, if appropriate, of the
manufacturer's suppliers and/or
subcontractors. On justified grounds, the
audit may be conducted remotely instead
of on-site. The notified body shall, where
necessary, carry out or ask for tests in order
to check that the quality management
system is working properly. It shall provide
the manufacturer with a surveillance audit
report and, if a test has been carried out,
with a test report.
Notified bodies shall periodically carry out
appropriate audits and assessments to make
sure that the manufacturer in question
applies the approved quality management
system and the post-market surveillance
plan. Those audits and assessments shall
include audits on the premises of the
manufacturer and, if appropriate, of the
manufacturer's suppliers and/or
subcontractors. In exceptional and duly
justified cases, the audit may be conducted
remotely instead of on-site. The reasons
justifying the remote audit shall be
documented in the audit report. The
notified body shall, where necessary, carry
out or ask for tests in order to check that
the quality management system is working
properly. It shall provide the manufacturer
with a surveillance audit report and, if a
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test has been carried out, with a test report.
Or. en
Amendment 824
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point c
Regulation (EU) 2017/745
Annex IX – Section 3.3 – subparagraph 2
Text proposed by the Commission Amendment
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns resulting from
data from post-market surveillance or
vigilance, the notified body shall carry out
the surveillance audits and assessments
only once every 24 months.;
The notified body shall carry out the
surveillance audits and assessments at least
once every 12 months. However, where
justified in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns arising from
post-market surveillance or vigilance data,
the notified body may carry out the
surveillance audits and assessments once
every 24 months. Notwithstanding the
second sentence, the notified body shall
carry out a surveillance audit or
assessment at an earlier stage where there
are reasonable grounds to believe that the
safety or performance of the device may
be adversely affected.
Or. en
Amendment 825
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point d – point i
Regulation (EU) 2017/745
Annex IX – Section 3.4 – paragraph 1
Text proposed by the Commission Amendment
The notified body shall perform short-
notice or unannounced audits on the site of
The notified body shall perform random
short-notice or unannounced audits on the
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the manufacturer and, where appropriate,
of the manufacturer's suppliers and/or
subcontractors when justified based on
concerns related to post-market
surveillance or vigilance data or at the
request of a competent authority. The
short-notice or unannounced audit may be
combined with the periodic surveillance
assessment referred to in Section 3.3. or be
performed in addition to that surveillance
assessment.;
site of the manufacturer at least once every
five years and, where appropriate, of the
manufacturer's suppliers and/or
subcontractors The short-notice or
unannounced audit may be combined with
the periodic surveillance assessment
referred to in Section 3.3. or be performed
in addition to that surveillance assessment.
Where justified on the basis of concerns
arising from post-market surveillance or
vigilance data or at the request of a
competent authority, the notified body
may carry out additional random short-
notice or unannounced audits within that
five-year period.
Or. en
Amendment 826
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point d – point ii
Regulation (EU) 2017/745
Annex IX – Section 3.4 – paragraph 2
Text proposed by the Commission Amendment
Within the context of such unannounced
on-site audits, the notified body may test
an adequate sample of the devices
produced or an adequate sample from the
manufacturing process to verify that the
manufactured device is in conformity with
the technical documentation, with the
exception of the devices referred to in the
second subparagraph of Article 52(8).;
Within the context of such unannounced
on-site audits, the notified body shall,
where appropriate, test an adequate
sample of the devices produced or an
adequate sample from the manufacturing
process to verify that the manufactured
device is in conformity with the technical
documentation, with the exception of the
devices referred to in the second
subparagraph of Article 52(8).;
Or. en
Amendment 827
Tiemo Wölken
Proposal for a regulation
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Annex I – paragraph 1 – point 7 – point e
Regulation (EU) 2017/745
Annex IX – Section 3.5
Text proposed by the Commission Amendment
In the case of class III devices, with the
exception of well-established technology
devices, the surveillance assessment shall
also include a test of the approved parts
and/or materials that are essential for the
integrity of the device, including, where
appropriate, a check that the quantities of
produced or purchased parts and/or
materials correspond to the quantities of
finished devices.;
In the case of class III devices the
surveillance assessment shall also include a
test of the approved parts and/or materials
that are essential for the integrity of the
device, including, where appropriate, a
check that the quantities of produced or
purchased parts and/or materials
correspond to the quantities of finished
devices.;
Or. en
Amendment 828
Viktória Ferenc, Ondřej Knotek, Laurent Castillo, Valérie Deloge
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point k a (new)
Regulation (EU) 2017/745
Annex IX – Section 4.10a (new)
Text proposed by the Commission Amendment
(ka) Changes to the approved device
shall require approval from the notified
body which issued the EU technical
documentation assessment certificate
where such changes could adversely
affect the safety and performance of the
device or the conditions prescribed for use
of the device. Where the manufacturer
plans to introduce or has introduced any
of the abovementioned substantial
changes it shall inform the notified body
which issued the EU technical
documentation assessment certificate
thereof.
