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Pharma Deutschland e. V.
info@pharmadeutschland.de
www.pharmadeutschland.de
BRÜSSEL
Rue Marie de Bourgogne 58
1000 Brüssel
T. +49-170-6133687
1
Position of Pharma Deutschland e.V. 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: 30 April 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 Commission’s 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.
The majority of the measures proposed by the European Commission are suitable for simplifying
procedures, increasing predictability, and reducing administrative burdens, without compromising the
high level of patient safety, and should therefore be retained. These include in particular:
• abolition of the maximum validity period of conformity certificates,
• facilitation of the conformity assessment procedure,
• establishment of a structured dialogue,
• support for micro, small and medium-sized enterprises,
• digitalisation,
• facilitations in the field of vigilance,
• facilitations in the field of clinical evaluation,
• provisions for Well-Established Technology Devices (WET),
• establishment of regulatory sandboxes.
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Need for further improvements and addressing unresolved issues under the MDR
Nevertheless, several areas require further improvement. The following analysis focuses on those
proposed changes that are of greatest relevance and necessity for Pharma Deutschland
members, namely manufacturers of substance‑based medical devices, dental medical devices
and software.
The sections below set out specific topics and elements of the proposal that would benefit from
further refinement. Pharma Deutschland therefore proposes amendments to the following legal
provisions:
• Article 1 (8) – Subject matter and scope
• Article 2 – Definitions
• Article 4 – Regulatory Status of Products
• Article 4a – Opinion on and determination of the regulatory status of a product
• Article 10 – General obligations of manufacturers
• Article 15 – Person responsible for regulatory compliance
• Article 60 – Certificate of free sale
• Article 97 – Other non-compliance
• Article 106 – Expert panels
• Article 106b – Support by the EMA
• Annex I – Requirements regarding the information supplied with the device
• Annex VI – Information to be submitted upon the registration of devices and
economic operators in accordance with articles 29(4) and 31, and core data elements
to be provided to the UDI database together with the UDI-DI in accordance with
articles 28 and 29, and the UDI system
• Annex VIII – Classification Rules
- Rules 6 and 7
- Rule 11
- Rule 14
- Rule 21
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▪ Subject matter and scope
Article 1(8)
Article 1(8) has not been amended by the Commission proposal. This provision sets out the
concept of ancillary medicinal substances and is, therefore, linked to Classification Rule 14 that
is applicable to medical devices incorporating an ancillary medicinal substance. As also
explained further below on the Classification Rule 14 practical challenges in interpreting this
classification rule persist, notably when it comes to the determination of an ancillary medicinal
substance.
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.
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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 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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▪ 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.
Commission Proposal Article 2(72)
Original Text Proposed Change
(72) ‘well-established technology device’ means a
device that belongs to a generic device group,
which fulfils the following criteria:
a) it has simple, common and stable design;
b) it has not been associated with safety issues in
the past;
c) it has well-known clinical performance
characteristics and comprises standard of
care devices with little evolution in indications
and the state of the art;
d) it has a long history on the Union market;’
(72) ‘well-established technology device’ means a
device that belongs to a generic device group,
which fulfils the following criteria:
a) it has simple, common and stable design;
b) it has a well-known safety history not been
associated with safety issues in the past;
c) it has well-known clinical performance
characteristics and comprises standard of
care devices with little evolution in indications
and the state of the art;
d) it has a long history on the Union market;’
Justification
It is proportionate and appropriate to extend the regulatory simplifications to all devices that
demonstrably qualify as well-established technology device independent of the risk class. This
proposal reflects their proven clinical performance, safety and low-risk profile. This approach would
enhance regulatory efficiency while maintaining high standards of patient safety.
However, the term “safety issues” is not defined in the Regulation, which may lead to divergent
interpretations by notified bodies.
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▪ Regulatory 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.
Commission Proposal Article 4
Original Text Proposed Change
Regulatory Status of Products
1. The competent authorities of the Member
States shall coordinate their activities when
determining whether a specific product, or
category, or group of products, falls within the
definition of ‘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.
