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Pharma Deutschland e. V.
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1
Position on the Amendments on the Proposal for a Regulation
amending Regulation (EU) 2017/745 as regards the simplification and
reduction of regulatory burdens for medical devices (COM(2025) 1023
final)
Date: 11 September 2026
Pharma Deutschland e.V. represents the interests of the pharmaceutical and medical device
industry at both federal and state levels to politics, authorities, and institutions in the healthcare
sector. With around 400 member companies, it is the largest association in the pharmaceutical
and medical device sector. The political advocacy and member support extend to the area of
prescription and non-prescription drugs as well as medical devices, such as medical apps and
digital health applications.
General Support for the EU Proposal to Simplify and Streamline Medical Device Regulation
Pharma Deutschland welcomes the European Parliaments’ initiative to simplify the EU regulatory
framework for medical devices and to enhance the competitiveness of the European medical
device sector within the internal market and at global level.
Most of the amendments proposed in the Draft Report of the Committee on Public Health of the
European Parliament are well suited to achieve these objectives. These amendments should
therefore be retained. In particular, this applies to:
• Digitalisation – enabling the broader use of electronic instructions for use (eIFU)
• Simplification for products intended for professional users – allowing certain
information to be provided in English
• Increased transparency and stakeholder involvement – strengthening the participation
of manufacturers, notified bodies and industry associations in various regulatory
procedures
• Greater legal clarity – revising classification Rule 14 for medical devices incorporating a
medicinal substance and classification Rule 21 for substance-based medical device
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Analysis of the Amendments submitted
The following analysis focuses on those proposed changes that are of greatest relevance to
Pharma Deutschland members, in particular manufacturers of substance-based medical
devices, dental medical devices and software. Pharma Deutschland has analysed the
amendments relating to the following provisions:
• Recitals 11, 11a and 11b
• Recital 39
• Article 2(72) – Definitions - well-established technology devices
• Article 4 – Regulatory Status of Products
• Article 4a – Opinion on and determination of the regulatory status of a product
• Article 18(3) – Implant card and information to be supplied to the patient with an
implanted device
• Article 61(5) – Clinical evaluation
• Article 86(1) – Periodic safety update report (PSUR)
• Article 94 – Evaluation of devices suspected of presenting an unacceptable risk or
other non-compliance
• Article 106b – Support by the EMA
• Annex VIII – Classification Rules
- Rules 6 and 7
- Rule 11
- Rule 14
- Rule 21
• Annex XIV Part A – Clinical evaluation
The analysis is colour-coded: green for amendments fully supported by Pharma Deutschland,
yellow for amendments partially supported by Pharma Deutschland, and red for amendments
that Pharma Deutschland does not support.
Need for further improvements and addressing unresolved issues under the MDR
Furthermore, several important issues affecting Pharma Deutschland members have not been
addressed either in the Draft Report or in the submitted amendments. Pharma Deutschland
therefore recommends further improvements with regard to the following provisions:
• Article 1(8) – Subject matter and scope
• Article 2(7) – Definitions - ‘generic device group’
• Article 60 – Certificate of free sale
• Article 97 – Other non-compliance
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▪ Recitals
Recitals 11, 11a and 11b
The European Commission seeks, through its proposed Recital 11, to enhance legal certainty and
safeguard the principle of the free movement of goods. However, these objectives cannot be fully
achieved through the coordination mechanism proposed by the Commission. The Draft Report
proposes an amendment to Recital 11 (Amendment 3), which Pharma Deutschland fully
supports. It clarifies that decisions on the regulatory status of products should be taken by the
competent authority of the Member State in which the manufacturer has its registered place of
business. This approach enhances legal certainty, reduces the risk of divergent assessments by
different competent authorities and promotes a more predictable regulatory framework. One
additional amendment has been submitted in relation to Recital 11 (Amendment 141).
Furthermore, the Draft Report introduces a new Recital 11a, aimed at avoiding duplicative or
unnecessary layers of regulatory oversight and ensuring that the coordination mechanism is not
intended to operate as a parallel post-certification review process. Three further amendments
pursue a similar objective (Amendments 142, 143 and 144).
Amendment 141 Recital 11
Proposed by Sirpa Pietikäinen Position of Pharma Deutschland
(11) To ensure legal certainty and to safeguard the
principle of free movement of goods, the
coordination mechanism between national
competent authorities for decisions on the
regulatory status of a product and on the
classification of a device, should be
streamlined and, where appropriate, involve
external expertise from an expert panel,
supported by the European Medicines Agency
(EMA). The decision on the regulatory status,
however, should remain with the national
authorities or, where appropriate, be with the
Commission acting through implementing
acts.
Reject Amendment 141
Justification
It is essential that decisions on the regulatory status of products remain with the competent authority
of the Member State in which the manufacturer has its registered place of business. This approach
supports legal certainty, regulatory consistency and the principle of subsidiarity. Amendment 3 of the
Draft Report considers this aspect.
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The proposed wording in Amendment 141 could be interpreted as extending the role of the Commission
in regulatory status determinations. However, the Commission should only become involved in
exceptional cases and on the basis of a substantiated request from a Member State following an expert
panel opinion. Such an approach makes the best use of the Commission's resources.
Amendment 142 Recital 11a
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
(11a) Where a device has successfully passed
the conformity assessment undertaken with
the involvement of a notified body and has
been CE marked in accordance with Article
20, the coordination activities under Article
4 should not serve as a subsequent
supplementary regulatory review, as this
may undermine legal certainty and the
predictability of the certification process.
Accordingly, coordination activities for the
products in question should be limited to
cases in which there is well-founded
evidence that, on the basis of its regulatory
status, the product poses an unacceptable
risk pursuant to Article 94(a).
Partially accept Amendment 142
Justification
The first part of Amendment 142 is supported. A device that has successfully undergone a conformity
assessment involving a notified body and has been CE-marked in accordance with Article 20 should
benefit from a high degree of regulatory certainty.
The coordination mechanism under Article 4 should not operate as a parallel post-certification
review process. A re-examination of the regulatory status of a CE-marked device after certification
would undermine the predictability of the conformity assessment system, create uncertainty for
manufacturers and weaken confidence in CE certificates and notified body assessments. Coordination
activities concerning CE-marked devices should therefore be limited to exceptional cases.
The first part of the amendment strengthens legal certainty, safeguards the principle of the free
movement of goods and avoids unnecessary duplication of regulatory oversight. Amendment 4 of the
Draft Report and Amendments 142 and 143 are substantively aligned and pursue the same objective
of ensuring that the coordination mechanism does not operate as a supplementary review of regulatory
decisions already supported by a conformity assessment and CE marking. The first part of one of
these amendments should be accepted.
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The second part of Amendment 142 should be deleted. The proposed limitation of coordination
activities to cases in which there is well-founded evidence that a product poses an unacceptable risk
pursuant to Article 94(a) is not appropriate. Unacceptable risks are already addressed under Article
95. Moreover, the regulatory status of a product does not in itself constitute an unacceptable risk within
the meaning of Article 94(a), as further explained in the justification concerning Amendment 273. In
principle, national authorities are empowered to question the regulatory status of CE-marked products
as part of market surveillance, irrespective of the product risk. However, any restrictions on the free
movement of such products require an objectively sound decision-making process in accordance with
Articles 4 and 4a. The second part of Amendment 142 should consequently be deleted.
Amendment 143 Recital 11a
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
(11a) For a device that has undergone the
conformity assessment involving a notified
body and that bear the CE marking in
accordance with Article 20, the coordination
mechanism laid down in Article 4 should not
operate as a parallel ex-post regulatory
review capable of undermining legal
certainty and the predictability of
certification. Accordingly, use of the
coordination mechanism for such products
should be confined to cases where there is
substantiated evidence that, on account of
its regulatory qualification, the product
presents an unacceptable risk within the
meaning of Article 94(a).
Partially accept Amendment 143
Justification
A device that has successfully undergone a conformity assessment involving a notified body and has
been CE-marked in accordance with Article 20 should benefit from a high degree of regulatory certainty.
The coordination mechanism under Article 4 should not operate as a parallel post-certification
review process. A re-examination of the regulatory status of a CE-marked device after certification
would undermine the predictability of the conformity assessment system, create uncertainty for
manufacturers and weaken confidence in CE certificates and notified body assessments. Coordination
activities concerning CE-marked devices should therefore be limited to exceptional cases.
The first part of the amendment strengthens legal certainty, safeguards the principle of the free
movement of goods and avoids unnecessary duplication of regulatory oversight. Amendment 4 of the
Draft Report and Amendments 142 and 143 are substantively aligned and pursue the same objective
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of ensuring that the coordination mechanism does not operate as a supplementary review of regulatory
decisions already supported by a conformity assessment and CE marking. The first part of one of
these amendments should be accepted.
The second part of Amendment 143 should be deleted. The proposed limitation of coordination
activities to cases in which there is well-founded evidence that a product poses an unacceptable risk
pursuant to Article 94(a) is not appropriate. Unacceptable risks are already addressed under Article
95. Moreover, the regulatory status of a product does not in itself constitute an unacceptable risk within
the meaning of Article 94(a), as further explained in the justification concerning Amendment 273. In
principle, national authorities are empowered to question the regulatory status of CE-marked products
as part of market surveillance, irrespective of the product risk. However, any restrictions on the free
movement of such products require an objectively sound decision-making process in accordance with
Articles 4 and 4a. The second part of Amendment 143 should consequently be deleted.
Amendment 144 Recital 11b
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
(11b) Where a device has successfully passed
the conformity assessment undertaken with
the involvement of a notified body and has
been CE marked in accordance with Article
18, the coordination activities under Article
3 should not serve as a supplementary
regulatory review, as this may undermine
legal certainty and the predictability of the
certification process. Accordingly,
coordination activities for the products in
question should be limited to cases in which
there is well-founded evidence that, on the
basis of its regulatory status, the product
poses an unacceptable risk pursuant to
Article 89(a).
Reject Amendment 144
Justification
The proposed text contains incorrect references to MDR provisions.
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▪ Recitals
Recital 39
Recital 39 explains the rationale for the Commission's proposal to make the equivalence concept
more practical and workable under the MDR. In particular, it recognises that clinical data are often
available for equivalent devices and that the current requirement to obtain a contract with the
manufacturer of the equivalent device granting access to its technical documentation has proven
to be extremely difficult, if not impossible, to fulfil in practice.
Amendments 208 and 209 Recital 39
Proposed by Ignazio Roberto Marino on behalf
of the Verts/ALE Group and by Tiemo Wölken
Position of Pharma Deutschland
Deletion of Recital 39 Reject Amendments 208 and 209
Justification
The Commission's proposal seeks to address a well-recognised obstacle to the use of equivalence
while maintaining the requirement that equivalence must be scientifically demonstrated and that the
clinical evaluation must comply with the requirements of the MDR. Deleting the recital would remove
the policy justification for these important changes and could undermine the objective of improving the
practical applicability of the equivalence concept.
A more workable equivalence framework would facilitate the use of existing clinical evidence, reduce
unnecessary clinical investigations and administrative burdens, and avoid the generation of duplicative
clinical data where sufficient evidence is already available.
The retention of Recital 39 therefore supports a more proportionate and efficient regulatory framework
while maintaining a high level of patient safety. The proposed deletions should therefore be rejected.
Amendment 210 Recital 39
Proposed by Laurence Trochu Position of Pharma Deutschland
(39) Clinical data are often available for devices
that are equivalent to the device under
conformity assessment. In order to make the
conditions under which manufacturers can
claim equivalence more flexible, the
requirement in Regulation (EU) 2017/745 for a
contract with the manufacturer of the
equivalent device granting access to its
Accept Amendment 210
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technical documentation should therefore be
removed and the equivalence criteria be
adapted, without compromising the
competitiveness of the most innovative
manufacturers, who are making the effort to
be the first to produce clinical data.
Assessment data obtained under
Regulation (EU) 2021/2282 on health
technology assessment may itself be used
by manufacturers for their own (CE) marking
file.
Justification
While the Commission proposal aims to make the equivalence concept more practical by removing the
requirement to obtain access to a competitor's technical documentation, it is equally important to
ensure that this increased flexibility does not undermine incentives for innovation and clinical evidence
generation. Manufacturers that invest significant resources in generating clinical data should not be
placed at a competitive disadvantage compared with competitors relying on equivalence. The
proposed wording appropriately recognises the need to balance a more practical use of equivalence
with the protection of innovation and investment in clinical research.