The notified body shall assess the
substantial changes and decide whether
the changes require a new conformity
assessment in accordance with Article 52
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or whether they could be addressed by
means of a supplement to the EU
technical documentation assessment
certificate. In the latter case, the notified
body shall determine if the changes shall
be assessed prior to or after
implementation, notify the manufacturer
of its decision and, where the changes are
approved, provide it with a supplement to
the EU technical documentation
assessment certificate.
Or. en
Amendment 829
Ruggero Razza, Michele Picaro
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point p a (new)
Regulation (EU) 2017/745
Annex IX – Section 5.4 – point a
Present text Amendment
Annex IX, Section 5.4 (a) ‘Annex IX, Section 5.4 (a)
(a) The quality and safety of devices that
are composed of substances or of
combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by, or locally
dispersed in, the human body, shall be
verified where applicable and only in
respect of the requirements not covered by
this Regulation, in accordance with the
relevant requirements laid down in
Annex I to Directive 2001/83/EC for the
evaluation of absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances and
potential for adverse reactions.
(a) The quality and safety of devices that
are composed of substances or of
combinations of substances that are
intended to be introduced into the human
body via a body orifice or applied to the
skin and that are absorbed by, or locally
dispersed in, the human body, shall also be
assessed where applicable for aspects
relating to the absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances,
and the potential for adverse reactions,
taking into account the state of the art
and the characteristics of the substance or
combination of substances.
Or. it
((EU) 2017/745)
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Justification
This amendment modifies a provision that has remained unchanged in the Commission
proposal, removing the automatic reference to requirements designed for medicinal products.
However, a rigorous assessment of the relevant safety aspects remains ensured, through
criteria specifically adapted to medical devices and their characteristics.
Amendment 830
Letizia Moratti, Dolors Montserrat, Elena Nevado del Campo
Proposal for a regulation
Annex I – paragraph 1 – point 7 – point p a (new)
Regulation (EU) 2017/745
Annex IX – Section 5.4 – point a
Present text Amendment
The quality and safety of devices that are
composed of substances or of combinations
of substances that are intended to be
introduced into the human body via a body
orifice or applied to the skin and that are
absorbed by, or locally dispersed in, the
human body, shall be verified where
applicable only in respect of the
requirements not covered by this
Regulation, in accordance with the
relevant requirements laid down in Annex
I to Directive 2001/83/EC for the
evaluation of absorption, distribution,
metabolism, excretion, local tolerance,
toxicity, interaction with other devices,
medicinal products or other substances and
potential for adverse reactions.
"The quality and safety of devices that are
composed of substances or of combinations
of substances that are intended to be
introduced into the human body via a body
orifice or applied to the skin and that are
absorbed by, or locally dispersed in, the
human body, shall be verified where
applicable for the matter referring to
absorption, distribution, metabolism,
excretion, local tolerance, toxicity,
interaction with other devices, medicinal
products or other substances and potential
for adverse reactions and having regard to
the state of the art and to the
characteristics of the substance(s)
concerned."
Or. en
(2017/745)
Justification
Justification
Removing the reference to Directive 2001/83/EC (the legislation governing medicinal
products) eliminates an unnecessary source of regulatory uncertainty. Medical devices and
medicinal products operate through different mechanisms and are subject to separate
regulatory frameworks. It is therefore neither appropriate nor scientifically justified to
require medical device manufacturers to address the aspects set out in essential requirement
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12.2 using an approach developed for medicinal products, as this may unnecessarily hinder
innovation and delay access to products that meet emerging healthcare needs.
To maintain a high level of patient safety, the amendment preserves the manufacturer's
obligation to rigorously assess those aspects through an approach specifically designed for
medical devices, ensuring equivalent safety outcomes. This is consistent with the initiative’s
main objectives of simplification, legal certainty, and regulatory coherence for medical
devices within the EU.
Amendment 831
Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 9 – point c
Regulation (EU) 2017/745
Annex XI – Section 7 – paragraph 2
Text proposed by the Commission Amendment
In the case of class III devices, other than
well-established technology devices,
surveillance shall also include a check that
the quantities of produced or purchased
raw material or crucial components
approved for the type correspond to the
quantities of finished devices.;
In the case of class III devices, surveillance
shall also include a check that the
quantities of produced or purchased raw
material or crucial components approved
for the type correspond to the quantities of
finished devices.;
Or. en
Amendment 832
Ondřej Dostál
Proposal for a regulation
Annex I – paragraph 1 – point 12 – point a – point ii
Regulation (EU) 2017/745
Annex XIV – Section 1 – point a – paragraph 2
Text proposed by the Commission Amendment
Points (b) to (e) shall not apply to devices
for which confirmation of safety and
performance based on clinical data is not
deemed appropriate in accordance with
Article 61(10).;
Points (b) to (e) shall not apply to devices
for which confirmation of safety and
performance based on clinical data is not
deemed appropriate in accordance with
Article 61(10).;
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Or. en
Justification
"Shall" in Commission proposal is stronger wording than "may" in amendment 127.