2. The Member States shall ensure an appropriate
level of consultation of the relevant competent
authorities of the Member States in the fields of in
vitro diagnostic medical devices, medicinal
products, substances of human origin (SoHO),
biocides, food products, cosmetics or other
products subject to Union legislation, where the
determination of whether a product has the
regulatory status of a device involves aspects
concerning the borderline with any of those types
of products. If that is the case, Member States
shall also ensure an appropriate level of
consultation of the relevant advisory or regulatory
bodies established in the relevant Union
legislation, such as the European Medicines
Agency (EMA), the SoHO Coordination Board, the
European Chemicals Agency (ECHA) and the
European Food Safety Authority (EFSA).
Deletion of proposed Article 4
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3. Where a competent authority of a Member
State, after having performed an evaluation in
accordance with Article 94, considers 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.
4. Where a competent authority of a Member State
raises 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 give
utmost consideration to the opinion of that expert
panel.
5. The results of the coordination activities of the
competent authorities in accordance with this
Article and the opinions of the expert panel
delivered in accordance with paragraph 4 of this
Article and Article 4a(2) shall be made publicly
available, without disclosing any confidential
information as referred to in Article 109.
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).
Justification
The reform proposal appears to seek to legally entrench the so-called Helsinki procedure, a decision-
making mechanism characterized by limited transparency and an insufficient scientific basis.
The formally structured procedure proposed in the revised version of Articles 4 and 4a is highly
questionable, as a decision on the regulatory status of a product initiated by a single competent
authority becomes decisive unless another authority of a Member State raises a substantiated
objection.
Particularly critical is the new proposed provision in Article 4(3), which allows Member States to adopt
measures affecting the regulatory status of products that already bear the CE marking. This
significantly relativizes the principle of free movement of goods enshrined in Article 24 MDR, the Blue
Guide as well as Articles 34 and 36 TFEU and undermines legal certainty and legitimate expectations.
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In the absence of clearly defined substantive criteria, procedural safeguards and effective
mechanisms for the protection of vested rights, there is a substantial risk that individual national
decisions may de facto undermine EU-wide market access.
Moreover, the specific wording of the new provisions raises fundamental questions regarding the role
and legal effect of the expert panels referred to in the proposed Article 106. The risk of divergent
assessments under identical EU-wide conditions is therefore not fully eliminated, particularly since
there is no obligation to apply the procedures set out in proposed Articles 4 and 4a. As a result, the
intended strengthening of legal certainty is unlikely to be achieved in practice. In addition, unresolved
issues remain regarding technical coverage and the long-term availability of sufficient expertise,
especially for complex demarcation and classification questions. In this context, the mandatory
involvement according to proposed Article 4(2) of other European bodies (e.g. EMA, ECHA or EFSA)
does not remedy the structural deficit resulting from the lack of systematic involvement of independent
scientific, technical and industry expertise, which may lead to isolated and inconsistent outcomes.
Proposed Article 4(6) MDR grants the European Commission the power to specify, by means of
implementing acts, the procedure, including binding deadlines, for the coordination and demarcation
mechanisms referred to in proposed Articles 4(1) to (4) and proposed Article 4a. While this allocation
of powers would be welcome in principle, the general procedural framework already reflects key
elements of the Helsinki procedure, which has been subject to justified criticism. Moreover, there is a
risk that, despite formal legal restructuring, the demarcation process will continue in practice to be
marked by delays, isolated positions and divergent national approaches.
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▪ Opinion on and determination of the regulatory status of a product
Article 4a
The analysis of the proposed Article 4 also applies for the proposed Article 4a.
Furthermore, although the decision-making process appears to be more closely aligned with
democratic principles, the mandatory involvement of industry experts remains absent. Such
expertise could provide essential technical and scientific input to the assessment. The possible
involvement of the newly established expert panels cannot adequately compensate for this
structural deficit.
At least the procedure concludes with the adoption of a formal legal act.
Commission Proposal Article 4a
Original Text Proposed Change
Opinion on and determination of the regulatory
status of a product
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.
2. The expert panel shall provide its opinion
without undue delay. The requester shall give
utmost consideration to the opinion of the expert
panel.