Furthermore, the reference to assessment data generated under Regulation (EU) 2021/2282 on Health
Technology Assessment is welcomed. Where scientifically relevant and applicable, the use of such
data may help avoid unnecessary duplication of evidence generation and contribute to a more efficient
regulatory system.
The amendment therefore supports a proportionate application of the equivalence concept while
preserving incentives for innovation, facilitating the use of existing evidence and reducing unnecessary
regulatory burdens.
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▪ Definitions
Article 2(72)
The European Commission’s proposal introduces a new definition of the term “well-established
technology device” and removes the current list of products. This initiative is welcomed. However,
a limited clarification or minor amendment would still be necessary to ensure legal certainty and
consistent application. The Draft Report of the Committee on Public Health of the European
Parliament foresees cumulative conditions in the wording of the second criterion
(Amendment 13). The wording of the second part of this criterion (has a well-known safety history
and has not been associated with safety issues in the past) remains unclear and may lead to
divergent interpretations. Several amendments have been submitted on Article 2(72)
(Amendments 235 ff.).
Amendment 235 Article 2(72)
Proposed by Ignazio Roberto Marino Position of Pharma Deutschland
Deleted Article 2(72) Reject Amendment 235
Justification
The definition proposed by the European Commission is based on MDCG Guidance 2020-6. To provide
legal certainty for manufacturers, it is essential to establish clear criteria for well-established
technologies directly in the MDR.
From a practical perspective, it is not possible to create an exhaustive list of technologies that qualify
as "well-established". Medical devices are highly diverse and continuously evolving, making a
comprehensive list impracticable.
Well-established technologies are characterised by proven clinical performance and an established
safety profile. The current regulatory framework does not sufficiently reflect these characteristics.
Therefore, the regulatory simplifications introduced by the MDR should be available to all devices that
demonstrably meet the criteria of a well-established technology, irrespective of their risk class,
provided that clear and objective qualification criteria are maintained in the legislation.
Amendments 236 and 237 Article 2(72)
Proposed by Marie-Sophie Lanig, Angelika
Niebler and by Andreas Glück, Stine Bosse,
Billy Kelleher
Position of Pharma Deutschland
(a) it has simple, common and stable design Accept Amendments 236 and 237
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Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. “Simple design” lacks sufficient legal certainty.
Amendment 238 Article 2(72)
Proposed by Marie-Sophie Lanig, Angelika
Niebler
Position of Pharma Deutschland
(b) it has a well-known safety history and, as
defined by Article 87, has not been
associated with safety issues in the past;
Reject Amendment 238
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. While the reference to Article 87 MDR is welcomed, the
proposed wording introduces an unnecessary distinction between a "well-known safety history" and
the absence of safety issues in the past.
A well-known safety history already implies that the technology has demonstrated an acceptable
safety profile over time. The additional requirement therefore appears redundant and risks creating
uncertainty as to whether both conditions are intended to cover different concepts. Clear, non-
overlapping criteria are preferable to ensure a consistent application of the well-established
technology provisions.
It would therefore be preferable to retain the criterion of a well-known safety history and delete the
additional requirement that the technology must not have been associated with safety issues in the
past.
Amendment 239 Article 2(72)
Proposed by András Tivadar Kulja Position of Pharma Deutschland
(b) it has a well-known safety history and has not
been associated with safety issues in the past,
as defined by Article 87;
Reject Amendment 239
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. While the reference to Article 87 MDR is welcomed, the
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proposed wording introduces an unnecessary distinction between a "well-known safety history" and
the absence of safety issues in the past.
A well-known safety history already implies that the technology has demonstrated an acceptable
safety profile over time. The additional requirement therefore appears redundant and risks creating
uncertainty as to whether both conditions are intended to cover different concepts. Clear, non-
overlapping criteria are preferable to ensure a consistent application of the well-established
technology provisions.
It would therefore be preferable to retain the criterion of a well-known safety history and delete the
additional requirement that the technology must not have been associated with safety issues in the
past.
Amendment 240 Article 2(72)
Proposed by Laurent Castillo, Marie-Luce
Brasier-Clain, Valérie Deloge
Position of Pharma Deutschland
(b) it has not been associated with safety issues in
the past within the meaning of Article 87 of
this Regulation;
Accept Amendment 240
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. The reference to Article 87 MDR is welcomed. The
substance of this amendment is identical to that of Amendment 241, although the wording differs.
Therefore, one of the two amendments should be accepted.
Amendment 241 Article 2(72)
Proposed by Aurelijus Veryga Position of Pharma Deutschland
(b) it has not been associated with safety issues in
the past as defined by Article 87;
Accept Amendment 240
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. The reference to Article 87 MDR is welcomed. The
substance of this amendment is identical to that of Amendment 240, although the wording differs.
Therefore, one of the two amendments should be accepted.
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Amendment 242 Article 2(72)
Proposed by Tiemo Wölken Position of Pharma Deutschland
(b) it has not been associated with any safety
issues within the past 20 years;
Reject Amendment 242
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. The clarification of the term "in the past" is welcomed.
However, a period of 10 years would be more appropriate than 20 years. A 20-year timeframe appears
disproportionate and could unnecessarily exclude technologies that have demonstrated long-term
safety and performance but have not been in use for such an extended period.
Amendment 243 Article 2(72)
Proposed by Tiemo Wölken Position of Pharma Deutschland
(ba) it is supported by extensive post market
surveillance and vigilance data
demonstrating a well-established safety
and clinical performance profile;
Reject Amendment 243
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR.
The proposed additional criterion is unnecessary, as the elements of safety and clinical
performance are already covered by the criteria proposed by the European Commission. In
particular, the requirement that a technology has not been associated with safety issues in the past
(letter b) and of a long history (letter d) already rely on post-market surveillance and vigilance
information, while the criterion relating to clinical performance (letter c) addresses the technology's
established clinical characteristics.
The introduction of a separate requirement for "extensive post-market surveillance and vigilance data
demonstrating a well-established safety and clinical performance profile" would therefore be largely
duplicative and would not result in a higher level of patient safety. Instead, it could create uncertainty
regarding the relationship between the different criteria and lead to inconsistent interpretation.
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Amendment 244 Article 2(72)
Proposed by Tiemo Wölken Position of Pharma Deutschland
(c) it has well-known safety and clinical
performance characteristics and comprises
standard of care devices with little evolution in
indications and the state of the art;
Reject Amendment 244
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR.
The proposed additional criterion is unnecessary, as the aspect of safety is already covered by the
criteria proposed by the European Commission. In particular, the requirement that a technology has
not been associated with safety issues in the past (point b) and the requirement of a long history of use
(point d) already imply an established safety profile. Consequently, the proposed criterion would be
largely duplicative and would not contribute to greater legal clarity.
Amendment 245 Article 2(72)
Proposed by Tiemo Wölken Position of Pharma Deutschland
(d) it has been continuously marketed on the
Union market for the duration of minimum 20
years;
Reject Amendment 245
Justification
To provide legal certainty for manufacturers, it is essential to establish clear criteria for well-
established technologies directly in the MDR. The clarification of the term "a long history on the Union
market" is welcomed.
However, a period of 10 years would be more appropriate than 20 years. A 20-year timeframe appears
disproportionate and could unnecessarily exclude technologies that have demonstrated long-term
safety and performance but have not been in use for such an extended period.
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Amendment 246 Article 2(72)
Proposed by Laurent Castillo, Marie-Luce
Brasier-Clain, Valérie Deloge
Position of Pharma Deutschland
da) qualification as a well-established
technology device must be based on
objective and harmonised criteria that are
applied uniformly throughout the Union.
Reject Amendment 246
Justification
The objective of ensuring objective and harmonised criteria that are applied uniformly throughout the
Union is welcomed.
However, this requirement should not form part of the definition of a well-established technology.
It does not constitute a substantive criterion for determining whether a technology qualifies as well-
established, but rather describes how the qualification criteria should be applied.
Therefore, this element would be more appropriately addressed in a recital or a separate provision
rather than included in the definition itself.
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▪ Status of Products
Article 4
The current version of Article 4 includes a legally binding procedure for the determination of the
regulatory status of a product. Such a procedure has been missing under the former Directive
93/42/EEC on medical devices and therefore it is an appreciated improvement. As no procedure
according to the current Article 4 MDR has been conducted yet, it remains unclear why the
European Commission suggests an amendment to this provision. The Draft Report of the
Committee on Public Health of the European Parliament proposed some amendments to
Article 4 (Amendments 17, 18, 19, 20 and 21). Several amendments concerning Article 4 have
been submitted (Amendments 267 ff).
Amendments 267 and 268 Article 4(1)
Proposed by Ruggero Razza, Michele Picaro
and by Letizia Moratti, Dolors Montserrat,
Elena Nevado del Campo
Position of Pharma Deutschland
1. The competent authorities of the Member
States shall coordinate their activities when
determining whether a specific product, or
category, or group of products, that is already
available on the market falls within the
definition of ‘medical device’ set out in Article
2, point (1), or the definition of ‘accessory for a
medical device’ set out in Article 2, point (2), or
whether a product falls within the scope of
Annex XVI or is an accessory for a product
listed in that Annex.
Accept Amendments 267 and 268
Justification
In accordance with the case law of the European Court of Justice, the regulatory status of a product
shall be determined through a case-by-case assessment. Consequently, the deletion of references
to product categories or groups is welcomed, as they may undermine an individual assessment of each
product.
For products that are CE-marked in accordance with Article 20, existing mechanisms already address
situations where a device presents an unacceptable risk to patients or otherwise fails to comply with
the requirements of the Regulation (Article 95 and 97). The principle of the free movement of goods, as
laid down in Article 24 MDR and Articles 34 and 36 TFEU and further explained in the Blue Guide, should
be safeguarded to the greatest extent possible in order to ensure legal certainty for manufacturers.
A proportionate approach would require a competent authority of a Member State that has
substantiated evidence that a product which is CE marked in accordance with Article 20 does not fall
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within the scope of this Regulation, and which has conducted an evaluation pursuant to Article 94, to
consult the competent authority of the Member State in which the manufacturer has its registered
place of business, and inform the manufacturer and the notified body concerned. In the event of
disagreement between the consulting competent authority and the competent authority of the
Member State in which the manufacturer has its registered place of business, an expert panel should
be consulted in accordance with Article 4a. There is no need to involve the competent authorities of all
other Member States in such a procedure. Instead, those authorities should be informed of any expert
panel opinions relating to the determination of the regulatory status of a CE-marked product in
accordance with Article 4a.
Amendment 269 Article 4(1)
Proposed by Sirpa Pietikäinen Position of Pharma Deutschland
2a. National competent authorities of the
relevant sectorial legislation shall take into
account the opinion of the relevant Union
level advisory or regulatory bodies
established in the Union legislation.
Reject Amendment 269
Justification
The proposed provision lacks sufficient clarity. Several key terms, including "relevant sectorial
legislation", "relevant Union level advisory or regulatory bodies" and the extent to which national
competent authorities are required to "take into account" their opinions, would require further
clarification.
The addition of this provision is therefore likely to create legal uncertainty rather than improve the
regulatory framework. Furthermore, it is unclear how the proposed wording would contribute to a
higher level of patient safety or a more efficient determination of the regulatory status of products.
Amendment 270 Article 4(3)
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
3. Where a competent authority of a Member
State, after having performed an evaluation in
accordance with Article 94, considers and
having regard to the provisions of paragraph
5a has substantiated evidence that a product
that is CE marked in accordance with Article
20, does not fall within the scope of this
Reject Amendment 270
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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.
Justification
A proportionate approach would require a competent authority of a Member State that has
substantiated evidence that a product which is CE marked in accordance with Article 20 does not fall
within the scope of this Regulation, and which has conducted an evaluation pursuant to Article 94, to
consult the competent authority of the Member State in which the manufacturer has its registered
place of business, and inform the manufacturer and the notified body concerned. In the event of
disagreement between the consulting competent authority and the competent authority of the
Member State in which the manufacturer has its registered place of business, an expert panel should
be consulted in accordance with Article 4a. There is no need to involve the competent authorities of
all other Member States in such a procedure. Instead, those authorities should be informed of any
expert panel opinions relating to the determination of the regulatory status of a CE-marked product in
accordance with Article 4a.
The substance of this amendment is identical to that of Amendment 271, although the wording differs.
Both amendments should be rejected.