Amendment 833
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Annex I – paragraph 1 – point 12 – point b
Regulation (EU) 2017/745
Annex XIV – Section 3
Text proposed by the Commission Amendment
(b) in Section 3, the second and third
indents are replaced by the following:
deleted
‘- Biological: the device uses the same or
similar materials or substances in contact
with the same human tissues or body
fluids for a similar kind and duration of
contact and similar release characteristics
of substances, including degradation
products and leachables;
– Clinical: the device is used for the same
or similar clinical condition or purpose,
including similar severity and stage of
disease, at the same site in the body, in a
similar population, including as regards
age, anatomy and physiology; has the
same kind of user; has similar relevant
critical performance in view of the
expected clinical effect for a specific
intended purpose.;’
Or. en
Justification
Maintain current language as concerns equivalence. Equivalence should be accepted in the
'same' conditions, not 'same or similar'
Amendment 834
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Tiemo Wölken
Proposal for a regulation
Annex I – paragraph 1 – point 12 – point b
Regulation (EU) 2017/745
Annex XIV – Section 3
Text proposed by the Commission Amendment
(b) in Section 3, the second and third
indents are replaced by the following:
deleted
‘- Biological: the device uses the same or
similar materials or substances in contact
with the same human tissues or body
fluids for a similar kind and duration of
contact and similar release characteristics
of substances, including degradation
products and leachables;
– Clinical: the device is used for the same
or similar clinical condition or purpose,
including similar severity and stage of
disease, at the same site in the body, in a
similar population, including as regards
age, anatomy and physiology; has the
same kind of user; has similar relevant
critical performance in view of the
expected clinical effect for a specific
intended purpose.;’
Or. en
Amendment 835
Valentina Palmisano
Proposal for a regulation
Annex I – paragraph 1 – point 12 – point b
Regulation (EU) 2017/745
Annex XIV – Section 3
Text proposed by the Commission Amendment
(b) in Section 3, the second and third
indents are replaced by the following:
deleted
‘- Biological: the device uses the same or
similar materials or substances in contact
with the same human tissues or body
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fluids for a similar kind and duration of
contact and similar release characteristics
of substances, including degradation
products and leachables;
– Clinical: the device is used for the same
or similar clinical condition or purpose,
including similar severity and stage of
disease, at the same site in the body, in a
similar population, including as regards
age, anatomy and physiology; has the
same kind of user; has similar relevant
critical performance in view of the
expected clinical effect for a specific
intended purpose.;’
Or. en
Amendment 836
Tiemo Wölken
Proposal for a regulation
Annex I a (new)
Regulation (EU) 2017/745
Annex XVIIa (new)
Text proposed by the Commission Amendment
ANNEX XVIII
Minimum information to be provided in
the notification of an anticipated
interruption or discontinuation of the
supply of certain devices.
For the purposes of Article 10a, the
notification shall contain at least the
following information:
1. Administrative information
- Name of the national competent
authority (NCA) to which the notification
is submitted.
- Type of notification: initial notification;
additional information (voluntary);
follow-up information (voluntary).
- Date of notification. Reference number
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assigned by the manufacturer (if any).
- Reference number assigned by the
national competent authority (where
applicable).
2. Information on the submitter of the
notification
- Status of submitter: manufacturer;
authorised representative (where
mandated to act on behalf of the
manufacturer); other entity (acting on
behalf of the manufacturer).
3. Manufacturer information
- Manufacturer organisation name.
- Single Registration Number (SRN).
Where the SRN is provided and the
manufacturer is registered in
EUDAMED, completion of the remaining
fields in this Section shall not be required.
- Contact details (address, telephone
number and email address).
4. Authorised representative information
(where applicable)
- Authorised representative organisation
name.
- Single Registration Number (SRN).
Where the SRN is provided and the
authorised representative is registered in
EUDAMED, completion of the remaining
fields in this Section shall not be required.
- Contact details.
5. Other entity (where applicable)
- Organisation completing the notification
on behalf of the manufacturer.
- Contact details (address, telephone
number and email address).
6. Device information
- Risk class.
- Device identification:
- UDI-DI/EUDAMED-DI (where
applicable); Basic UDI-DI/EUDAMED-
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EN
DI (where applicable).
- Where the device is not registered in
EUDAMED or does not have a UDI-DI or
EUDAMED-DI, provide: model;
catalogue/reference number;
nomenclature system; nomenclature code;
nomenclature text;
commercial/brand/common name;
intended purpose according to the
instructions for use (or attach the IFU,
voluntarily).
7. Description of the anticipated
interruption or discontinuation of supply
- Interruption or discontinuation.
- Expected start date and expected end
date by Member State.
- Member States where the device is
marketed.
- Member States affected. Information on
notifications sent pursuant to Article
10a(1), including dates of notification to
health institutions and healthcare
professionals, authorised representatives
(where applicable), importers (where
applicable) and distributors.