3. Having regard to the expert panel opinion
referred to in paragraph 2 or in Article 4(4), a
Member State may submit a substantiated
request to the Commission to determine whether
a specific product, or category or group of
products, falls within the definitions of ‘medical
Opinion on and determination of the regulatory
status of a product
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.
2. (proposed Article 4(3)) Where a competent
authority of a Member State, after having
performed an evaluation in accordance with
Article 94, considers 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 authority of the Member
State where the manufacturer or the authorized
representative has its registered place of
business and the manufacturer other Member
States regarding its envisaged measure
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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.
4. This Article shall not apply where within the
framework of another Union legislation the
regulatory status of the product, or category or
group of products concerned has been
determined as falling within the scope of that
other Union legislation, or where a procedure for
the determination of the regulatory status is
ongoing within the framework of another Union
legislation.
determining the justification on the regulatory
status of the product in question, before
submitting a substantiated request for an
opinion of an expert panel as referred to in
paragraph 1. The competent authority of the
Member State where the manufacturer or the
authorized representative has its registered
place of business and the manufacturer shall
provide their justifications within 30 days.
3. (proposed Article 4(2))The Member States
expert panel shall ensure an appropriate level of
consultation of the relevant competent
authorities of the Member States in the fields of in
vitro diagnostic medical devices, medicinal
products, substances of human origin (SoHO),
biocides, food products, cosmetics or other
products subject to Union legislation, where the
determination of whether a product has the
regulatory status of a device involves aspects
concerning the borderline with any of those types
of products. If that is the case, Member States the
expert panel shall also ensure an appropriate
level of consultation of the relevant advisory or
regulatory bodies established in the relevant
Union legislation, such as the European
Medicines Agency (EMA), the SoHO Coordination
Board, the European Chemicals Agency (ECHA)
and the European Food Safety Authority (EFSA).
The expert panel shall consult if applicable the
notified body, the manufacturer and the
developer of the product concerned.
4. (proposed Article 4a(2)) The expert panel shall
provide its opinion within 30 days without undue
delay. The requester shall give utmost
consideration to the opinion of the expert panel.
(proposed Article 4a(4)) 4. This Article shall not
apply where within the framework of another
Union legislation the regulatory status of the
product, or category or group of products,
concerned has been determined as falling within
the scope of that other Union legislation or where
a procedure for the determination of the
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regulatory status is ongoing within the framework
of another Union legislation.
5. (proposed Article 4(5)) The results of the
coordination activities of the competent
authorities in accordance with this Article and The
opinions of the expert panel delivered in
accordance with paragraph 4 of this Article and
Article 4a(2) shall be made publicly available,
without disclosing any confidential information as
referred to in Article 109.
6. (proposed Article 4a(3)) Having regard to the
expert panel opinion referred to in paragraph 4 2 or
in Article 4(4), a Member State requester as
referred in paragraph 1 may submit a
substantiated request to the Commission to
determine 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.
The Commission shall decide on the
substantiated request of the requester 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.
Justification
The following assumptions are necessary to ensure legal certainty for manufacturers, to enable their
willingness to place devices on the market, and to guarantee the availability of devices on the Union
market:
• Apart from a decision of the Commission adopted by means of an implementing act, only the
competent authority of the Member State in which the manufacturer has its registered place of
business should be empowered to determine the regulatory status of a product of that
manufacturer.
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• The free movement of CE-marked medical devices must be safeguarded, as guaranteed by
Article 24 MDR, the Blue Guide as well as Articles 34 and 36 TFEU.
• National authorities responsible for market surveillance in Member States where a CE-marked
device is merely distributed should be empowered to carry out market surveillance activities in
accordance with Article 93 ff. MDR. Any concerns regarding the correct regulatory status of a
CE-marked device should be referred to the Commission by means of a duly substantiated
request after opinion of an expert panel or to the Member State in which the manufacturer has
its registered place of business.
• Expert panels should demonstrate proven and up-to-date clinical, scientific, technical or
regulatory expertise in the field of medical devices, as well as impartiality, objectivity and
transparency. For the determination of the regulatory status of products, it must be ensured
that the expert panel has access to all relevant information necessary to fulfil its tasks. This
includes, in particular, information provided by the manufacturer and, if applicable, the
manufacturers of equivalent CE marked devices, who possesses the most comprehensive
knowledge of the products concerned.