Amendment 271 Article 4(3)
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
3. Where a competent authority of a Member
State, after having performed an evaluation in
accordance with Article 94, considers and
taking into account the provisions of
paragraph 5a, has well-founded evidence
that a product that is CE marked in accordance
with Article 20, 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.
Reject Amendment 271
Justification
A proportionate approach would require a competent authority of a Member State that has
substantiated evidence that a product which is CE marked in accordance with Article 20 does not fall
within the scope of this Regulation, and which has conducted an evaluation pursuant to Article 94, to
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consult the competent authority of the Member State in which the manufacturer has its registered
place of business, and inform the manufacturer and the notified body concerned. In the event of
disagreement between the consulting competent authority and the competent authority of the
Member State in which the manufacturer has its registered place of business, an expert panel should
be consulted in accordance with Article 4a. There is no need to involve the competent authorities of
all other Member States in such a procedure. Instead, those authorities should be informed of any
expert panel opinions relating to the determination of the regulatory status of a CE-marked product in
accordance with Article 4a.
The substance of this amendment is identical to that of Amendment 270, although the wording differs.
Both amendments should be rejected.
Amendment 272 Article 4(4)
Proposed by Laurent Castillo, Margarita de la
Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Position of Pharma Deutschland
4. Where a competent authority of a Member State
raises The competent authorities of other
Member States may submit an opinion
within a maximum period of 90 days from
the date of the referral. Where at least five
competent authorities of Member States
raise a substantiated disagreement regarding
the envisaged measure referred to in
paragraph 3, the consulting authority shall
refer the matter to an expert panel as referred
to in Article 106 and shall be referred to and
the competent authority of the Member
State shall give utmost consideration to the
opinion of that expert panel.
Reject Amendment 272
Justification
A proportionate approach would require a competent authority of a Member State that has
substantiated evidence that a product which is CE marked in accordance with Article 20 does not fall
within the scope of this Regulation, and which has conducted an evaluation pursuant to Article 94, to
consult the competent authority of the Member State in which the manufacturer has its registered
place of business, and inform the manufacturer and the notified body concerned. In the event of
disagreement between the consulting competent authority and the competent authority of the
Member State in which the manufacturer has its registered place of business, an expert panel should
be consulted in accordance with Article 4a. There is no need to involve the competent authorities of
all other Member States in such a procedure. Instead, those authorities should be informed of any
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expert panel opinions relating to the determination of the regulatory status of a CE-marked product in
accordance with Article 4a.
The requirement that at least five competent authorities raise a substantiated disagreement before an
expert panel can be consulted adds procedural complexity without providing a clear regulatory
benefit. A more targeted procedure would be more efficient while maintaining legal certainty and
ensuring consistent regulatory qualification across the Union.
Amendment 273 Article 4(5a)
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
5a. For CE-marked products that have
undergone an Article 52 conformity
assessment with a notified body, the
procedure referred to in this Article shall
only apply if the competent authority in
question has comprehensive evidence that
the regulatory status of the product as a
medical device poses an unacceptable risk
pursuant to Article 94(a). The product’s
regulatory status shall not, in and of itself,
constitute such evidence.
Reject Amendment 273
Justification
Before the regulatory status of a product that is already lawfully placed on the market can be
challenged, clearly defined criteria should be fulfilled. It is essential to provide legal certainty for
manufacturers and to reaffirm the central role of CE certificates as evidence of conformity with the
requirements of the MDR. A valid CE certificate should give rise to a presumption that the product
complies with the applicable requirements of the MDR. This approach safeguards legal certainty and
supports the free movement of goods within the Union.
However, the proposed limitation of the procedure to cases in which the competent authority has
comprehensive evidence that the regulatory status of the product as a medical device poses an
unacceptable risk pursuant to Article 94(a) is not appropriate. Unacceptable risks are already
addressed under Article 95. In terms of market surveillance national authorities are empowered to
verify the regulatory status of products distributed in their territory. Hence, linking the applicability of
the coordination procedure to the existence of an unacceptable risk would unduly restrict the
possibility for competent authorities to take action in exceptional and duly justified cases. The
procedure should therefore not be conditional upon evidence that the product’s regulatory status
poses an unacceptable risk pursuant to Article 94(a).
The clarification that a product’s regulatory status should not, in and of itself, constitute evidence
of an unacceptable risk is appropriate in principle. The regulatory status of a product and the risks
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posed by that product are distinct issues and should not be conflated. This clarification should
therefore be added in Article 94. Nevertheless, this clarification does not remedy the fundamental
issue created by the first sentence, namely that the coordination procedure would be linked to the
existence of an unacceptable risk pursuant to Article 94(a). The second sentence is therefore not
sufficient to make the amendment acceptable.
The substance of this amendment is identical to that of Amendment 274, although the wording differs.
Both amendments should be rejected.
Amendment 274 Article 4(5a)
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
5a. For products that are CE marked and for
which the conformity assessment referred
to in Article 52 involved a notified body, the
procedure referred to in in this article shall
apply only where the competent authority
concerned has substantiated evidence that
the qualification of the product as a medical
device represents an unacceptable risk as
referred to in Article 94, point (a). The
regulatory qualification of the product shall
not, in itself, constitute such evidence.
Reject Amendment 274
Justification
Before the regulatory status of a product that is already lawfully placed on the market can be
challenged, clearly defined criteria should be fulfilled. It is essential to provide legal certainty for
manufacturers and to reaffirm the central role of CE certificates as evidence of conformity with the
requirements of the MDR. A valid CE certificate should give rise to a presumption that the product
complies with the applicable requirements of the MDR. This approach safeguards legal certainty and
supports the free movement of goods within the Union.
However, the proposed limitation of the procedure to cases in which the competent authority has
comprehensive evidence that the regulatory status of the product as a medical device poses an
unacceptable risk pursuant to Article 94(a) is not appropriate. Unacceptable risks are already
addressed under Article 95. In terms of market surveillance national authorities are empowered to
verify the regulatory status of products distributed in their territory. Hence, linking the applicability of
the coordination procedure to the existence of an unacceptable risk would unduly restrict the
possibility for competent authorities to take action in exceptional and duly justified cases. The
procedure should therefore not be conditional upon evidence that the product’s regulatory status
poses an unacceptable risk pursuant to Article 94(a).
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The clarification that a product’s regulatory status should not, in and of itself, constitute evidence
of an unacceptable risk is appropriate in principle. The regulatory status of a product and the risks
posed by that product are distinct issues and should not be conflated. This clarification should
therefore be added in Article 94. Nevertheless, this clarification does not remedy the fundamental
issue created by the first sentence, namely that the coordination procedure would be linked to the
existence of an unacceptable risk pursuant to Article 94(a). The second sentence is therefore not
sufficient to make the amendment acceptable.
The substance of this amendment is identical to that of Amendment 273, although the wording differs.
Both amendments should be rejected.
Amendment 275 Article 4(5b)
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
5b. Having regard to the expert panel opinion
referred to in Article 4(4), a Member State
may submit a substantiated request to the
Commission to determine whether a
specific product falls within the definitions
of ‘medical device’ or ‘accessory for a
medical device’, or whether a product falls
within the scope of Annex XVI or is an
accessory for a product listed in that Annex.
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 114(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.
Refuse Amendment 275
Justification
The objective of this Amendment is unclear. The Commission proposal already provides a mechanism
enabling the Commission to adopt an implementing act on the regulatory status of a product following
the procedure laid down in Article 4a(3). The additional provision therefore appears unnecessary and
risks creating overlap with the existing procedure.
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Furthermore, the involvement of the Commission should only be triggered by a substantiated
request from a Member State. This ensures that the procedure is based on a concrete regulatory
concern identified and assessed by a competent authority.
The substance of this amendment is identical to that of Amendment 276, although the wording differs.
Both amendments should be rejected.
Amendment 276 Article 4(5b)
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
5b. Having regard to the expert panel opinion
referred in Article 4(4), a Member State may
submit a substantiated request to the
Commission to determine whether a
specific product falls within the definitions
of ‘medical device’ or ‘accessory for a
medical device’, or whether a product falls
within the scope of Annex XVI or is an
accessory for a product listed in that Annex.
The Commission may 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 114(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.
Reject Amendment 276
Justification
The objective of this Amendment is unclear. The Commission proposal already provides a mechanism
enabling the Commission to adopt an implementing act on the regulatory status of a product following
the procedure laid down in Article 4a(3). The additional provision therefore appears unnecessary and
risks creating overlap with the existing procedure.
Furthermore, the involvement of the Commission should only be triggered by a substantiated
request from a Member State. This ensures that the procedure is based on a concrete regulatory
concern identified and assessed by a competent authority.
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The clarification provided by Letizia Moratti, Dolors Montserrat and Elena Nevado del Campo that
responsibility for verifying the correct regulatory qualification of a product lies with the competent
authority of the Member State where the manufacturer has its registered place of business,
including in cases of disagreement between the manufacturer and the notified body, is welcomed. This
principle should be explicitly reflected in the legal provisions of Article 4 in order to ensure legal
certainty and a harmonised approach throughout the Union.
The substance of this amendment is identical to that of Amendment 275, although the wording differs.
Both amendments should be rejected.
Amendment 277 Article 4(5c)
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
5c. When assessing whether a product may fall
within a regulatory category other than that
of medical devices, the competent
authorities and the expert panel referred to
in paragraph 4 of this Article shall give
utmost consideration to whether the
product concerned is capable to comply
with the sector-specific legislation
applicable to the category to which it is
proposed to be assigned. Where that
category is that of medicinal products,
particular attention shall be taken to
assess, on the basis of the mechanism of
action described by the manufacturer,
whether the product could legally and
practically obtain the relevant marketing
authorisation. This assessment shall be
carried out in order to ensure that any
reclassification does not result in the loss of
treatment options for patients.
Accept Amendment 277
(Note: This Amendment could be placed under
Article 4a(2))
Justification
When assessing the regulatory status of a product, it is essential to consider whether the product can
realistically comply with the requirements of that framework.
In particular, where a product is proposed to be classified as a medicinal product, it should be verified
whether the product could legally and practically obtain a marketing authorization under the applicable
pharmaceutical legislation.
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The proposed wording reduces the risk that products which are already available to patients are
removed from the market solely as a consequence of a change in regulatory status. The explicit
requirement to consider the potential impact on the availability of treatment options for patients is
particularly welcomed.
Note: As the amendment concerns the assessment by the expert panel, it would be more appropriately
placed in Article 4a(2).
Amendment 278 Article 4(5c)
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
5c. Where such a product is deemed to have a
different regulatory status following the
coordination activities or subsequent
regulatory assessment, any clinical or non-
clinical data or data pertaining to post-
market surveillance and vigilance and any
other evidence of real-world use that was
generated or collected during the period in
which the product was lawfully placed on
the market as a medical device shall remain
admissible and may be taken into account
for the purposes of a subsequent
application or regulatory assessment,
where relevant and scientifically valid.
Accept Amendment 278
Justification
Where a product is requalified and assigned a different regulatory status, it is essential that clinical
data, non-clinical data, post-market surveillance and vigilance data, as well as evidence derived from
real-world use, remain admissible where scientifically valid and relevant.
Such information reflects extensive experience gained while the product was lawfully placed on the
market and may provide valuable evidence regarding its safety, performance and benefit-risk profile.
Disregarding these data solely because of a change in regulatory qualification would be
disproportionate and could lead to unnecessary duplication of studies and assessments.
The proposed wording promotes regulatory efficiency, reduces unnecessary administrative
burdens and supports legal certainty for manufacturers. It also helps ensure that requalification
decisions do not result in the unnecessary withdrawal of established products from the market or the
loss of treatment options for patients.
If both Amendments 277 and 278 are accepted, Amendment 278 should be renumbered as point (d),
as both amendments currently introduce a new paragraph 5c.
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Amendment 279 Article 4(6)
Proposed by Laurent Castillo, Margarita de la
Pisa Carrión, Ondřej Knotek, Marie-Luce
Brasier Clain, Valérie Deloge, Viktória Ferenc
Position of Pharma Deutschland
6. The Commission may, by means of
implementing acts, lay down the procedure,
including timelines, for the application of
paragraphs 1 to 4 of this Article and of Article
4a. Those implementing acts shall be adopted
in accordance with the examination procedure
referred to in Article 114(3). The Commission
shall consult stakeholders and Member
States. ;
Accept Amendment 279
(Note: The procedure under Article 4(6) is
unnecessary and therefore this provision should
be deleted. Nevertheless, if Article 4(6) is
maintained in the final legislative text, this
amendment is welcomed as it represents an
improvement compared to the Commission
proposed wording)
Justification
The explicit requirement for the Commission to consult stakeholders and Member States before
adopting implementing acts increases transparency and contributes to a practical and proportionate
implementation of Articles 4 and 4a.
