The European Association of
Medical devices Notified Bodies
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Editor : Team-NB Adoption date 16/06/2026 Version 1
Micro and Small Enterprise Considerations.
Introduction
Micro and small medical device and in vitro diagnostic manufacturers form a critical component of the
European medical technology ecosystem. The Commission’s own estimate, page 1 of COM (2025) 1023
proposal, indicates that approximately 90% of manufacturers are SME’s, the majority of which are
micro and small enterprises. They are an important source of innovation, niche clinical solutions, and
patient access to specialised technologies. Many of these manufacturers operate with limited product
portfolios, often a single product line, and are highly dependent on predictable and timely market
access under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
frameworks for their commercial viability and survival.
The ongoing revision of the European medical device regulatory framework reflects a shared policy
objective: to improve system efficiency, increase predictability, and better support smaller
manufacturers. Among the proposed measures is an expectation that notified bodies offer significantly
reduced conformity assessment fees, up to a 50% discount for micro and small enterprises.
This proposal risks unintended consequences. It does not sufficiently account for the practical realities
of conformity assessment activities, the actual resource burden involved in assessing less mature
regulatory systems, nor the financial constraints under which notified bodies themselves operate. A
sustainable regulatory ecosystem requires that support measures for small manufacturers are
carefully designed so that they address root causes of regulatory difficulty without transferring
disproportionate operational and financial risk to notified bodies, whose designation, competence,
and independence are fundamental to patient safety and system credibility.
Problem Statement
The proposal for mandatory or expected fee discounts by notified bodies for micro and small medical
device manufacturers (page 56, amendment to article 50. The proposal is 50% reduction for micro,
25% reduction for small and a deferment of fees until after conformity assessment is completed) raises
substantial concerns regarding fairness, feasibility, and system sustainability.
Evidence from conformity assessment practice consistently shows that micro and small manufacturers
often require significantly greater regulatory support and assessment effort than larger, more
established organisations. This is typically reflected in:
• Higher volumes of clarification questions and follow-up interactions during technical
documentation assessment,
• Increased numbers and complexity of non-conformities identified,
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• Repeated cycles of resubmission due to immature or incomplete quality management systems
and technical files.
These challenges are frequently attributable not to a lack of commitment by small manufacturers, but
to structural limitations and lacking experience. Many micro and small enterprises have limited
embedded regulatory affairs expertise. This situation is likely to be further exacerbated by the
proposed removal of the requirement in Article 15 for micro and small enterprises to have a PRRC
within the organisation, thereby reducing a critical mechanism intended to ensure regulatory
competence at source.
In addition, clinical investigation planning and execution represent one of the most resource-intensive
aspects of the conformity assessment process, both in terms of time and financial investment. For
micro and small manufacturers in particular, the associated costs are sometimes unachievable, placing
a disproportionate burden on organisations with limited financial and operational capacity. These costs
are further compounded by the extended duration over which clinical investigations are conducted, as
well as the specialised personnel and infrastructure required to design, manage, monitor, and analyse
such studies.
This challenge is exacerbated by a lack of early regulatory clarity. In many cases, micro and small
manufacturers must commit significant resources to clinical evidence generation without sufficient
certainty that the chosen study design or evidence strategy will ultimately meet the General Safety
and Performance Requirements set out in Annex I of the Medical Device Regulation. This uncertainty
is often linked to limited in-house regulatory expertise, making it difficult for smaller organisations to
confidently align their clinical strategies with regulatory expectations from the outset.
As a result, there is a substantial risk that costly and time-consuming clinical investigations may need
to be repeated, adapted, or supplemented, further increasing the financial and operational strain.
Addressing this issue is therefore critical, not only to alleviate the burden on smaller manufacturers,
but also to improve the overall efficiency, predictability, and accessibility of the regulatory system.
At the same time, notified bodies operate under highly constrained economic and regulatory
conditions. They face increasing designation and oversight requirements, rising liability exposure, and
obligations to recruit and retain scarce technical and clinical experts. The cost of conformity
assessment is fundamentally driven by expert time and procedural rigor, not the size of the economic
operator. Imposing substantial fee reductions in cases where assessment effort is demonstrably higher
risks undermining notified body capacity, incentivising risk, avoidant behaviour, or unintentionally
reducing access to assessment service, contrary to the goals of the MDR and IVDR.
For many micro and small manufacturers, operating with a single product or a very limited portfolio is
common. This model inherently increases financial vulnerability, as revenue is dependent on one
primary source. Within this context, the requirements set out in MDCG 2019-6 impose a
disproportionately high administrative and financial burden on them.