- Reason for the anticipated interruption
or discontinuation of supply, including
one or more of the following categories:
manufacturing issues; quality or safety
issues; distribution or supply-chain
issues; unexpected increase in demand;
commercial reasons; regulatory or
conformity-assessment issues; exceptional
circumstances or force majeure; any
other reason (to be specified).
- Assessment of the impact of the
anticipated interruption or
discontinuation of supply (where
available), including whether the device is
life-sustaining or life-saving, intended for
a specific patient population, has
equivalent alternatives available, affects
access to treatment, or has a significant
market share in one or more Member
States.
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8. Additional information relating to the
anticipated interruption or
discontinuation of supply (voluntary)
- Possible mitigation measures.
- Possibility for redistribution of Union or
global stock. Availability of an equivalent
or alternative device intended for the
same intended purpose.
- Information on remaining inventory or
available stock within the Union, where
known.
8.1. Detailed categories for reasons
(Section 7)
8.1.1 Manufacturing issues
- Unavailability of components, materials
or raw materials.
- Unavailability of substances of human
or animal origin, where applicable.
- Failure or unavailability of
manufacturing equipment or production
lines.
- Delays in manufacturing, testing, final
inspection or release of finished devices.
- Non-compliance of the manufacturer’s
quality management system. Transfer,
closure or temporary suspension of a
manufacturing site.
- Manufacturing capacity constraints.
- Failure, insolvency or disruption
affecting a critical supplier or
subcontractor.
- Other manufacturing issues.
8.1.2. Quality or safety issues
Non-conformity or quality defects
affecting the device.
Failure of the device to achieve its
intended performance.
Serious incidents or an increased trend in
incidents.
Field safety corrective actions.
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Withdrawals, recalls or restrictions on the
making available of the device.
Suspension, restriction or termination of
production or supply as a preventive or
corrective measure. Cybersecurity
vulnerabilities affecting, or potentially
affecting, the safety or performance of the
device. Other quality or safety issues.
8.1.3. Distribution or supply-chain issues
- Export restrictions or prohibitions.
- Import or export delays.
- Customs clearance delays.
- Transport, storage or logistics
disruptions.
- Disruption affecting an importer,
distributor, authorised representative or
logistics provider.
- Shortage or unavailability of packaging,
labelling or other materials necessary for
the supply of the device.
- Other distribution or supply-chain
issues.
8.1.4. Unexpected increase in demand
- Public-health emergencies. Seasonal,
epidemiological or other significant
changes in clinical demand.
- Changes in clinical practice or patterns
of use.
- Unavailability or reduced availability of
equivalent, alternative or competing
devices.
- Unexpected increase in orders or
consumption.
- Other circumstances resulting in
increased demand.
8.1.5. Commercial reasons
- Change in the manufacturer’s
commercial or business strategy.
- Discontinuation of a device, device
model, product line or commercial
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activity.
- Lack of commercial viability.
- Insolvency, restructuring, merger,
acquisition or cessation of activities
affecting the manufacturer or a critical
supplier.
- Termination of contractual
arrangements with a supplier,
subcontractor, importer or distributor.
- Other commercial reasons.
8.1.6. Regulatory or conformity-
assessment issues
- Delay in the conformity-assessment
procedure.
- Delay in the issuance, renewal or
amendment of a certificate.
- Expiry, suspension, restriction or
withdrawal of a certificate.
- Termination or suspension of the
contractual relationship with a notified
body. Lack of notified-body capacity.
- Changes necessary to maintain
compliance with this Regulation.
- Delay in implementing corrective or
preventive measures required by a
competent authority or notified body.
- Other regulatory or conformity-
assessment issues.
8.1.7. Exceptional circumstances or force
majeure
- Natural disasters.
- Fire, flood or other major damage to
manufacturing or storage facilities.
- Armed conflict, civil unrest or sanctions.
- Pandemics or other public-health
emergencies.
- Disruption to energy supplies,
communications systems or other critical
infrastructure.
- Other exceptional circumstances beyond
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the manufacturer’s reasonable control.
8.1.8. Any other reason
- Any other reason, which shall be
specified.
Or. en
Amendment 837
Adam Jarubas
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point a a (new)
Regulation (EU) 2017/746
Annex I – Sections 16.4a (new) and 16.4b (new)
Text proposed by the Commission Amendment
(aa) the following Sections 16.5 and
16.6 are added:
‘
16.5 Connected devices shall comply with
the essential cybersecurity requirements
set out in Annex I, Part I, point 2, letter
(a) to (l) of Regulation (EU) 2024/2847 of
the European Parliament and of the
Council, taking into consideration
benefit-risk ratio of the device and
intended user.