Such consultation will help ensure legal certainty, facilitate consistent application across the Union
and allow relevant expertise and regulatory experience to be taken into account when establishing
procedural rules and timelines.
However, it is questionable whether an empowerment for the Commission to lay down additional
procedural rules and timelines is necessary. The proposed legal provisions already contain detailed
procedural requirements and deadlines. Any further implementing measures should therefore be
limited to aspects that are not already sufficiently addressed in the Regulation itself.
Amendment 280 Article 4(6)
Proposed by Laurent Castillo, Margarita de la
Pisa Carrión, Ondřej Knotek, Marie-Luce
Brasier Clain, Valérie Deloge, Viktória Ferenc
Position of Pharma Deutschland
6. The Commission may shall, by means of
implementing acts, lay down the procedure,
including timelines and involvement of
concerned stakeholders, for the application
of paragraphs 1 to 4 of this Article and of Article
Partially accept Amendment 280
(Note: The procedure under Article 4(6) is
unnecessary and therefore this provision should
be deleted. Nevertheless, if Article 4(6) is
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4a. Those implementing acts shall be adopted
in accordance with the examination procedure
referred to in Article 114(3).;
maintained in the final legislative text, this
amendment is partially welcomed as it represents
an improvement compared to the Commission
proposed wording)
Justification
The explicit involvement of concerned stakeholders is particularly important. Stakeholder
participation contributes to transparency, practicality and regulatory consistency and helps ensure
that the implementing acts adequately reflect regulatory experience and the realities of product
qualification procedures.
However, it is questionable whether an empowerment for the Commission to lay down additional
procedural rules and timelines is necessary. The proposed legal provisions already contain detailed
procedural requirements and deadlines. Any further implementing measures should therefore be
limited to aspects that are not already sufficiently addressed in the Regulation itself.
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▪ Opinion on and determination of the regulatory status of a product
Article 4a
The European Commission proposes a new Article 4a concerning opinions issued by expert
panels on the determination of the regulatory status of products. Under the Commission
proposal, competent authorities, manufacturers, developers and notified bodies would be
entitled to submit a substantiated request for an opinion. The involvement of expert panels is
welcome. While the proposed procedure is more transparent and structured than the current
framework, it still does not ensure the systematic involvement of industry expertise in the
assessment process. Such expertise could provide valuable technical and scientific input,
particularly in cases involving innovative technologies or complex borderline products. The
possibility of consulting expert panels cannot fully compensate for the continued absence of
industry experts from the decision-making process.
The amendments proposed in the Draft Report of the Committee on Public Health of the
European Parliament do not allow manufacturers, developers or notified bodies to submit a
substantiated request to an expert panel for a scientific and technical opinion on the
determination of the regulatory status of a product (Amendments 22, 23, 24, 25 and 26). Such
a possibility is, however, provided for questions relating to the classification of devices under
proposed Articles 51a and 51b. Several amendments concerning Article 4a have been
submitted (Amendments 281 ff.).
Amendment 281 Article 4a(5)
Proposed by Tiemo Wölken Position of Pharma Deutschland
5. Any opinion of an expert panel relating to the
determination of the regulatory status of a
product shall be made publicly available,
without disclosing confidential information
in accordance with Article 109.
Reject Amendment 281
Justification
Transparency regarding regulatory status determinations is generally welcomed. However, the
publication of expert panel opinions should be limited to cases concerning products that are
already CE-marked and lawfully placed on the market.
For innovative products that are still under development or undergoing conformity assessment, the
publication of expert panel opinions may reveal commercially sensitive information and could
negatively affect innovation and investment. The protection of business information should therefore
be carefully balanced against transparency objectives.
Consequently, expert panel opinions should only be made publicly available where they concern CE-
marked products and where publication does not adversely affect innovation and competition.
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Amendment 282 Article 4a(1)
Proposed by Tiemo Wölken Position of Pharma Deutschland
1. A competent authority, a notified body, the a
manufacturer or a developer of a the product
concerned, provided that it is responsible
for the development or placing on the
market of that product, or the Commission
may submit a substantiated request for an
opinion from an expert panel referred to in
Article 106 on the question whether a specific
product, or category or group of products, falls
within the definitions of ‘medical device’ or
‘accessory for a medical device’, or whether a
product falls within the scope of Annex XVI or
is an accessory for a product listed in that
Annex. Where, in such a request, the requester
considers that the product in question is a
device, the request shall also specify the
proposed classification of the device in
accordance with Article 51 and Annex VIII.
Accept Amendment 282
Justification
It is essential that manufacturers and developers are entitled to request an opinion from an expert
panel on questions relating to the regulatory status of a product. Such access promotes legal certainty,
facilitates the development of innovative products and helps to ensure a more harmonised
interpretation of the MDR throughout the Union.
The expansion of this right to the manufacturer or developer of the product concerned is welcomed, as
it ensures a direct and legitimate interest in the requested opinion while preventing the misuse of the
procedure by unrelated third parties.
The proposed amendment therefore strikes an appropriate balance between access to expert advice
and the efficient functioning of the qualification procedure.
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Amendments 283 and 284 Article 4a(1)
Proposed by Ruggero Razza, Michele Picaro
and by Letizia Moratti, Dolors Montserrat,
Elena Nevado del Campo
Position of Pharma Deutschland
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 on the question
whether a specific product, or category or
group of products, falls within the definitions of
‘medical device’ or ‘accessory for a medical
device’, or whether a product falls within the
scope of Annex XVI or is an accessory for a
product listed in that Annex. Where, in such a
request, the requester considers that the
product in question is a device, the request
shall also specify the proposed classification
of the device in accordance with Article 51 and
Annex VIII.
Partially accept Amendments 283 and 284
Justification
In accordance with the case law of the European Court of Justice, the regulatory status of a product
shall be determined through a case-by-case assessment. Consequently, the deletion of references
to product categories or groups is welcomed, as they may undermine an individual assessment of
each product.
It is essential that manufacturers and developers have the possibility to request an expert panel
opinion on the regulatory qualification of a product, particularly where innovative products are
concerned and before significant investments are made in the conformity assessment process.
Early access to an expert panel opinion can help prevent divergent interpretations of the MDR, reduce
regulatory uncertainty and facilitate the development of innovative products. This is particularly
important for products that have not yet been CE-marked and for which the applicable regulatory
framework may not be sufficiently clear.
Limiting access to this procedure to competent authorities would significantly reduce its practical
value and would deprive manufacturers and developers of an important mechanism for obtaining
regulatory certainty at an early stage of product development.
Furthermore, restricting the procedure to products that are already CE-marked would fail to address
the situations in which regulatory qualification guidance is most needed. The ability to seek
clarification before placing a product on the market contributes to innovation, reduces unnecessary
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regulatory burdens and ultimately benefits patients by facilitating timely access to innovative
technologies.
Amendment 285 Article 4a(1)
Proposed by Sirpa Pietikäinen Position of Pharma Deutschland
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 to confirm the mode
of action, where necessary and on the
question whether a specific product, or
category or group of products, falls within the
definitions of ‘medical device’ or ‘accessory for
a medical device’, or whether a product falls
within the scope of Annex XVI or is an
accessory for a product listed in that Annex.
Where, in such a request, the requester
considers that the product in question is a
device, the request shall also specify the
proposed classification of the device in
accordance with Article 51 and Annex VIII.
Reject Amendment 285
Justification
The concept of confirming the mode of action "where necessary" lacks sufficient precision and may
create uncertainty regarding the scope of the expert panel's mandate.
It is unclear who determines when such confirmation is necessary and according to which criteria. This
could result in inconsistent qualification procedures and divergent interpretations among competent
authorities and expert panels.
The proposed wording does not appear to provide additional legal certainty for manufacturers and may
instead complicate the determination of the regulatory status of borderline products.
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Amendment 286 Article 4a(2)
Proposed by Laurent Castillo, Margarita de la
Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Position of Pharma Deutschland
2. The expert panel shall provide its opinion
without undue delay and within a period of 90
days from the date of receipt of a complete
application, unless there are properly
justified scientific or technical reasons that
necessitate an extension. The requester shall
give utmost consideration to the opinion of the
expert panel. Where the opinion relates to an
application submitted by a third party, the
manufacturer or developer of the product in
question shall have the opportunity to
submit comments before the opinion
becomes definitive.
Partially accept Amendment 286
Justification
The introduction of a clear timeline for the delivery of expert panel opinions is welcomed and
contributes to greater predictability and legal certainty for all parties involved.
However, the possibility to extend the 90-day deadline on the basis of "properly justified scientific or
technical reasons" remains too broad and may result in inconsistent application. More precise criteria
for any extension would be preferable in order to avoid unnecessary delays and ensure procedural
transparency.
Furthermore, the requirement to provide the manufacturer or developer of the product concerned with
an opportunity to submit comments is strongly supported. However, this right should not be limited to
situations where the request has been submitted by a third party.
Given the potentially significant consequences of an expert panel opinion for the regulatory status of a
product, the manufacturer or developer concerned should always be consulted before the
opinion becomes definitive. This would ensure that all relevant technical, scientific and regulatory
information can be taken into account and would strengthen the fairness, transparency and quality of
the procedure.
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Amendment 287 Article 4a(4)
Proposed by Laurent Castillo, Margarita de la
Pisa Carrión, Marie-Luce Brasier-Clain, Valérie
Deloge, Viktória Ferenc
Position of Pharma Deutschland
4. Where the regulatory status of a product or
category of products has already been
determined under this Regulation or
established prior to its date of entry into
force, that status shall remain in effect
unless there is new scientific or technical
evidence showing that the criteria for that
decision are no longer fulfilled.
Accept Amendment 287
Justification
Regulatory qualification decisions may have significant consequences for manufacturers, developers,
notified bodies and patients. Once a product's regulatory status has been established, it should not be
reconsidered without a justified reason.
The proposed wording strengthens legal certainty and regulatory predictability by ensuring that
previously established qualification decisions remain valid unless new scientific or technical evidence
demonstrates that the underlying criteria are no longer fulfilled.
The amendment is also important for innovation and investment planning. Manufacturers and
developers must be able to rely on established regulatory decisions when developing, certifying and
marketing products. Reopening qualification decisions without new evidence would create uncertainty
and could discourage innovation.
Furthermore, maintaining previously established regulatory status unless justified by new evidence
contributes to the harmonised application of the MDR throughout the Union and helps safeguard the
free movement of goods as established in Article 24 MDR.
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▪ Implant card and information to be supplied to the patient with an implanted device
Article 18
The European Commission has amended Article 18(3) by excluding implants that are well-
established technology devices from the obligations to provide an implant card and to submit
information to the patient. The Draft Report of the Committee on Public Health of the
European Parliament proposes the deletion of this exception (Amendment 42). Several
amendments concerning Article 18(3) have been submitted (Amendments 398 ff.).
Amendments 398, 399, 400 and 401 Article 18(3)
Proposed by Laurence Trochu, by Valentina
Palmisano, by Ignazio Roberto Marino on behalf
of the Verts/ALE Group and by Kateřina
Konečná
Position of Pharma Deutschland
Deletion of proposed Article 18(3) Reject Amendments 398, 399, 400 and 401
Justification
The current wording of Article 18(3) already exempts certain products, such as sutures, staples, dental
fillings, dental braces, dental crowns, screws, wedges, plates, wires, pins, clips and connectors, from
the obligations set out in Article 18.
The Commission's proposal appropriately extends this exemption to implants qualifying as well-
established technologies (WETs). Such products are characterised by extensive experience of use,
a well-established safety profile and proven clinical performance. Requiring the full set of
information obligations under Article 18 for these products would therefore not provide a
commensurate benefit for patients.
Deleting the proposed extension would mean that only the products currently listed in Article 18(3)
would remain exempt. As a result, implants qualifying as well-established technologies would
continue to be subject to the information requirements of Article 18 unless they are already covered by
the existing exhaustive list.
Maintaining different regulatory treatment for comparable well-established implants would be
difficult to justify and would create unnecessary regulatory burdens without improving patient safety.