In particular, the expectation that notified bodies conduct annual sampling and repeated reviews of a
device that has already undergone thorough assessment at the point of certification creates a recurring
strain. This includes revisiting technical documentation even where only minimal updates, such as
routine post-market surveillance data, are available. In practice, this level of repeated scrutiny often
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provides limited additional value and results in an excessive regulatory burden for both manufacturers
and notified bodies.This approach is also inconsistent when compared to the treatment of higher-risk
devices covered under product certificates, where the depth and frequency of technical
documentation reassessment may be less intensive following initial certification. As a result,
manufacturers with a single device may be subject to more frequent and repetitive technical review
than those managing multiple or higher-risk devices, despite the latter being inherently more complex.
The cumulative effect is a misalignment between policy intent and operational reality. Measures
intended to support micro and small manufacturers risk destabilising notified bodies, increasing
bottlenecks, and ultimately impairing market access for the very entities they aim to help.
A more sustainable approach is required, one that targets structural capability gaps, improves
regulatory quality at source, fosters innovation, and enhances system efficiency without eroding the
independence or financial viability of notified bodies.
It is also important to recognise, that consistency of approach across the system is critical to
maintaining both regulatory integrity and a level playing field. Where individual notified bodies adopt
divergent practices, particularly in relation to fee structures or perceived concessions, these
approaches are quickly extrapolated by stakeholders and may create further issues across the wider
system.
In this context, the principle of “same service, same cost” reflects not only economic reality but also
the need to preserve fairness, independence, and confidence in conformity assessment activities. Any
deviation from this principle risks introducing competitive distortion, undermining the collective
position of notified bodies, and ultimately weakening the consistency that the European Commission
itself expects under a harmonised regulatory framework. This further reinforces the need for solutions
that are systemic, policy-driven, and implemented at EU or Member State level, rather than through
ad hoc operational measures at individual notified body level.
Pragmatic Alternative Solutions to Support Micro and Small Manufacturers.
1. Formalise structured dialogue throughout the conformity assessment process and beyond
Structured dialogue is explicitly highlighted in the proposed MDR/IVDR reforms as a mechanism to
improve predictability, proportionality, and mutual understanding in notified body engagement with
micro and small manufacturers.
To further enhance these objectives, it is proposed that a structured dialogue opportunity be
systematically offered to micro and small manufacturers each time a formal round of questions is
issued during conformity assessment, at no additional cost. This dialogue, without constituting
consultancy and with the clear option for the manufacturer to decline, would allow both parties to
align on the intent, scope, and regulatory basis of the questions raised during the assessment, so the
expectations of the notified body are clear from the start.
In practice, this would support early clarification of clinical, performance, and QMS expectations;
reduce the risk of misinterpretation and iterative question cycles; and enable more efficient planning
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of limited regulatory, financial, and personnel resources by small manufacturers. By ensuring that
responses directly address notified body concerns at first submission, this approach has the potential
to improve assessment efficiency, reduce avoidable delays, and enhance overall system effectiveness
without compromising notified body independence or regulatory rigor.
From the perspective of micro and small manufacturers, the introduction of a mechanism comparable
to the FDA’s Q-Submission programme could deliver substantial benefits. These organisations often
operate with limited regulatory experience and constrained resources, making early clarity on
regulatory expectations particularly critical.
While due regard must be given to the provisions of Section 1.2. 3, of the Medical Device Regulation,
specifically to safeguard the impartiality of notified bodies, it should nevertheless be possible to
establish a structured, non-binding pre-submission process. Within such a framework, manufacturers
could present proposed protocols, study designs, or testing strategies in advance of execution and
receive high-level feedback from the notified body on their suitability to demonstrate conformity with
relevant requirements.
Importantly, any feedback provided would not prejudice the notified body’s independence, nor
constitute a commitment to accept the final results. However, even non-binding input from a decision-
making body would introduce a meaningful degree of clarity and predictability into the conformity
assessment process.
For micro and smaller manufacturers in particular, this increased predictability would significantly
reduce the risk of investing limited financial and operational resources in inadequate or misaligned
evidence-generation activities. Ultimately, such an approach would support more efficient
development pathways, improve the quality of submissions, and enhance overall access to the
regulatory system for organisations with less established regulatory expertise.