16.6 Manufacturer of connected devices
shall fulfil requirements specified in
Annex I, Part II of regulation mentioned
in paragraph 17.5.1.\
’
Or. en
Amendment 838
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point i
Regulation (EU) 2017/746
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Annex I – Section 20.1 – second sentence of the of the first paragraph
Text proposed by the Commission Amendment
Such information may appear on the device
itself, on the packaging or in the
instructions for use, taking into account the
following:;
Such information may appear on the device
itself, on the packaging or in the
instructions for use and shall, if the
manufacturer has a website, be made
available and kept up to date on the
website taking into account the following:;
Or. en
Amendment 839
Aurelijus Veryga
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point iv
Regulation (EU) 2017/746
Annex I – Section 20.1 – point f
Text proposed by the Commission Amendment
(f) When the device is intended for
professional use only, instructions for use
may be provided to the user in non-paper
format (e.g. electronic).;
(f) Instructions for use may be
provided to the user in non-paper format
such as electronic format. Users shall
have the possibility to obtain instructions
for use in paper format upon request.;
Or. en
Amendment 840
Viktória Ferenc, Ondřej Knotek
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point iv
Regulation (EU) 2017/746
Annex I – Section 20.1 – point f
Text proposed by the Commission Amendment
(f) When the device is intended for
professional use only, instructions for use
may be provided to the user in non-paper
format (e.g. electronic).;
(f) Instructions for use may be
provided to the user in non-paper format
such as electronic format. Users shall
have the possibility to obtain instructions
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for use in paper format upon request.
Or. en
Justification
The proposed amendment promotes the use of electronic instructions for use and other non-
paper formats, which can improve access to the most current information, support
digitalisation and reduce unnecessary administrative burden. At the same time, it ensures that
users retain the ability to request and receive instructions in paper format where needed,
thereby safeguarding accessibility, inclusiveness and user choice. The amendment therefore
combines flexibility and innovation with appropriate user protections.
Amendment 841
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point v
Regulation (EU) 2017/746
Annex I – Section 20.1 – point k
Text proposed by the Commission Amendment
(k) For devices that are used
exclusively with a medicinal product in
accordance with Article 19 of [Proposal for
a Directive on the Union code relating to
medicinal products for human use, and
repealing Directive 2011/83/EC and
Directive 2009/35/EC] and packaged
together with a medicinal product, the
instructions for use may be included, where
needed, as part of the co-packaging of the
medicinal product with the device.
Moreover, the information on the label of
the device may be limited to the particulars
referred to in Section 20.2., points (a) and
(c), where, following agreement of the
competent authority responsible for the
authorisation of the medicinal product, the
following conditions are met:
(k) For devices that are used
exclusively with a medicinal product in
accordance with Article 19 of [Proposal for
a Directive on the Union code relating to
medicinal products for human use, and
repealing Directive 2011/83/EC and
Directive 2009/35/EC] and packaged
together with a medicinal product, the
instructions for use shall be included,
where needed, as part of the co-packaging
of the medicinal product with the device.
Moreover, the information on the label of
the device may be limited to the particulars
referred to in Section 20.2., points (a) and
(c), where, following agreement of the
competent authority responsible for the
authorisation of the medicinal product, the
following conditions are met:
Or. en
Amendment 842
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Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 1 – point b – point v
Regulation (EU) 2017/746
Annex I – Section 20.1 – point k – point ii a (new)
Text proposed by the Commission Amendment
(iia) electronic or digital means used to
provide access to the instructions for use
shall comply with Regulation (EU)
2016/679 and shall not permit the
identification, profiling or tracking of
patients beyond what is necessary for the
provision of that information.
Or. en
Amendment 843
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 4 – point a
Regulation (EU) 2017/746
Annex VI – Part B – point 29a (new)
Text proposed by the Commission Amendment
(30) identification number of the notified
body responsible for the conformity
assessment procedures set out in Article
48.
Or. en
Amendment 844
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point d
Regulation (EU) 2017/746
Annex VII – Section 1.2.9
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Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged.;
The requirements laid down in this
Section shall in no way preclude
exchanges of technical information,
regulatory guidance and scientific advice
between a notified body and a
manufacturer applying for conformity
assessment. The notified body shall have
documented procedures in place to offer
and carry out dialogues, including pre-
and post application, with the
manufacturer before and after an
application for conformity assessment is
lodged. In the context of the structured
dialogue, requests from the manufacturer
shall respect the independence, objectivity
and impartiality of the notified body. They
shall be limited to specific scientific,
technical or regulatory matters and shall
not seek advice on how to demonstrate or
achieve compliance with the requirements
of this Regulation. Responsibility for
ensuring compliance with those
requirements shall remain with the
manufacturer;
Or. en
Amendment 845
András Tivadar Kulja
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point d
Regulation (EU) 2017/746
Annex VII – Section 1.2.9
Text proposed by the Commission Amendment
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged.;
The notified body shall have documented
procedures in place to offer and carry out
dialogues with the manufacturer before and
after an application for conformity
assessment is lodged. These dialogues may
include structured and interactive
exchanges, including pre-submission
consultations, and consultations,
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throughout the conformity assessment
procedure.;
Or. en
Amendment 846
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point p
Regulation (EU) 2017/746
Annex VII – Section 4.2 – point a
Text proposed by the Commission Amendment
That description shall include which
languages are acceptable for submission of
documentation and for any related
correspondence and the modalities for
carrying out the dialogue referred to in
Section 1.2.9 of this Annex before an
application is lodged.;
publish a publicly available description of
the application procedure by which
manufacturers can obtain certification
from it. That description shall include the
languages acceptable for the submission of
documentation and any related
correspondence, and the modalities for
carrying out the dialogue referred to in
Section 1.2.9 of this Annex prior to the
submission of an application.