The Commission's proposal therefore represents a more proportionate and coherent approach and
should be retained.
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Amendment 402 Article 18(3)
Proposed by Tiemo Wölken Position of Pharma Deutschland
3. The following implants that are well-
established technology devices shall be
exempted from the obligations laid down in
this Article: sutures, staples, dental fillings,
dental braces, tooth crowns, screws,
wedges, plates, wires, pins, clips and
connectors. The Commission is empowered
to adopt delegated acts in accordance with
Article 115 to amend this list by adding other
types of implants to it or by removing
implants therefrom. In exercising that
power, the Commission shall, in particular,
consider adding implants that remain in the
human body only temporarily or are fully
resorbed by the human body. Class III
implantable devices shall not be exempted
pursuant to this paragraph.
Reject Amendment 402
Justification
The proposed amendment would effectively reinstate and further narrow the scope of Article 18(3)
MDR, under which only a limited and exhaustive list of implants benefits from the exemption from the
information obligations laid down in Article 18.
Well-established technology devices are characterized by extensive clinical experience, a well-
established safety profile and proven clinical performance.
Restricting the exemption to the currently listed implants would mean that other implants qualifying as
well-established technologies would continue to be subject to the information requirements of Article
18 solely because they are not included in the existing exhaustive list. This would result in different
regulatory treatment of comparable products without a corresponding benefit for patients.
The Commission's proposal provides a more proportionate and future-proof approach by linking the
exemption to objective qualification criteria rather than to a fixed list of products. It also ensures that
new or evolving well-established technologies can benefit from the exemption without requiring
repeated legislative amendments.
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Amendment 403 Article 18(3)
Proposed by Laurent Castillo, Marie-Luce
Brasier-Clain, Valérie Deloge
Position of Pharma Deutschland
3. Implants that are constitute well established
technological devices shall be exempted from
remain subject to the obligations laid down
information requirements provided for in
this Article. That information may be
provided in electronic or digital format in
accordance with paragraph 1.
Reject Amendment 403
Justification
The proposed amendment would be stricter than the current wording of Article 18(3) MDR.
Well-established technology devices are characterised by extensive clinical experience, a well-
established safety profile and proven clinical performance. For such products, maintaining the full
information requirements of Article 18 despite their established characteristics would not provide a
commensurate benefit for patients.
The Commission's proposal appropriately recognises the specific features of well-established
technologies by exempting qualifying implants from the obligations laid down in Article 18. By contrast,
the proposed amendment would subject all well-established technology implants to those obligations,
irrespective of their established safety and performance record.
This would create unnecessary regulatory burdens and result in a less proportionate regulatory
framework without a corresponding improvement in patient safety. The Commission's proposal
therefore represents the more balanced and risk-based approach and should be retained.
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▪ Clinical evaluation
Article 61(5)
The European Commission has proposed measures to make the use of equivalence more feasible
in practice while maintaining a high level of patient safety. Pharma Deutschland welcomes this
approach. In many cases, relevant clinical data are already available for devices that are
equivalent to the device undergoing conformity assessment. Requiring manufacturers to generate
additional clinical data in such situations may result in unnecessary duplication of efforts and
increased regulatory costs without providing a corresponding benefit for patient safety.
The Draft Report of the Committee on Public Health of the European Parliament does not
propose any amendments to this provision. Several amendments concerning Article 61(5)
have been submitted.
Amendments 560, 561, 562 and 563 Article 61(5)
Proposed by Ignazio Roberto on behalf of the
Verts/ALE Group, by Kateřina Konečná, by
Valentina Palmisano and by Tiemo Wölken
Position of Pharma Deutschland
Deletion of proposed Article 61(5) Reject Amendments 560, 561, 562 and 563
Justification
The current requirement to conclude a contract with the manufacturer of the equivalent device and to
obtain unrestricted access to its technical documentation is, in practice, rarely achievable and
significantly limits the use of the equivalence concept. The removal of these requirements, as
proposed by the Commission, would substantially improve the practical applicability of equivalence
and avoid unnecessary clinical investigations without compromising the high level of protection
established by the MDR.
Where robust clinical data are available for a demonstrably equivalent device and compliance of the
original clinical evaluation with the MDR can be demonstrated, generating additional clinical data does
not provide any additional benefit for patient safety.
The deletion of the Commission proposal would maintain requirements that have proven to be largely
unworkable in practice and would continue to restrict the use of equivalence beyond what is necessary
to ensure patient safety. A more flexible and proportionate approach to equivalence is therefore
warranted.
The Commission proposal strikes a more appropriate balance between ensuring a high level of patient
safety, reducing unnecessary clinical investigations and facilitating innovation. It should therefore be
retained.
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Amendment 564 Article 61(5)
Proposed by Laurence Trochu Position of Pharma Deutschland
5. With the exception of class III, IIb and IIa
devices where such devices integrate new
components, a manufacturer of a device
demonstrated to be equivalent, in terms of
performance and safety, to an already
marketed device not manufactured by it, may
also rely on paragraph 4 in order not to perform
a clinical investigation provided that the
original clinical evaluation has been
performed in compliance with the
requirements of this Regulation and the
manufacturer requesting equivalence
provides clear evidence thereof to the notified
body.
Reject Amendment 564
Justification
The proposed exception for class III, class IIb and class IIa devices incorporating new components
would significantly restrict the practical applicability of the equivalence concept. In particular, the term
“new components” is not defined and creates considerable legal uncertainty for manufacturers,
notified bodies and competent authorities.
The mere integration of new components should not automatically preclude reliance on equivalence.
Instead, the decisive criterion should be whether the relevant modification has an actual impact on the
safety, performance or benefit-risk profile of the device. Otherwise, there is a risk that unnecessary
clinical investigations will be required even where robust clinical data already exist for a demonstrably
equivalent device.
The proposed restriction would substantially weaken the improvement in the practical usability of
the equivalence concept envisaged by the Commission proposal and could create unnecessary
barriers to innovation.
Amendment 565 Article 61(5)
Proposed by Ondřej Dostál Position of Pharma Deutschland
5. A manufacturer of a device demonstrated to be
equivalent to an already marketed device not
manufactured by it, may also rely on paragraph
4 in order not to perform a clinical investigation
provided that the original clinical evaluation
Accept Amendment 565
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has been performed in compliance with the
requirements of this Regulation and the
manufacturer provides clear evidence thereof
to the notified body;
Justification
This amendment is welcomed as it maintains the key improvements introduced by the
Commission’s proposal and removes the requirement, which is practically impossible to fulfil in many
cases, to obtain access to a competitor's technical documentation. This would significantly improve
the practical applicability of the equivalence concept. The current requirement to conclude a
contract with the manufacturer of an equivalent device and to obtain unrestricted access to its
technical documentation has proven to be largely unworkable in practice and has significantly limited
the use of equivalence under the MDR.
Compared to Amendment 92 of the Draft Report, this amendment is preferable because it does
not exclude implantable class III devices from the possibility of relying on equivalence. Such a blanket
exclusion does not appear proportionate where robust clinical data are available for a demonstrably
equivalent device and equivalence can be scientifically justified.
Where compliance of the original clinical evaluation with the MDR can be demonstrated and sufficient
clinical evidence is available, requiring additional clinical investigations does not necessarily provide
additional benefits for patient safety. The amendment therefore represents a more proportionate and
practical approach to equivalence.
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▪ Periodic safety update report
Article 86(1)
The European Commission proposed an amendment to the second subparagraph of Article 86(1),
requiring manufacturers of class IIb and class III devices to update the PSUR during the first year
after issuance of the certificate and subsequently every two years, or whenever there is a
significant change in the benefit-risk determination or in the acceptability of undesirable side
effects.
In addition, the Commission proposed an amendment to the third subparagraph of Article 86(1),
allowing manufacturers of class IIa devices to update the PSUR whenever necessary. This
amendment is welcomed, as it reduces unnecessary administrative burdens while maintaining
the current level of patient safety. However, the Draft Report proposes reintroducing an
obligation for manufacturers of class IIa devices to update the PSUR at least once during the
first two years following the issuance of the certificate. Pharma Deutschland does not support
this approach. Several amendments concerning Article 86(1) have been submitted
(Amendments 582 ff.).
Amendment 582 Article 86(1) subparagraph 2
Proposed by Valentina Palmisano Position of Pharma Deutschland
(2) Manufacturers of class IIb and class III 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 undesirable side-effects, or
when otherwise necessary, including but
not limited to changes in the frequency or
severity of incidents or side effects,
following the occurrence of a serious
incident or identification of a new safety
signal, following the implementation of a
field safety corrective action, or when new
clinical or performance data becomes
available that may impact the evaluation of
safety or performance. The PSUR shall be
part of the technical documentation as
specified in Annex III.
Reject Amendment 582
Justification
The wording “or when otherwise necessary” is overly broad and does not provide sufficient legal
certainty for manufacturers. Combined with the expressly non-exhaustive list of potential triggers, it
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creates considerable scope for interpretation by manufacturers, notified bodies and competent
authorities.
In particular, not every serious incident, field safety corrective action, or newly available clinical or
performance-related information should automatically trigger an unscheduled update of the PSUR.
Rather, the decisive factor should be whether the relevant information results in a significant change in
the benefit-risk determination or in the assessment of the device’s safety or performance. The trigger
criteria already contained in the proposed wording are sufficient for this purpose.
Amendments 583 Article 86(1) subparagraph 2
Proposed by Ignazio Roberto on behalf of the
Verts/ALE Group
Position of Pharma Deutschland
Manufacturers of class IIb and class III 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 undesirable side-effects, or
when otherwise necessary, including but
not limited to changes in the frequency or
severity of incidents or side effects,
following the occurrence of a serious
incident or identification of a new safety
signal, following the implementation of a
field safety corrective action, or when new
clinical or performance data becomes
available that may impact the evaluation of
safety or performance. The PSUR shall be
part of the technical documentation as
specified in Annex III.
Reject Amendment 583
Justification
The wording “or when otherwise necessary” is overly broad and does not provide sufficient legal
certainty. Combined with the expressly non-exhaustive list of potential triggers, it creates
considerable scope for interpretation by manufacturers, notified bodies and competent authorities.
The events listed are important elements of the post-market surveillance system. However, they do not
necessarily result in a significant change in the benefit-risk determination or in the assessment of a
device’s safety and performance. The proposed addition could therefore lead to unscheduled PSUR
updates being required solely on the basis of individual events, without first assessing their actual
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regulatory relevance. The trigger criteria already contained in the original wording are sufficient to
adequately capture safety-relevant changes.
Amendment 584 Article 86(1) subparagraph 2
Proposed by Tiemo Wölken Position of Pharma Deutschland
Manufacturers of class IIb and class III 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 undesirable side-effects.
Where the notified body has limited the
validity of a certificate in accordance with
Article 56(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. The
PSUR shall be part of the technical
documentation as specified in Annex III.;
Reject Amendment 584
Justification
The original proposal by the Commission introduces a risk-based and proportionate approach to PSUR
updates by providing for a two-year update interval following the initial certification. The proposed
exception in Amendment 584 for certificates with a limited validity period would partially undermine
this intended regulatory relief and reverse the intended reduction of the administrative burden. There
is no evidence that an annual PSUR update in all cases of limited certificate validity would provide
an additional benefit for patient’s or user’s safety.
Amendment 585 Article 86(1) subparagraph 2
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
(2) Manufacturers of implantable class IIb and
class III devices shall update the PSUR in the
first year after the certificate is issued and
every two years thereafter and when there is a
significant change in the benefit-risk
determination or in the acceptability of
Accept Amendment 585
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undesirable side-effects. The PSUR shall be
part of the technical documentation as
specified in Annex III.;
Justification
This amendment introduces a more proportionate and risk-based approach to the PSUR
requirements for non-implantable class IIb devices. Following an initial update within two years after
certification, further PSUR updates would only be required where justified by changes to the device’s
benefit-risk profile or to the acceptability of side effects. This reduces unnecessary regulatory burden
while ensuring that an appropriate level of surveillance is maintained for higher-risk devices.