• The expert panel should also assess whether a previous determination of a product, and the
underlying reasoning of such a determination by authorities or administrative or civil courts,
remains applicable under the current and amended Union legislation.
An amendment would also be necessary to Recital 11.
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▪ General obligations of manufacturers
Article 10
Article 10 sets out the general obligations of manufacturers and specifies, in paragraph 11, the
language requirements for the information to be provided by the manufacturer. It provides that
such information must be supplied in the official language(s) determined by the Member State in
which the device is made available. However, this provision does not distinguish between
information intended for lay users and information intended for professional users.
Commission Proposal Article 10(11)
Original Text Proposed Change
11. Manufacturers shall ensure that the device is
accompanied by the information set out in
Section 23 of Annex I in an official Union
language(s) determined by the Member State in
which the device is made available to the user or
patient. The particulars on the label shall be
indelible, easily legible and clearly
comprehensible to the intended user or patient.
When determining the official language of the
Union in which the information set out in Section
23 of Annex I or other information to be provided
by the manufacturer shall be made available,
Member States shall consider accepting another
official language of the Union in which the
information is made available, taking into
consideration the technical knowledge,
experience, education or training of the average
intended user(s).
11. Manufacturers shall ensure that the device is
accompanied by the information set out in
Section 23 of Annex I in an official Union
language(s) determined by the Member State in
which the device is made available to the user or
patient. The particulars on the label shall be
indelible, easily legible and clearly
comprehensible to the intended user or patient.
When determining the official language of the
Union in which the information set out in Section
23 of Annex I or other information to be provided
by the manufacturer shall be made available,
Member States shall consider accepting another
official language of the Union in which the
information is made available, taking into
consideration the technical knowledge,
experience, education or training of the average
intended user(s).
Where a device is made available exclusively to
professional users, the information referred to
in Section 23 of Annex I shall be provided by the
manufacturer in English.
Justification
Where a device is made available exclusively to professional users, the information referred to in
Section 23 of Annex I should be provided in English. Providing translations into additional languages
does not lead to an increase in patient safety. Healthcare professionals in the European Union can
reasonably be expected to understand English, as they undergo extensive professional education and
training. English is a commonly understood working language among healthcare professionals across
the EU. An amendment would be also necessary to Recital 15.
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▪ Person responsible for regulatory compliance
Article 15
The European Commission has amended Article 15 by removing the obligation for a person
seeking to become the Person Responsible for Regulatory Compliance (PRRC) to demonstrate
specific formal qualifications. While the deletion of the requirement for a specific diploma,
certificate, or other formal qualification is welcomed, the tasks assigned to the PRRC
nevertheless require that this person possesses appropriate and sufficient professional
experience.
Commission Proposal Article 15
Original Text Proposed Change
1. Manufacturers shall have available within their
organisation at least one person responsible for
regulatory compliance who possesses the
requisite expertise in the field of medical devices.
Without prejudice to national provisions regarding
professional qualifications, manufacturers of
custom-made devices may demonstrate the
requisite expertise referred to in the first
subparagraph by having at least two years of
professional experience within a relevant field of
manufacturing.
[…]
6. Authorised representatives shall have
permanently and continuously at their disposal at
least one person responsible for regulatory
compliance who possesses the requisite
expertise regarding the regulatory requirements
for medical devices in the Union.
1. Manufacturers shall have available within their
organisation at least one person responsible for
regulatory compliance who possesses the
requisite expertise in the field of medical devices.
The requisite expertise shall be demonstrated
by four years of professional experience in
regulatory affairs or in quality management
systems relating to medical devices.
Without prejudice to national provisions regarding
professional qualifications, manufacturers of
custom-made devices may demonstrate the
requisite expertise referred to in the first
subparagraph by having at least two years of
professional experience within a relevant field of
manufacturing.
[…]
6. Authorised representatives shall have
permanently and continuously at their disposal at
least one person responsible for regulatory
compliance who possesses the requisite
expertise regarding the regulatory requirements
for medical devices in the Union. The requisite
expertise shall be demonstrated by four years
of professional experience in regulatory affairs
or in quality management systems relating to
medical devices.