Or. en
Amendment 847
Andreas Glück, Stine Bosse, Billy Kelleher
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point r – point iii
Regulation (EU) 2017/745
Annex VII – Section 4.5.1
Text proposed by the Commission Amendment
– to leverage evidence from
previously performed assessments.;
– to leverage and, where
appropriate, rely on assessments, audit
results and evidence previously performed
by another notified body designated under
this Regulation and other certification
organisation; – to avoid unnecessary
duplication of conformity assessment
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activities already performed under this
Regulation; – to document and justify any
repetition of audits, inspections or
technical documentation assessments on
the basis of identified risks or significant
changes.
Or. en
Justification
Manufacturers are frequently required to repeat assessments already performed by another
notified body or recognised certification organisation, creating unnecessary administrative
burden and cost without improving patient safety. Requiring notified bodies to rely on existing
assessments, avoid duplication and justify any repetition focuses regulatory resources on
genuine risks and supports a more efficient, consistent conformity assessment system across
the Union.
Amendment 848
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point a
Regulation (EU) 2017/746
Annex IX – Section 2.3 – paragraph 3 – intent 1
Text proposed by the Commission Amendment
– for class B devices, one device; – for class B devices, at least one
representative device per category of
devices ;
Or. en
Amendment 849
Ignazio Roberto Marino
on behalf of the Verts/ALE Group
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point a
Regulation (EU) 2017/746
Annex IX – Section 2.3 – paragraph 3 – intent 2
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Text proposed by the Commission Amendment
– for class C devices, one device per
generic device group.
– for class C devices, at least one
representative device per generic device
group.
Or. en
Amendment 850
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point c
Regulation (EU) 2017/746
Annex IX – Section 3.3 – paragraph 1
Text proposed by the Commission Amendment
Notified bodies shall periodically carry out
appropriate audits and assessments to make
sure that the manufacturer in question
applies the approved quality management
system and the post-market surveillance
plan. Those audits and assessments shall
include audits on the premises of the
manufacturer and, if appropriate, of the
manufacturer's suppliers and/or
subcontractors. On justified grounds, the
audit may be conducted remotely instead
of on-site. The notified body shall, where
necessary, carry out or ask for tests in order
to check that the quality management
system is working properly. It shall provide
the manufacturer with a surveillance audit
report and, if a test has been carried out,
with a test report.
Notified bodies shall periodically carry out
appropriate audits and assessments to make
sure that the manufacturer in question
applies the approved quality management
system and the post-market surveillance
plan. Those audits and assessments shall
include audits on the premises of the
manufacturer and, if appropriate, of the
manufacturer's suppliers and/or
subcontractors. In exceptional and duly
justified cases, the audit may be conducted
remotely instead of on-site. The reasons
justifying the remote audit shall be
documented in the audit report. The
notified body shall, where necessary, carry
out or ask for tests in order to check that
the quality management system is working
properly. It shall provide the manufacturer
with a surveillance audit report and, if a
test has been carried out, with a test report.
Or. en
Amendment 851
Tiemo Wölken
Proposal for a regulation
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Annex II – paragraph 1 – point 6 – point c
Regulation (EU) 2017/746
Annex IX – Section 3.3 – paragraph 2
Text proposed by the Commission Amendment
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns resulting from
data from post-market surveillance or
vigilance, the notified body shall carry out
the surveillance audits and assessments
only once every 24 months.;
The notified body shall carry out the
surveillance audits and assessments at least
once every 12 months. However, where
justified in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns arising from
post-market surveillance or vigilance data,
the notified body may carry out the
surveillance audits and assessments once
every 24 months. Notwithstanding the
second sentence, the notified body shall
carry out a surveillance audit or
assessment at an earlier stage where there
are reasonable grounds to believe that the
safety or performance of the device may
be adversely affected.
Or. en
Amendment 852
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point c
Regulation (EU) 2017/745
Annex IX – Section 3.3 – paragraph 2
Text proposed by the Commission Amendment
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns resulting from
data from post-market surveillance or
vigilance, the notified body shall carry out
the surveillance audits and assessments
only once every 24 months.’;
The notified body shall carry out the
surveillance audits and assessments once
every 12 months. However, where justified
in light of the results of previous
surveillance audits and assessments, and in
the absence of any concerns resulting from
data from post-market surveillance or
vigilance, the notified body shall carry out
the surveillance audits and assessments
only once every 36 months.’;
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Or. fr
Amendment 853
Tiemo Wölken
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point d – point i
Regulation (EU) 2017/746
Annex IX – Section 3.4 – paragraph 1
Text proposed by the Commission Amendment
3.4. The notified body shall perform
audits, at short notice or unannounced, on
the site of the manufacturer and, where
appropriate, the site of the manufacturer’s
suppliers and/or subcontractors, when
justified based on concerns related to
post-market surveillance or vigilance data
or at the request of a competent authority.