Amendment 586 Article 86(1) subparagraph 3
Proposed by Ignazio Roberto Marino on behalf
of the Verts/ALE Group
Position of Pharma Deutschland
Manufacturers of class IIa devices shall
update the PSUR at least once in the first two
years after the certificate is issued, and
when necessary thereafter, including but not
limited to when there is a significant change
in the benefit-risk determination, in the
frequency or severity of incidents or side
effects, following the occurrence of a
serious incident or identification of a new
safety signal, following the implementation
of a field safety corrective action, or when
new clinical or performance data becomes
available that may impact the evaluation of
safety or performance of the device. The
PSURs shall be part of the technical
documentation specified in Annex III.;
Reject Amendment 586
Justification
The proposed extension of the trigger criteria creates considerable legal uncertainty. The expressly
non-exhaustive list of potential triggers significantly broadens the scope of the term “when necessary”.
The events listed are important elements of the post-market surveillance system. However, they do not
necessarily result in a change to the benefit-risk determination or to the safety and performance profile
of a device.
The proposed amendment therefore risks making PSUR updates necessary on the basis of individual
events alone, without first assessing their actual regulatory relevance. This would increase the
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administrative burden for manufacturers and substantially weaken the originally proposed risk-based
and proportionate approach.
If further clarification of the term "when necessary" is considered desirable, this should be addressed
through MDCG guidance rather than by expanding the legal trigger criteria in the MDR itself. Such an
approach would provide greater flexibility while preserving the proportionality intended by the
Commission’s proposal.
Amendment 587 Article 86(1) subparagraph 3
Valentina Palmisano Position of Pharma Deutschland
Manufacturers of class IIa devices shall
update the PSUR at least once in the first two
years after the certificate is issued and when
necessary, e.g. when there is a significant
change in the benefit-risk determination, in
the frequency or severity of incidents or side
effects, following the occurrence of a
serious incident or identification of a new
safety signal, following the implementation
of a field safety corrective action, or when
new clinical or performance data becomes
available that may impact the evaluation of
safety or performance of the device. The
PSURs shall be part of the technical
documentation specified in Annex III.;
Reject Amendment 587
Justification
The proposed extension of the trigger criteria creates considerable legal uncertainty. The expressly
non-exhaustive list of potential triggers significantly broadens the scope of the term “when necessary”.
The events listed are important elements of the post-market surveillance system. However, they do not
necessarily result in a change to the benefit-risk determination or to the safety and performance profile
of a device.
The proposed amendment therefore risks making PSUR updates necessary on the basis of individual
events alone, without first assessing their actual regulatory relevance. This would increase the
administrative burden for manufacturers and substantially weaken the originally proposed risk-based
and proportionate approach.
If further clarification of the term "when necessary" is considered desirable, this should be addressed
through MDCG guidance rather than by expanding the legal trigger criteria in the MDR itself. Such an
approach would provide greater flexibility while preserving the proportionality intended by the
Commission’s proposal.
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Amendment 588 Article 86(1) subparagraph 3
Proposed by Ruggero Razza, Michele Picaro Position of Pharma Deutschland
Manufacturers of non-implantable class IIa
and class IIb devices shall update the PSUR at
least once within two years following the
issuance of the certificate and when
necessary on the basis of a significant
change in the benefit-risk balance or in the
acceptability of undesirable side-effects.
The PSURs shall be part of the technical
documentation specified in Annex III.
Reject Amendment 588
Justification
Compared to the Commission proposal, the amendment creates an additional regulatory burden,
as manufacturers of non-implantable class IIa and class IIb devices would be required to update the
PSUR at least once within the first two years after certification, regardless of whether any specific safety
or performance concerns have arisen.
While the Commission proposal requires manufacturers to update the PSUR only when necessary on
the basis of a significant change in the benefit-risk determination or in the acceptability of undesirable
side effects, the amendment introduces an additional mandatory update requirement.
In particular, for devices with a stable safety and performance profile, it is questionable whether a
routine update within the first two years would provide any additional benefit for patient safety. By
contrast, it would generate additional administrative burdens for manufacturers and notified bodies
without a corresponding improvement in the level of protection of health and safety.
The Commission proposal therefore represents a more proportionate and risk-based approach and
should be retained.
Amendment 589 Article 86(2a)
Proposed by Kateřina Konečná Position of Pharma Deutschland
(2a) For class IIb and class III devices, other
than custom-made, investigational and
well-established technology devices, the
manufacturer shall make publicly available
through Eudamed, in a structured format, a
summary of the main findings of each
Reject Amendment 589
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periodic safety update report referred to in
paragraph 1.
The summary shall be published no later
than 30 days after finalisation of the PSUR
and, in any event, no later than 120 days
after the end of the reporting period to which
the PSUR relates. Where review by a notified
body is required pursuant to paragraph 2 and
has not been completed before publication,
the summary shall indicate that the notified
body review is pending and shall be
updated, where necessary, no later than 30
days after completion of that review.
The Commission shall, by means of
implementing acts, specify the format and
minimum content of the summary. The
minimum content shall include:
(a) any safety or performance concerns
identified during the reporting period;
(b) a description of any corrective or
preventive actions taken and their
outcomes;
(c) the main findings of post-market clinical
follow-up conducted during the reporting
period; and
(d) the manufacturer's conclusion on
whether the benefit-risk profile of the
device remains acceptable.
Those implementing acts shall be adopted
in accordance with the examination
procedure referred to in Article 114(3).;
Justification
The obligation to publish a summary of the PSUR findings in EUDAMED would create a significant
additional administrative burden for manufacturers. Furthermore, there is a risk that confidential
information relating to safety assessments, PMCF findings and corrective actions could become
publicly accessible, thereby adversely affecting legitimate business interests.
The added value of this new transparency requirement compared with the transparency mechanisms
already provided for under the MDR has not been sufficiently demonstrated. Before introducing such
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an obligation, its benefits, proportionality and the protection of confidential business information
should be carefully balanced.
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▪ Evaluation of devices suspected of presenting an unacceptable risk or other non-
compliance
Article 94
Article 94 lays down the procedure for the evaluation of devices suspected of presenting an
unacceptable risk or other non-compliance with the MDR. The Commission‘s proposal expands
the scope of this provision in several respects. First, it extends the evaluation not only to the
device concerned but also to the economic operator. Second, it requires, where applicable and
upon request, the notified body that issued the certificate for the device to cooperate with
competent authorities during the evaluation. Third, the proposal introduces an explicit power for
competent authorities to request documentation from economic operators and notified bodies
where such documentation is necessary in the interest of public health or patient safety. In
addition, the proposal expressly provides for cooperation between competent authorities of
different Member States when carrying out evaluations under Article 94.
The Draft Report of the Committee on Public Health of the European Parliament does not
propose any amendments to this provision. One amendment concerning Article 94 has been
submitted.
Amendment 600 Article 94(2)
Proposed by Laurent Castillo, Margarita de la
Pisa Carrión, Ondřej Knotek, Marie-Luce
Brasier Clain, Valérie Deloge
Position of Pharma Deutschland
The relevant economic operators and, where
applicable and requested, the notified body
that issued a certificate for the device in
question shall cooperate with the competent
authorities. Before concluding the
assessment, the competent authorities
shall report their preliminary conclusions to
the economic operator concerned and give
it the opportunity to submit observations or
additional technical information, except
where immediate action is necessary to
remedy a significant risk to health or safety.
Accept Amendment 600
Justification
Amendment 600 strengthens procedural fairness and transparency during market surveillance
evaluations under Article 94. Before reaching a final conclusion, competent authorities should provide
the economic operator concerned with their preliminary findings and give it the opportunity to submit
observations, clarifications or additional technical information. This helps ensure that decisions are
based on a complete and accurate assessment of all relevant facts and evidence.
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The proposed right to be heard enhances legal certainty and is consistent with the principles of good
administration and due process. It may also help avoid unnecessary regulatory measures where
additional information provided by the economic operator resolves the concerns identified during the
evaluation.
The exception for situations where immediate action is necessary to remedy a significant risk to health
or safety is appropriate and ensures that urgent public health concerns can continue to be addressed
without delay.
The clarification made in Amendment 273 that a product’s regulatory status should not, in and of
itself, constitute evidence of an unacceptable risk is appropriate. The regulatory status of a product
and the risks posed by that product are distinct issues and should not be conflated. This clarification
should therefore be added in Article 94.
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▪ Support by the EMA
Article 106b
Since 2022, the EMA has provided the secretariat for the expert panels. The Commission’s
proposal includes support from the EMA to the competent authorities to “improve” coordination
between them, especially with regard to borderline cases and classification issues, derogations
from applicable conformity assessment procedures and possibly other requirements, clinical
evaluations and investigations, vigilance and market surveillance. The Draft Report of the
Committee on Public Health of the European Parliament does not propose any amendments
to this provision. Several amendments have been submitted concerning this provision
(Amendments 619 ff.).
Amendments 619 and 620 Article 106b
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo, by
Ruggero Razza, Michele Picaro
Position of Pharma Deutschland
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:
Accept Amendments 619 and 620
Justification
Limiting the EMA's role to administrative support is appropriate and is welcomed. Removing the
references to scientific and technical support helps to ensure a clear allocation of responsibilities and
avoids any perception that the EMA may influence regulatory qualification decisions in areas beyond
its primary field of competence. This is particularly important for substance-based medical devices
and other complex borderline products.
Restricting the EMA's role to administrative support therefore contributes to legal certainty, preserves
the existing regulatory framework and avoids unnecessary overlap of responsibilities.
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Amendments 621 and 622
Article 106b
The amendment document incorrectly refers to
Article 106a. The proposed amendments concern
the newly introduced Article 106b (Support by the
EMA) and the references should be corrected
accordingly to ensure consistency and legal
clarity.
Proposed by Ruggero Razza, Michele Picaro
and by Letizia Moratti, Dolors Montserrat,
Elena Nevado del Campo
Position of Pharma Deutschland
Deletion of Article 106b(1a) Accept Amendments 621 and 622
Justification
The Commission proposal would assign the EMA a role in supporting decisions on the regulatory status
and classification of products. The deletion of this provision is welcomed.
The EMA's primary mandate and expertise relate to medicinal products. Removing this provision
contributes to legal certainty, preserves a clear distribution of responsibilities and avoids unnecessary
overlap between the regulatory systems for medicinal products and medical devices.
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▪ Annex VIII - Classification Rules
Rule 11
Classification Rule 11 has been amended in the Commission’s proposal with the aim of assigning
lower risk classes to software. This objective is very welcome. However, the proposed revision of
Rule 11 does not achieve its stated goal of simplification. On the contrary, it risks increasing legal
uncertainty and may ultimately discourage innovation in digital health solutions within the EU
market. The proposed amendments in the Draft Report of the Committee on Public Health of
the European Parliament (Amendments 117, 118, 119 and 120) are not achieving the
objective of simplification and proportionality. Several amendments concerning Rule 11
have been submitted (Amendments 807 ff.).
Amendment 807 Annex VIII – Section 6.3. Rule 11
Proposed by Sirpa Pietikäinen Position of Pharma Deutschland
A medical device 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:
- 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,
Partially accept Amendment 807
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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.
Justification
This proposal restores a genuine class I pathway for low-risk treatment software that does not require
clinical management, consistent with the default classification rule in Annex I, point 6.6(g). The
proposed approach ensures that low-impact treatment-support software is not subject to
disproportionate regulatory requirements, while preserving a cautious classification in line with
established risk-based classification principles, including the IMDRF framework. The proposal is
largely inspired by the amendments included in the Draft Report of the Committee on Public Health of
the European Parliament.
Furthermore, the reference to a "simple calculator" should be deleted. The inclusion of a specific
example in a classification rule risks creating uncertainty regarding the scope of the provision and may
lead to arguments a contrario for software not covered by that example. Rule 11 should establish clear,
technology-neutral and future-proof classification criteria rather than referring to specific software
types. Given the rapid evolution of digital health technologies, classification should be based on the
intended purpose and the risks posed by the software, rather than on illustrative examples that may
become outdated or lead to inconsistent interpretation. Any illustrative examples should be included
in MDCG guidance documents rather than in the classification rule itself. This would allow greater
flexibility and facilitate future updates without requiring legislative amendments. This approach is also
consistent with international regulatory practice. For example, the MHRA guidance treats simple
calculators in a similar manner to that proposed in this amendment without embedding such examples
directly in the classification rule itself.
Among the proposed amendments, this approach provides the most balanced and proportionate
solution for the classification of medical device software.
Amendment 808 Annex VIII – Section 6.3. Rule 11
Proposed by Andreas Glück, Stine Bosse, Billy
Kelleher
Position of Pharma Deutschland
Software which is intended to generate for a
medical purpose and generates an output
Reject Amendment 808
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that confers a clinical benefit and 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:
Note: two drafting corrections: deletion of the
duplicated wording "is used", and correction of the
typographical error "in one of the following
situations".