2. Surveillance Requirements
A more proportionate and risk-based approach to post-certification sampling is essential, particularly
for micro and small manufacturers of Class IIa and IIb non-implantable devices who have single product
certificates. As currently reflected in MDCG 2019-6, notified bodies are expected to carry out regular
and structured surveillance activities, including technical documentation sampling, as part of the
certification lifecycle. However, in practice, this can lead to repetitive reassessment of devices that
have already undergone a comprehensive and robust evaluation at the point of initial certification.
Regulatory oversight should instead focus on areas of genuine risk, such as significant design changes,
emerging safety signals, or substantive updates to clinical or technical documentation that could
impact the safety and performance of the device. Where a device has been thoroughly assessed and
no meaningful changes or concerns have arisen, it should be possible for the notified body to justify a
more targeted approach to subsequent sampling activities.
Introducing greater flexibility within the current framework would allow notified bodies to apply
justified, risk-based discretion, avoiding unnecessary repetition of full technical documentation
reviews on an annual basis. This would not only reduce administrative burden, but also better align
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with the core principles of the Medical Device Regulation, which emphasise proportionality and risk-
based decision-making.
Importantly, addressing this issue would correct an unintended imbalance in the current system,
whereby micro and small manufacturers with single-device portfolios may be subject to more frequent
and intensive scrutiny than manufacturers of higher-risk devices managed under product certification
approaches. A revised, more targeted sampling methodology would ensure that regulatory effort is
directed where it delivers the greatest value, rather than being expended on low-risk, duplicative
activities. This would significantly improve efficiency across the conformity assessment system while
maintaining high standards of safety and performance.
3. EU, Level Regulatory Capability Support Programmes
There is a clear need to establish EU or Member State, funded initiatives focused on strengthening
regulatory capability among micro and small medical device manufacturers, particularly at the early
stages of their MDR and IVDR onboarding.
In practice, manufacturers of this size often engage with the conformity assessment process too late
in their development journey, which frequently results in significant challenges in generating adequate
technical documentation and clinical evidence once regulatory review has commenced.
A more structured and proactive education framework could address this gap through initiatives such
as formal MDR/IVDR onboarding programmes, non, binding and non, assessment, based pre,
submission technical documentation readiness reviews, and standardised guidance addressing
common non, conformities observed across assessments.
Supporting resources could include a series of structured webinars and educational materials that can
be replayed on demand, enabling manufacturers to better understand regulatory expectations and
allowing notified bodies to consistently direct stakeholders to authoritative reference materials when
questions arise.
Such a programme would also support greater alignment of expectations between notified bodies,
competent authorities, manufacturers, consultants, and other stakeholders, thereby improving overall
submission quality and reducing avoidable assessment iterations. While the development of a
coordinated education framework of this nature represents a significant undertaking and would
require dedicated EU, level funding, (potentially through mechanisms such as Horizon Europe,
NoBoCAP, or similar initiatives) notified bodies remain open to supporting and contributing their
technical expertise to the development of content, recognising the long-term benefits this would bring
to the efficiency, consistency, and sustainability of the regulatory system as a whole.
It is important to recognise that the challenges faced by micro and small manufacturers extend beyond
notified body fees alone and are rooted in a wider, interconnected regulatory ecosystem. While
reductions in notified body fees may provide some limited relief, such measures in isolation are
insufficient to address the structural cost burdens associated with conformity assessment.
In particular, the provision of dedicated, non-repayable funding mechanisms at both EU and national
levels are more meaningful to micro and small manufacturers. These funding programmes should
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explicitly cover not only regulatory activities, but also the substantial costs associated with laboratory
testing, clinical investigation, and contracted research organisations (CROs), which collectively
represent a significant proportion of the overall financial burden for micro and small manufacturers.
Strengthening and expanding such funding instruments across Member States is therefore essential to
achieving a more equitable and accessible regulatory environment.
Furthermore, it should be emphasised that reductions in notified body fees alone cannot constitute a
comprehensive solution. Notified bodies, the majority of which operate as private entities, must retain
the autonomy to determine whether and to what extent fee reductions can be applied, based on the
sustainability of their own operational and capital expenditure structures. As a result, any discounts
offered will necessarily vary between notified bodies and cannot be uniformly mandated at EU level
without risking impacts on capacity, quality, or independence.
Equally, it is critical that other key actors within the conformity assessment ecosystem, including
laboratories, CROs, and regulatory consultants are encouraged to adopt a similar approach. A
coordinated effort across all stakeholders is required to ensure that cost reductions are meaningful,
balanced, and sustainable. Without such a holistic approach, the cumulative financial barriers will
remain disproportionately high for micro and small manufacturers, limiting their ability to successfully
navigate the regulatory framework.