The short-notice or unannounced audit may
be combined with the periodic surveillance
assessment referred to in Section 3.3. or be
performed in addition to that surveillance
assessment.;
3.4. The notified body shall perform
random audits, at short notice or
unannounced, on the site of the
manufacturer at least once every five years
and, where appropriate, the site of the
manufacturer’s suppliers and/or
subcontractors, . The short-notice or
unannounced audit may be combined with
the periodic surveillance assessment
referred to in Section 3.3. or be performed
in addition to that surveillance assessment.
Where justified on the basis of concerns
arising from post-market surveillance or
vigilance data or at the request of a
competent authority, the notified body
may carry out additional random audits,
at short notice or unannounced, within
that five-year period.
Or. en
Amendment 854
Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point f
Regulation (EU) 2017/745
Annex IX – Section 3.7.
Text proposed by the Commission Amendment
3.7. If the notified body finds a 3.7. If the notified body finds a
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divergence between the sample taken from
the devices produced or from the market
and the specifications laid down in the
technical documentation or the approved
design, it shall suspend or withdraw the
relevant certificate or impose conditions or
limitations on it.’;
divergence between the sample taken from
the devices produced or from the market
and the specifications laid down in the
technical documentation or the approved
design, it shall suspend or withdraw the
relevant certificate or impose conditions or
limitations on it, according to the risk the
divergence presents to the patient.’;
Or. fr
Amendment 855
Laurent Castillo, Marie-Luce Brasier-Clain, Valérie Deloge
Proposal for a regulation
Annex II – paragraph 1 – point 6 – point l a (new)
Regulation (EU) 2017/746
Annex IX – Section 4.10
Text proposed by the Commission Amendment
(la) Section 4.10 is amended as
follows:
Changes to the approved device shall
require approval from the notified body
which issued the EU technical
documentation assessment certificate
where such changes could significantly
affect the safety and performance of the
device or the conditions prescribed for use
of the device. Where the manufacturer
plans to introduce or has made any of the
above-mentioned changes, it shall inform
the notified body which issued the EU
technical documentation assessment
certificate thereof. The notified body shall
assess the planned significant changes
and decide whether they require a new
conformity assessment in accordance with
Article 52 or whether they could be
addressed by means of a supplement to
the EU technical documentation
assessment certificate. In the latter case,
the notified body shall assess the changes,
notify the manufacturer of its decision
and, where the changes are approved,
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provide it with a supplement to the EU
technical documentation assessment
certificate.
Or. fr
Amendment 856
Kateřina Konečná
Proposal for a regulation
Annex II – paragraph 1 – point 11 – point a – point iii a (new)
Regulation (EU) 2017/745
Annex XIV – Section 3
Text proposed by the Commission Amendment
(iiia) Part A - Section 3, Criteria for
claims of equivalence is amended as
follows:
Biological: the device uses the same
materials or substances in contact with
the same human tissues or body fluids for
a similar kind and duration of contact and
similar release characteristics of
substances, including degradation
products and leachables;
Clinical: the device is used for the same
clinical condition or purpose, including
similar severity and stage of disease, at
the same site in the body, in a similar
population, including as regards age,
anatomy and physiology; has the same
kind of user; has similar relevant critical
performance in view of the expected
clinical effect for a specific intended
purpose.’
Or. en
Amendment 857
Tiemo Wölken
Proposal for a regulation
Annex II a (new)
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Regulation (EU) 2017/746
ANNEX XVI new
Text proposed by the Commission Amendment
ANNEX XVI - Minimum information to
be provided in the notification of an
anticipated interruption or
discontinuation of the supply of certain in
vitro diagnostic medical devices
For the purposes of Article 10a, the
notification shall contain at least the
following information:
1. Administrative information
- Name of the national competent
authority (NCA) to which the notification
is submitted.
- Type of
notification: initial notification; additiona
l information (voluntary); follow-up
information (voluntary).
- Date of notification.
- Reference number assigned by the
manufacturer (if any).
- Reference number assigned by the
national competent authority (where
applicable).
2. Information on the submitter of the
notification
- Status of submitter:
manufacturer; authorised representative
(where mandated to act on behalf of the
manufacturer); other entity (acting on
behalf of the manufacturer).
3. Manufacturer
information Manufacturer organisation n
ame.
- Single Registration Number (SRN).
- Where the SRN is provided and the
manufacturer is registered in
EUDAMED, completion of the remaining
fields in this Section shall not
be required.
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- Contact details (address,
telephone number and email address).
4. Authorised representative information
(where applicable)
-
Authorised representative organisation na
me.
- Single Registration Number (SRN).
Where the SRN is provided and
the authorised representative is registered
in EUDAMED, completion of the
remaining fields in this Section shall not
be required.
- Contact details.