Justification
The addition of the reference to a medical purpose is unnecessary, as the classification rules in Annex
VIII apply only to products that already fulfil the definition of a medical device under Article 2 MDR. The
proposed wording is therefore redundant and does not provide additional legal clarity.
Editorial comments: The duplicated wording “is used” should be deleted and the wording should be
corrected to read "in one of the following situations" instead of "in on of the following situations".
This amendment is substantively similar to Amendment 810 and pursues the same objective. Both
amendments should be rejected.
Amendment 809 Annex VIII – Section 6.3. Rule 11
Proposed by Tiemo Wölken Position of Pharma Deutschland
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:
Accept Amendment 809
Justification
The proposed wording improves the readability and clarity of Rule 11 by removing the phrase "for a
disease or condition", which is already repeated and further specified in the subsequent bullet points.
The amendment does not alter the substance of the classification rule but contributes to a clearer and
more coherent drafting of the provision. Improved readability helps reduce the risk of divergent
interpretations and supports the consistent application of Rule 11 across the Union.
While this amendment improves the drafting of the provision, Amendment 807 remains the preferred
option from the perspective of Pharma Deutschland, as it better ensures a proportionate
classification of software based on the level of risk and intended purpose.
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Amendment 810 Annex VIII – Section 6.3. Rule 11
Proposed by Aurelijus Veryga Position of Pharma Deutschland
Software which is intended for a medical
purpose and to generates 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 its
output is intended for a disease or condition:
Reject Amendment 810
Note: two drafting corrections: “to generate”
instead of “to generates” and delete “the” before
“its output”
Justification
The addition of the reference to a medical purpose is unnecessary, as the classification rules in Annex
VIII apply only to products that already fulfil the definition of a medical device under Article 2 MDR. The
proposed wording is therefore redundant and does not provide additional legal clarity.
Editorial comments: The wording should be corrected to read "to generate" instead of "to generates"
and the wording “the” should be deleted before “its output”.
This amendment is substantively similar to Amendment 808 and pursues the same objective. Both
amendments should be rejected.
Amendment 811 Annex VIII – Section 6.3. Rule 11
Proposed by Ondřej Knotek, Laurent Castillo,
Marie-Luce Brasier-Clain, Viktória Ferenc,
Valérie Deloge
Position of Pharma Deutschland
Software which is intended for medical
purpose and generates 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 its output is
intended for a disease or condition:
Reject Amendment 811
Justification
The addition of the reference to a medical purpose is unnecessary, as the classification rules in Annex
VIII apply only to products that already fulfil the definition of a medical device under Article 2 MDR. The
proposed wording is therefore redundant and does not provide additional legal clarity.
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Amendment 812 Annex VIII – Section 6.3. Rule 11
Proposed by Andreas Glück, Stine Bosse, Billy
Kelleher
Position of Pharma Deutschland
– to treat or diagnose 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;
Refuse Amendment 812
Justification
Acceptance of this Amendment only makes sense if Amendment 808 is also accepted. Otherwise, the
reference to a "disease or condition" would be removed from the provision, potentially affecting the
clarity of the regulatory scope.
Furthermore, the deletion of the wording "is classified as" is not supported. This wording is
consistently used throughout the MDR classification rules and contributes to legal certainty and
drafting consistency. It should therefore be retained.
Amendment 813 Annex VIII – Section 6.3. Rule 11
Proposed by Tiemo Wölken Position of Pharma Deutschland
– to treat or diagnose a disease or condition
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;
Accept Amendment 813
Justification
The proposed wording improves the clarity and readability of Rule 11.
While this amendment improves the drafting of the provision, Amendment 807 remains the preferred
option from the perspective of Pharma Deutschland, as it better ensures a proportionate
classification of software based on the level of risk and intended purpose.
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Amendment 814 Annex VIII – Section 6.3. Rule 11
Proposed by Andreas Glück, Stine Bosse, Billy
Kelleher
Position of Pharma Deutschland
– to treat or diagnose 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;
Reject Amendment 814
Justification
Acceptance of this Amendment only makes sense if Amendment 808 is also accepted. Otherwise, the
reference to a "disease or condition" would be removed from the provision, potentially affecting the
clarity of the regulatory scope.
Furthermore, the deletion of the wording "is classified as" is not supported. This wording is
consistently used throughout the MDR classification rules and contributes to legal certainty and
drafting consistency. It should therefore be retained.
Amendment 815 Annex VIII – Section 6.3. Rule 11
Proposed by Tiemo Wölken Position of Pharma Deutschland
– to threat or diagnose a disease or condition
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 of a disease or
condition in a critical situation, in which cases
it is classified as class IIb;
Accept Amendment 815 (subject to a drafting
correction: “treat” instead of “threat”).
Justification
The proposed wording improves the clarity and readability of Rule 11.
Editorial comment: The wording should be corrected to read "treat" instead of "threat".
While this amendment improves the drafting of the provision, Amendment 807 remains the preferred
option from the perspective of Pharma Deutschland, as it better ensures a proportionate
classification of software based on the level of risk and intended purpose.
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Amendment 816 Annex VIII – Section 6.3. Rule 11
Proposed by Tiemo Wölken Position of Pharma Deutschland
– 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 or serious situation, in which cases it is
classified as class IIa;
Partially accept Amendment 816
Justification
The default class I classification introduced by the revised Rule 11 should retain a genuine
scope of application and should not be rendered ineffective by the subsequent classification
criteria.
As currently drafted, the categories of critical, serious and non-serious situations cover all
possible use cases. As a consequence, even low-risk software intended to treat or diagnose a
disease or condition in a non-serious situation would automatically fall within class IIa. This
risks undermining the proportionality objective pursued by the Commission.
The examples of software supporting dyscalculia exercises or motion-sickness training
illustrate that certain low-risk treatment-support applications neither require clinical
management nor present risks comparable to software currently classified in higher risk
classes. Subjecting such software to notified body involvement would create disproportionate
regulatory burdens without a corresponding benefit for patient safety.
The amendment therefore highlights an important issue. Pharma Deutschland considers that
a further clarification is necessary to distinguish software used to treat or diagnose a disease
or condition in a non-serious situation where clinical management is required from low-risk
software that does not require clinical management. Such a clarification would better align
Rule 11 with the risk-based approach of the MDR, maintain a meaningful class I pathway for
low-risk software and support innovation in digital health technologies.
Amendment 807 remains the preferred option from the perspective of Pharma
Deutschland, as it better ensures a proportionate classification of software based on the level
of risk and intended purpose.
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Amendment 817 Annex VIII – Section 6.3. Rule 11
Proposed by Andreas Glück, Stine Bosse, Billy
Kelleher
Position of Pharma Deutschland
– to treat or diagnose 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;
Reject Amendment 817
Justification
Acceptance of this Amendment only makes sense if Amendment 808 is also accepted. Otherwise, the
reference to a "disease or condition" would be removed from the provision, potentially affecting the
clarity of the regulatory scope.
The default class I classification introduced by the revised Rule 11 should retain a genuine scope of
application and should not be rendered ineffective by the subsequent classification criteria.
As currently drafted, the categories of critical, serious and non-serious situations cover all possible use
cases. As a consequence, even low-risk software intended to treat or diagnose a disease or condition
in a non-serious situation would automatically fall within class IIa. This risks undermining the
proportionality objective pursued by the Commission.
The examples of software supporting dyscalculia exercises or motion-sickness training illustrate that
certain low-risk treatment-support applications neither require clinical management nor present risks
comparable to software currently classified in higher risk classes. Subjecting such software to notified
body involvement would create disproportionate regulatory burdens without a corresponding benefit
for patient safety.
The amendment therefore highlights an important issue. Pharma Deutschland considers that a further
clarification is necessary to distinguish software used to treat or diagnose a disease or condition in a
non-serious situation where clinical management is required from low-risk software that does not
require clinical management. Such a clarification would better align Rule 11 with the risk-based
approach of the MDR, maintain a meaningful class I pathway for low-risk software and support
innovation in digital health technologies.
Amendment 807 remains the preferred option from the perspective of Pharma Deutschland, as it
better ensures a proportionate classification of software based on the level of risk and intended
purpose.
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▪ Annex VIII - Classification Rules
Rule 14
Classification Rule 14 has not been amended by the Commission proposal. Nonetheless,
practical challenges in interpreting this classification rule persist, which could be addressed by
refining and clarifying its wording.
The Draft Report of the Committee on Public Health of the European Parliament already
considers our proposal (Amendment 122). Amendment 818 also considers our proposal.
Amendment 818 Annex VIII – Section 7.1 Rule 14
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
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 have a clinically relevant ancillary
action contributing to that of the devices the
intended medical purpose, are classified as
class III
Accept Amendment 818
Justification
According to Recital (59) of the MDR, the objective of the regulation is to obtain a suitable risk-based
classification of devices. This should also be the case for products falling under Rule 14.
The classification rule should consider if the respective substance has an impact on the intended
medical purpose of the device. If this is not the case, it is not justifiable to classify those products
under the highest risk class.
To illustrate, many substance-based medical devices contain substances which, if used separately,
can be considered to be medicinal products. However, those substances present in the amount in
medical devices are not clinically relevant to the fulfilment of the intended medical purpose. An
example constitutes substances having merely the function to preserve the formulation and are
therefore used as preservatives, but do not contribute to the intended medical purpose.
However, these substances are currently sometimes considered as ancillary medicinal substances
without considering whether the substances are clinically relevant to achieve the intended medical
purpose with the effects that products containing them are incorrectly classified as Class III products
due to the wording of Classification Rule 14. As a result, this classification requires a disproportionate
amount of resources, bureaucracy and costs for manufacturers and Notified Bodies.
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▪ Annex VIII - Classification Rules
Rule 21
Per the Commission proposal, Rule 21 has been slightly modified with regard to its wording. In
particular, the terms “on or” have been added to the introductory sentence of this classification
rule.
The Draft Report of the Committee on Public Health of the European Parliament already
considers our proposal (Amendment 121). Amendment 819 also considers our proposal.
Amendment 819 Annex VIII – Section 7.8 Rule 21
Proposed by Letizia Moratti, Dolors
Montserrat, Elena Nevado del Campo
Position of Pharma Deutschland
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 on or in the human body are
classified as:
Accept Amendment 819
Justification
The proposal of the Commission would have the effect of bringing certain devices within the scope of
Rule 21 that are currently classified under other rules, in particular Rule 1, as class I devices. This
affects devices that are locally dispersed on the human body, such as electrode gel, ultrasound gel and
ultrasound cream. Currently, these devices are consistently classified as class I devices according to
MDCG Guidance 2021-24 Rev. 1 on classification.
Without a doubt, these devices are low-risk preparations. Reclassifying them from class I (Rule 1) to
class IIa (Rule 21) would be disproportionate to their actual risk posed. In addition, such products
would have to undergo a conformity assessment involving a notified body entailing significant
additional time and cost for manufacturers. In other words, the proposed change concerning Rule 21
would increase administrative burden, including costs, for manufacturers of these products rather than
reducing them.
Therefore, the wording of Rule 21 should be left unchanged.
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▪ Annex VIII - Classification Rules
Rules 6 and 7
Classification Rules 6 and 7 have been amended in the Commission’s proposal to clarify that
reusable surgical instruments should be classified as class I, regardless of the part of the body
with which they come into contact. This clarification is welcomed. However, it should be extended
to cover all surgical instruments and should not be limited to reusable instruments only. The Draft
Report of the Committee on Public Health of the European Parliament does not propose any
amendments to these provisions. Two amendments concerning Rules 6 and 7 have been
submitted (Amendments 820 f.).
Amendment 820 Annex VIII – Section 5.2 Rule 6
Proposed by Ondřej Dostál Position of Pharma Deutschland
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 reusable 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 or 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;
- 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
Accept Amendment 820
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application, in which case they are classified
as class IIb.
Justification
Under the current framework, a surgical instrument supplied sterile and intended for single use
is classified in a higher risk class (class IIa) than an otherwise identical device that is labelled as
reusable (class I) and therefore must be cleaned, disinfected and sterilised by the user prior to first
use and before each subsequent use. This differentiation is neither comprehensible nor risk-based and
leads to a contradictory regulatory outcome. Reuse of a device requires additional reprocessing steps
by the user and entails a higher risk of improper handling or contamination than a device that is
supplied sterile and intended for single use only.