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Justification
The functions assigned to the PRRC require a certain level of qualification. The requirement set out in
the current Article 15(1)(a) for a diploma, certificate or other evidence of formal qualification appears
to be superfluous. Nevertheless, the PRRC must possess a basic understanding of regulatory and
quality management matters, which is indispensable for the proper fulfilment of their responsibilities.
Therefore, the requirement laid down in the current version of Article 15(1)(b) should not be deleted.
The same applies to the current version of Article 15(6)(b).
The removal of the obligation for micro and small enterprises relying on an external PRRC to ensure that
this person is available “permanently and continuously”, replacing it with a general availability
requirement in Article 15(2), is welcomed. This change better reflects the operational realities of these
manufacturers while maintaining an adequate level of regulatory oversight.
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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. This additional requirement is critical and raises significant concerns.
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.
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
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
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
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
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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.
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.
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 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
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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.
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▪ Expert panels
Article 106
Article 106 describes the general principles pertaining to the role and tasks of independent expert
panels. The significantly revised provision by the Commission proposal intends to expand the type
of expertise available in expert panels given the broader range of areas in which expert panels
provide advice and their involvement in the regulatory system.1
Commission Proposal Article 106
Original Text Proposed Change
[…]
4. Expert panels shall take into account relevant
information provided by stakeholders including
patients' organisations and healthcare
professionals’ associations.
[…]
[…]
4. Expert panels shall take into account relevant
information provided by stakeholders including
patients' organisations and, healthcare
professionals’ associations, notified bodies'
organisations and manufacturer’s
associations.
[…]
Justification
To meet the objective of giving impartial and objective opinions, expert panels shall have access to
information provided by all relevant stakeholders, including notified bodies' organisations and
manufacturer’s associations.
1 Cf. recital 45 of the Commission Proposal.
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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.
Commission Proposal Article 106b
Original Text Proposed Change
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:
(a) regulatory status of products and classification
of devices in accordance with Articles 4, 4a, 51,
51a and 51b of this Regulation and Articles 3, 3a,
47, 47a and 47b of Regulation (EU) 2017/746;
(b) derogations from the applicable conformity
assessment procedures in accordance with
Articles 59 and 59a of this Regulation and Articles
54 and 54a of Regulation (EU) 2017/746;
(c) clinical evaluation, clinical investigations,
performance evaluation and performance studies
in accordance with Chapter VI of this Regulation
and Chapter VI of Regulation (EU) 2017/746,
including support to the coordinating Member
State for the coordinated assessment procedure
for clinical investigations and performance
studies referred to in Article 78 of this Regulation
and Article 74 of Regulation (EU) 2017/746;
(d) vigilance and market surveillance in
accordance with Chapter VII of this Regulation
and Chapter VII of Regulation (EU) 2017/746,
including support to the coordinating competent
Deletion of proposed Article 106b.
Given the specific characteristics of the medical
device sector, establishing a separate, truly
impartial, specialised Office for medical devices
may be a more effective long-term solution than
transferring these tasks to the EMA.
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authority for the coordinated procedure referred
to in Article 89(9) of this Regulation and Article
84(9) of Regulation (EU) 2017/746.
2. The EMA shall provide scientific, technical and
administrative support to the Commission for the
establishment of Union regulatory sandboxes in
accordance with Article 59c of this Regulation and
Article 54c of Regulation (EU) 2017/746.
3. The EMA shall set up a support scheme for
manufacturers of medical devices and in vitro
diagnostic medical devices, which are micro,
small and medium-sized within the meaning of
Recommendation 2003/361/EC, regarding the
requirements of this Regulation and Regulation
(EU) 2017/746.
4. The EMA shall have access to Eudamed and any
electronic system referred to in Article 33(2) of
Regulation (EU) 2017/745 or Article 30(2) of
Regulation (EU) 2017/746 that is not included in
Eudamed.
Justification
The EMA’s technical and human resources are of particular concern. The agency currently has only
limited specific expertise in the field of medical devices, especially when compared with its many years
of experience in the regulation of medicinal products. Without a substantial expansion of its technical
expertise, there is a risk that the EMA will formally assume a central role while being unable in practice
to fulfil this role with the necessary depth and quality. This poses a particular risk for substance-based
medical devices, combination products and complex demarcation issues.