5. Other entity (where applicable)
- Organisation completing the notification
on behalf of the manufacturer.
- Contact details (address,
telephone number and email address).
6. Device information
Risk class.
- Device identification: UDI-
DI/EUDAMED-DI (where applicable);
Basic UDI-DI/EUDAMED-DI
(where applicable).
- Where the device is not registered in
EUDAMED or does not have a UDI-DI or
EUDAMED-DI, provide: model;
catalogue/reference number;
nomenclature system; nomenclature code;
nomenclature text; commercial
name/brand name/common name;
intended purpose according to the
instructions for use (or attach the
instructions for use, voluntarily).
7. Description of
the anticipated interruption or
discontinuation of supply
- Interruption or discontinuation.
- Expected start date and expected end
date by Member State.
- Member States where the in vitro
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diagnostic medical device is marketed.
- Member States affected.
- Information on notifications
sent pursuant to Article 10a(1), including
dates of notification to health institutions,
laboratories, healthcare
professionals, authorised representatives
(where applicable), importers (where
applicable) and distributors.
- Reason for the anticipated interruption
or discontinuation of supply, including
one or more of the categories set out
below.
- Assessment of the impact of the
anticipated interruption or
discontinuation of supply (where
available), including whether the device is
essential for diagnosis, screening,
monitoring, prognosis, prediction or
companion diagnostics; intended for a
specific patient population; has equivalent
or alternative devices available; affects
access to diagnosis or patient
management; or has a significant market
share in one or more Member States.
Detailed categories for reasons
7.1. Manufacturing issues
- Unavailability of
components, materials or raw materials.
- Unavailability of substances of human
or animal origin, where applicable.
- Failure or unavailability of
manufacturing equipment or production
lines.
- Delays in manufacturing, testing,
final inspection or release of finished
devices.
- Non-compliance of the manufacturer's
quality management system.
- Transfer, closure or temporary
suspension of a manufacturing site.
- Manufacturing capacity constraints.
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- Failure, insolvency or disruption
affecting a critical supplier or
subcontractor.
- Other manufacturing issues.
7.2. Quality or safety issues
- Non-conformity or quality
defects affecting the device.
- Failure of the device to achieve its
intended performance.
- Serious incidents or an increased trend
in incidents.
- Field safety corrective actions.
- Withdrawals, recalls or restrictions on
the making available of the device.
- Suspension, restriction or termination of
production or supply as a preventive or
corrective measure.
- Cybersecurity vulnerabilities affecting,
or potentially affecting, the
safety, security or performance of the
device.
- Other quality or safety issues.
7.3. Distribution or supply-chain issues
- Export restrictions or prohibitions.
- Import or export delays.
- Customs clearance delays.
-
Transport, storage or logistics disruptions.
- Disruption affecting an importer,
distributor, authorised representative
or logistics provider.
- Shortage or unavailability of
packaging, labelling or other materials
necessary for the supply of the device.
- Other distribution or supply-
chain issues.
7.4. Unexpected increase in demand
- Public-health emergencies.
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- Disease outbreaks or epidemiological
events.
- Changes in clinical or laboratory testing
practices.
- Unavailability or reduced availability of
equivalent, alternative or competing
devices.
- Unexpected increase in testing demand
or orders.
- Other circumstances resulting in
increased demand.
7.5. Commercial reasons
- Change in the manufacturer's
commercial or business strategy.
- Discontinuation of a device, device
family, product line or commercial
activity.
- Lack of commercial
viability. Insolvency, restructuring,
merger, acquisition or cessation of
activities affecting the manufacturer or a
critical supplier.
- Termination of contractual
arrangements with a supplier,
subcontractor, importer or distributor.
- Other commercial reasons.
7.6. Regulatory or conformity-assessment
issues
- Delay in the conformity-
assessment procedure.
- Delay in the issuance, renewal or
amendment of a certificate.
- Expiry, suspension, restriction or
withdrawal of a certificate.
- Termination or suspension of the
contractual relationship with a notified
body.
- Lack of notified-body capacity.
- Changes necessary
to maintain compliance with this
Regulation.
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- Delay in implementing corrective or
preventive measures required by a
competent authority or notified body.
- Other regulatory or conformity-
assessment issues.
7.7. Exceptional circumstances or force
majeure
- Natural disasters.
- Fire, flood or other major damage to
manufacturing or storage facilities.
- Armed conflict, civil unrest or
sanctions.
- Pandemics or other public-
health emergencies.
- Disruption to energy supplies,
communications systems or other critical
infrastructure.
- Other exceptional circumstances beyond
the manufacturer's reasonable control.
7.8. Any other reason
- Any other reason, which shall be
specified.
8. Additional information relating to
the anticipated interruption or
discontinuation of supply (voluntary)
- Possible mitigation measures.
- Possibility for redistribution of Union or
global stock.
- Availability of an equivalent or
alternative in vitro diagnostic medical
device intended for the same intended
purpose.
- Information on remaining inventory or
available stock within the Union, where
known.
Or. en
24.08.2026
Datei
PD