The proposed change affects not only the Classification Rules 6 and 7 but also Annex VIII Chapter I Nr.
2.3 and the regulations for the conformity assessment in Article 52 (7, first paragraph).
Amendment 821 Annex VIII – Section 5.3 Rule 7
Proposed by Ondřej Dostál Position of Pharma Deutschland
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 or 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
ionizing radiation in which case they are classified
as class IIb;
- 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
Accept Amendment 821
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- are intended to administer medicines, in which
case they are classified as class IIb;
- are reusable surgical instruments regardless of
the body part with which they come into
contact, in which case they are classified as
class I;
Justification
Under the current framework, a surgical instrument supplied sterile and intended for single use
is classified in a higher risk class (class IIa) than an otherwise identical device that is labelled as
reusable (class I) and therefore must be cleaned, disinfected and sterilised by the user prior to first
use and before each subsequent use. This differentiation is neither comprehensible nor risk-based and
leads to a contradictory regulatory outcome. Reuse of a device requires additional reprocessing steps
by the user and entails a higher risk of improper handling or contamination than a device that is
supplied sterile and intended for single use only.
The proposed change affects not only the Classification Rules 6 and 7 but also Annex VIII Chapter I Nr.
2.3 and the regulations for the conformity assessment in Article 52 (7, first paragraph).
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▪ Annex XIV Part A – Clinical evaluation
Section 3
The European Commission proposed to introduce greater flexibility into the equivalence concept.
In particular, devices should be considered equivalent even where certain biological, technical or
clinical characteristics are not identical but merely similar. The objective of this approach is to
improve the practical applicability of equivalence and facilitate the use of existing clinical data.
The Draft Report of the Committee on Public Health of the European Parliament does not
propose any amendment to this provision. Three amendments concerning Annex XIV Part A
Section 3 have been submitted (Amendments 833 ff.).
Amendments 833, 834 and 835 Annex XIV Part A Section 3
Proposed by Ignazio Roberto on behalf of the
Verts/ALE Group, by Tiemo Wölken and by
Valentina Palmisano
Position of Pharma Deutschland
Deletion of proposed second and third indents
of Section 3 of Annex XIV Part A
Reject Amendments 833, 834 and 835
Justification
These amendments reject the more pragmatic and proportionate approach proposed by the European
Commission and seek to maintain the current MDR requirements. Under the proposed deletions, the
relevant technical, biological and clinical characteristics would continue to have to correspond to a
very high degree, thereby preserving the existing barriers to demonstrating equivalence.
As a result, manufacturers would continue to face significant practical difficulties when relying on
data from comparable devices, particularly where the equivalent device is manufactured by another
company. The concept of equivalence would remain of limited practical relevance and would only be
available in exceptional circumstances.
The Commission proposal, by contrast, would improve the usability of the equivalence pathway while
maintaining the requirement that equivalence be scientifically justified. This would reduce
unnecessary clinical investigations and administrative burden without diminishing the level of patient
protection.
The proposed deletions should therefore be rejected and the Commission's approach retained.
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▪ Subject matter and scope
Article 1(8)
Article 1(8) has not been amended neither by the Commission proposal nor by the Draft Report of
the Committee on Public Health of the European Parliament and the Amendments. However, the
Draft Report proposes an amendment to Rule 14 (Amendment 122), which Pharma
Deutschland fully supports. Since Article 1(8) establishes the concept of an ancillary medicinal
substance and Rule 14 governs the classification of medical devices incorporating such
substances, both provisions should be aligned to ensure legal certainty and consistent
application.
Commission Proposal Article 1(8)
Original Text Proposed Change
8. Any device which, when placed on the market
or put into service, incorporates, 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, 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
device, shall be assessed and authorised in
accordance with this Regulation.
8. Any device which, when placed on the market
or put into service, incorporates, 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, 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 clinically relevant
ancillary action in order to achieve the intended
medical purpose to that of the device shall be
assessed and authorised in accordance with this
Regulation.
Justification
Substance-based medical devices often contain substances which, if used separately, can be
considered to be medicinal products. However, the amounts of those substances present in
substance-based medical devices are often not clinically relevant to the fulfilment of the intended
medical purpose. An example constitutes substances having merely the function to preserve the
formulation and are therefore used as preservatives. Consequently, they do not contribute to the
intended medical purpose. This proposed change intends to clarify that a substance can only be
considered as an ancillary medicinal substance if it has a clinically relevant ancillary action in order to
achieve the intended medical purpose of the device.
This change must be read in conjunction with the proposed change to the classification Rule 14 further
below. The Draft Report of the Committee on Public Health of the European Parliament has
already include an amendment to Rule 14 (Amendment 122) and therefore our proposition would
align Article 1(8) with it, thereby enhancing legal certainty and ensuring consistent application of
these provisions.
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▪ Definitions
Article 2(7)
The European Commission proposes to amend the definition of the term “generic device group”
by replacing the current alternative conditions with cumulative ones. The Draft Report of the
Committee on Public Health of the European Parliament and the Amendments do not
propose any amendments to this provision. However, the existing definition is more
proportionate and better aligned with the regulatory objectives.
Commission Proposal Article 2(7)
Original Text Proposed Change
(7) ‘generic device group’ means a set of devices
having the same or similar intended purposes and
a commonality of technology allowing them to be
classified in a generic manner not reflecting
specific characteristics.
(7) ‘generic device group’ means a set of devices
having the same or similar intended purposes or
and a commonality of technology allowing them
to be classified in a generic manner not reflecting
specific characteristics.
Justification
Replacing alternative conditions with cumulative conditions narrows the scope of the definition set in
Article 2(7) and increases the internal homogeneity of the product group concerned. As a
consequence, this approach would lead to a larger number of products being subject to conformity
assessment activities under the applicable sampling plan.
The proposition would maintain the current provision of Article 2(7), which is based on alternative
conditions.
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▪ Certificate of free sale
Article 60
The European Commission has amended Article 60 by introducing a new paragraph 1b, which
establishes an obligation for competent authorities to publish certificates of free sale in
EUDAMED. The Draft Report of the Committee on Public Health of the European Parliament
does not propose any amendments to this provision. This additional requirement is critical and
raises significant concerns. No amendment concerning this provision have been submitted.
Commission Proposal Article 60(1b)
Original Text Proposed Change
1b. The competent authority shall make the
certificates of free sale issued in accordance with
paragraphs 1 and 1a publicly available in
Eudamed.
Deletion of the proposed Article 60(1b).
Justification
Certificates of free sale typically contain information on the manufacturer, the product trade name, the
Basic UDI-DI and the third country for which the certificate is issued.
The disclosure of the information contained in certificates of free sale does not provide any added
value for patient safety or public health. Moreover, trade relations with third countries shall fall
outside the scope and purpose of Eudamed.
Manufacturers have a legitimate interest in not disclosing sensitive information on their commercial
relationships with non-EU trade partners.
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▪ Other non-compliance
Article 97
Article 97 lays down provisions applicable in cases of “other non-compliances” concerning CE-
marked devices that do not present an unacceptable risk to the health or safety of patients, as
identified by national authorities in the course of their market surveillance activities.
From the perspective of legal certainty for manufacturers of CE-marked devices, as well as the
principles of proportionality and feasibility of corrective measures and the clear allocation of roles
and responsibilities between authorities and economic operators, the proposed amendments to
Article 97 raise concerns. In particular, they may give rise to divergent interpretations and
potentially conflict with the principles of the New Legislative Framework and the free movement
of goods within the European Union, notably in situations involving differing views on the
regulatory status or classification of a CE-marked device.
The Draft Report of the Committee on Public Health of the European Parliament does not
propose any amendments to this provision. No Amendment concerning this provision has
been submitted.
Commission Proposal Article 97
Original Text Proposed Change
1. Where, having performed an evaluation
pursuant to Article 94, the competent authorities
of a Member State find that a device or an
economic operator does not comply with the
requirements laid down in this Regulation but
does not present an unacceptable risk to the
health or safety of patients, users or other
persons, or to other aspects of the protection of
public health, they shall require the relevant
economic operator to bring the non-compliance
concerned to an end within a reasonable period
that is clearly defined and communicated to the
economic operator and that is proportionate to
the non-compliance.
2. Where the economic operator does not bring
the non-compliance to an end within the period
1. Where, having performed an evaluation
pursuant to Article 94, the competent authorities
of a Member State find that a device or an
economic operator does not comply with the
requirements laid down in this Regulation but
does not present an unacceptable risk to the
health or safety of patients, users or other
persons, or to other aspects of the protection of
public health, they shall require the relevant
economic operator to bring the non-compliance
concerned to an end within a reasonable period
that is clearly defined and communicated to the
economic operator and that is proportionate to
the non-compliance. The assessment of
compliance shall take due account of the
respective roles and responsibilities of
economic operators as set out in Articles 10, 11,
13, 14 and 16. In the case of device-related
non-compliances, the relevant economic
operator shall be the manufacturer.
2. Where the economic operator does not bring
the non-compliance to an end within the period
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referred to in paragraph 1, the Member State
concerned shall, without delay, take all
appropriate measures to restrict or prohibit the
product being made available on the national
market or to ensure that it is recalled or withdrawn
from the national market. That Member State shall
inform the Commission and the other Member
States, without delay, of those measures, by
means of the electronic system referred to in
Article 100.
2a. The economic operator shall take any
appropriate corrective action pursuant to
paragraph 1 or 2 throughout the Union in respect
of all the devices concerned that they have made
available on the market, unless a competent
authority takes other appropriate measures.
referred to in paragraph 1, the Member State
concerned shall, where the non-compliance
relates to the device, and after consulting the
competent authority responsible for the
manufacturer, without delay, take all appropriate
measures to restrict or prohibit the product being
made available on the national market or to
ensure that it is recalled or withdrawn from the
national market. That Member State shall inform
the Commission and the other Member States,
without delay, of those measures, by means of the
electronic system referred to in Article 100.
2a. The economic operator shall take any
appropriate corrective action pursuant to
paragraph 1 or 2 throughout the Union in respect
of all the devices concerned that they have made
available on the market, unless a competent
authority takes other appropriate measures.
3. By way of derogation from paragraphs 1 and
2, where a competent authority holds a
dissenting view on the regulatory status or the
classification of a CE‑marked device, it shall
follow the procedures laid down in Articles 4
and 51b of this Regulation. Pending the
outcome of those procedures, the free
movement of the CE‑marked device shall
remain protected in accordance with Article 24
of this Regulation.
4. In order to ensure the uniform application of this
Article, the Commission may, by means of
implementing acts, specify appropriate measures
to be taken by competent authorities to address
given types of non-compliance. Those
implementing acts shall be adopted in
accordance with the examination procedure
referred to in Article 114(3).
Justification
It is acknowledged that market surveillance activities may include an assessment of the regulatory
status or classification of a CE-marked device. However, in light of the CE marking and the protection
of the free movement of goods pursuant to Article 24, measures restricting or prohibiting the making
available of a device on the market, or requiring its recall or withdrawal, must remain the
responsibility of the competent authority of the manufacturer. This applies insofar as the device
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does not present an unacceptable risk to the health or safety of patients that would justify immediate
action by other national authorities.
Where a national authority holds a dissenting view on the regulatory status or classification of a
CE-marked device, and where no consensus can be reached following consultation with the
manufacturer and its competent authority, the national authority may initiate the applicable legal
procedures for the determination of the regulatory status in accordance with Article 4 and, where
relevant, for the determination of the classification under Article 51b.
By contrast, where a product has already been classified as a device and bears a CE-marking in another
Member State, a national authority must first apply the procedures laid down in the legal framework for
medical devices before applying classification procedures under other Union legislation (see judgment
of the European Court of Justice of 3 October 2013, Case C-109/12). Any national measure taken
without a transparent and objective procedure in accordance with Article 4 (and by analogy Article
51ff.) would therefore be contrary to the case law of the Court and would infringe the manufacturer’s
rights under the principle of the free movement of goods.
Finally, with regard to proportionality, it must be emphasised that the application of Article 97
presupposes that the CE-marked device concerned does not present an unacceptable risk to health or
safety. Where such a risk exists, Article 95 applies. Consequently, in the absence of a safety concern,
there is no justification for immediate national measures without awaiting the outcome of the
legal procedures provided for under Articles 4 and 51 ff.
14.09.2026
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