Furthermore, the role of the EMA in the decision-making process remains unclear. The agency is
expected to coordinate, support and promote exchange without being granted any decision-making
powers of its own. This intermediate position risks leading to a diffusion of responsibility, as national
authorities may rely on the EMA while it remains unclear who ultimately bears responsibility for
substantive assessments and potential incorrect decisions. Furthermore, there is little reason to
believe that the EMA would refrain from actively influencing decisions regarding the regulatory status
of products.
Access to EUDAMED and other electronic systems also presents a mixed picture. While it allows for
improved coordination and analysis of vigilance and market surveillance data, it simultaneously raises
questions regarding data sovereignty, the allocation of responsibilities and practical integration into
existing national workflows.
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▪ Annex I – Requirements regarding the information supplied with the device
Chapter III 23.1
The European Commission has amended the provisions on instructions for use supplied in a
non-paper format by referring to the Commission Implementing Regulation (EU) 2021/2226
allowing manufacturers of medical devices intended for professional users to provide instructions
for use in electronic format. While this adaptation is welcomed, it remains necessary to extend
this possibility to all medical devices, irrespective of the intended user.
Commission Proposal Annex I Chapter III 23.1(f)
Original Text Proposed Change
23.1. General requirements regarding the
information supplied by the manufacturer
[…]
(f) Instructions for use may be provided to the user
in non-paper format (e.g. electronic) to the extent,
and only under the conditions, set out in
Commission Implementing Regulation (EU)
2021/2226 or in any subsequent implementing
rules adopted pursuant to this Regulation.
23.1. General requirements regarding the
information supplied by the manufacturer
[…]
(f) Instructions for use may be provided to the user
in non-paper format (e.g. electronic) to the extent,
and only under the conditions, set out in
Commission Implementing Regulation (EU)
2021/2226 or in any subsequent implementing
rules adopted pursuant to this Regulation. Users
shall have the possibility to obtain instructions
for use in paper format upon request.
Justification
Implementing Regulation (EU) 2021/2226 has been overtaken by technological developments. The
risks it seeks to address with regard to internet availability for professional and lay users no longer
reflect the current state of the art. These assumptions have remained largely unchanged since
Regulation (EU) No 207/2012, despite the significant progress in the availability, reliability and
robustness of internet connections over the past decade.
Providing instructions for use in electronic form offers several significant advantages. First, it reduces
environmental impact by cutting down on paper consumption. Second, it lowers costs for the medical
device industry by eliminating printing and distribution expenses. A further benefit is increased
flexibility: electronic IFUs can be updated easily, ensuring that users always have access to the most
current information. This not only maintains but can even enhance the level of safety.
Practical experience from other jurisdictions that allow electronic instructions for use (eIFU) confirms
this assessment. For example, the United States of America permits the provision of eIFU for all
medical devices, irrespective of whether they are intended for professional or lay use.
The option to provide instructions for use in electronic form should therefore be available for all
medical devices and accessories. At the same time, users should always retain the right to obtain the
instructions for use in paper form upon request.
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▪ Annex VI – Information to be submitted upon the registration of devices and economic
operators in accordance with articles 29(4) and 31, core data elements to be provided to
the UDI database together with the UDI-DI in accordance with articles 28 and 29, and the
UDI system
Part B Core data elements to be provided to the UDI database in accordance with articles 28 and
29
The European Commission has proposed to expand the list of core data elements to be submitted
to the UDI database under Articles 28 and 29 by adding information on the Member States in
which a device is, or is intended to be, made available.
Commission Proposal Annex VI Part B 4.
Original Text Proposed Change
The manufacturer shall provide to the UDI
database the following information relating to the
manufacturer and the device:
[…] 4. Member States where the device is or is to
be made available,
[…]
The manufacturer shall provide to the UDI
database the following information relating to the
manufacturer and the device:
[…] 4. Member States where the device is or is to
be made available,
[…]
Justification
The further expansion of the scope of core data elements to be provided to the UDI database beyond
the existing requirements is inappropriate. In the event of a serious incident, the competent authorities
of the affected Member States are already duly informed through established vigilance mechanisms.
Against this background, the mere provision of distribution-related information does not provide any
tangible additional regulatory value and therefore cannot justify the significant additional
administrative burden imposed on manufacturers.
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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.
Commission Proposal Rule 6
Original Text Proposed Change
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 application, in which case
they are classified as class IIb.
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 application, in which case
they are classified as class IIb.
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Commission Proposal Rule 7
Original Text Proposed Change
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
- 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;
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
- 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 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.
Commission Proposal Rule 11
Original Text Proposed Change
Software which is intended to generate an output
that confers a clinical benefit and is used in a non-
serious situation 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:
- 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;
- 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;
- 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;
Software which is intended to generate an output
that confers a clinical benefit and is used in a non-
serious situation 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:
- 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;
- 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;
- 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;
Justification
The Commission’s proposal to introduce a default class I classification under the revised Rule 11 is
welcomed, as it aims to introduce greater proportionality for clinical benefit software.
However, a fundamental inconsistency remains within Rule 11. While the opening part of the rule
allows for a class I classification, the final indent effectively makes it almost impossible for software to
be classified as class I in practice.
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In particular, the final indent referring to software intended “to inform clinical management in a critical
or serious situation” renders the identification of class I software ineffective. In practice, virtually all
software outputs relate to situations beyond “non-serious”, thereby triggering a default classification
as class IIa.
Illustrative examples include:
– BMI calculators used for obesity risk screening → Class IIa
– Dyscalculia exercise applications → Class IIa
This approach results in trivial, low-risk software tools being placed in the same risk class as genuinely
medium- or high-risk software, such as ECG analysis software. Consequently, such products would be
subject to full conformity assessment procedures involving a notified body, leading to disproportionate
time and cost burdens. Low-risk and non-critical products should be made available to patients and
users without unnecessary regulatory obstacles.
Moreover, the proposal would create international regulatory divergence:
– FDA: Simple clinical calculators and certain clinical decision support tools are excluded from active
regulation, whereas they would fall under Class IIa in the EU.
– UK MHRA: Simple clinical calculators are excluded from medical device classification, while they
would be Class IIa under the proposed EU approach.
As a result, the proposed revision of Rule 11 for software fails to achieve its stated objective of
simplification and risks discouraging digital health innovation within the EU market.
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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.
Commission Proposal Rule 14
Original Text Proposed Change
All devices incorporating, as an integral part, a
substance which, if used separately, can be
considered to be a medicinal product, as defined
in point 2 of Article 1 of Directive 2001/83/EC,
including a medicinal product derived from
human blood or human plasma, as defined in
point 10 of Article 1 of that Directive, and that has
an action ancillary to that of the devices, are
classified as class III.
All devices incorporating, as an integral part, a
substance which, if used separately, can be
considered to be a medicinal product, as defined
in point 2 of Article 1 of Directive 2001/83/EC,
including a medicinal product derived from
human blood or human plasma, as defined in
point 10 of Article 1 of that Directive, and that has
an a clinically relevant ancillary to that of the
devices action in order to achieve the intended
medical purpose, are classified as class III.
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.
Commission Proposal Rule 21
Original Text Proposed Change
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:
− class III if they, or their products of
metabolism, are systemically absorbed by
the human body in order to achieve the
intended purpose;
− class III if they achieve their intended
purpose in the stomach or lower
gastrointestinal tract and they, or their
products of metabolism, are systemically
absorbed by the human body;
− class IIa if they are applied to the skin or if
they are applied in the nasal or oral cavity
as far as the pharynx, and achieve their
intended purpose on those cavities; and
− class IIb in all other cases.
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:
− class III if they, or their products of
metabolism, are systemically absorbed by
the human body in order to achieve the
intended purpose;
− class III if they achieve their intended
purpose in the stomach or lower
gastrointestinal tract and they, or their
products of metabolism, are systemically
absorbed by the human body;
− class IIa if they are applied to the skin or if
they are applied in the nasal or oral cavity
as far as the pharynx, and achieve their
intended purpose on those cavities; and
− class IIb in all other cases.
Justification
The proposed change 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. In particular, 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
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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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