4. MDR/IVDR Consultants
Many micro and small medical device manufacturers rely heavily on external regulatory consultants to
navigate the complexities of the MDR/IVDR. However, these consultants are frequently selected based
on cost rather than demonstrated competence or relevant regulatory experience. This creates a
significant vulnerability within the system, as manufacturers, particularly those with limited in-house
regulatory expertise, are often not in a position to effectively assess or verify the quality and suitability
of the advice being provided.
As a result, there is a tangible risk that manufacturers receive guidance that is incomplete,
misinterpreted, or misaligned with regulatory expectations and notified body practices. This can lead
to poor-quality submissions, prolonged review timelines, avoidable non-conformities, and ultimately
increased costs and delays.
While highly experienced consultants, particularly those with prior notified body or equivalent
regulatory assessment experience, can provide robust and well-aligned guidance, such expertise is not
consistently accessible, nor easily identifiable by less experienced organisations.
This situation highlights a broader structural gap within the regulatory ecosystem. Unlike notified
bodies, which are subject to stringent requirements for competence, qualification, and ongoing
oversight, there are currently no equivalent, transparent mechanisms to ensure or demonstrate the
competency of regulatory consultants. For micro and small manufacturers, this creates a challenging
environment in which critical decisions rely on advice that may vary significantly in quality.
To address this, it would be beneficial to introduce mechanisms that provide an additional layer of
assurance for manufacturers without compromising the independence of notified bodies. Structured
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dialogue could be leveraged to allow notified bodies to review, at a high level, the adequacy and
correctness of approaches or interpretations proposed by consultants. Such interactions would remain
non-binding and focused on “what” is required rather than “how” to comply, thereby maintaining
impartiality while offering valuable validation to manufacturers.
This approach would provide micro and small enterprises with greater confidence that the advice they
are relying on is aligned with regulatory expectations, reducing the risk of costly missteps. This could
significantly improve the consistency and quality of regulatory submissions at source, strengthen trust
across the system, and deliver meaningful benefits for micro and small manufacturers.
5. Offer remote or hybrid audit options where appropriate
The broader and more systematic introduction of remote and hybrid audit models would deliver
significant benefits for micro and small medical device manufacturers, particularly those with limited
resources and have small or remote operational teams.
On-site audits often require substantial preparation, dedicated staff availability, and logistical
coordination, which can place a disproportionate burden on smaller enterprises that may lack spare
regulatory or quality personnel.
A risk-based and proportionate approach to remote or hybrid audits, considering factors such as device
technology, long, standing market history, organisational maturity, and demonstrated regulatory
compliance, would allow oversight activities to be tailored appropriately without compromising
regulatory rigor.
Manufacturers with stable product portfolios, consistent quality management system performance, a
strong compliance record, and no history of serious non, conformities, field safety corrective actions,
or unresolved post, market concerns could be well suited to partially or fully remote audits. Such an
approach would reduce travel and administrative costs, allow for more flexible scheduling, and better
accommodate organisations with limited on, site staff or distributed teams. By aligning audit modality
with actual risk and performance history, remote and hybrid audits can meaningfully reduce financial
and administrative burdens for smaller manufacturers while preserving effective regulatory oversight,
supporting predictability, and improving overall system efficiency.
6. Guidance and Template Harmonisation
A coherent and predictable regulatory system requires not only high, quality guidance, but also a clear
and consistent pathway for how such guidance is applied in practice across different device types and
regulatory stages.
The Medical Device Coordination Group (MDCG) has published an extensive and growing body of
guidance intended to harmonise MDR and IVDR implementation, covering areas such as classification,
borderline determinations, clinical evaluation, performance studies, and post, market requirements.
However, without structured support, micro and small manufacturers in particular often struggle to
identify which guidance is most relevant to their specific device or how multiple documents should be
applied in combination, leading to misclassification, incomplete evidence packages, and avoidable
assessment delays.
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Actively guiding manufacturers in the appropriate and proportionate use of MDCG guidance, for
example by mapping key documents to assessment stages and device categories, would significantly
reduce regulatory uncertainty and align submissions with EU expectations from the outset. In parallel,
closer collaboration between regulators, notified bodies, and industry stakeholders to develop
harmonised technical documentation templates, anonymised examples of high, quality submissions,
and clearer interpretations of commonly misunderstood requirements would further strengthen
consistency and efficiency. Embedding these elements within a unified, formalised, and ideally
digitised submission framework would represent a major step forward for the system as a whole,
driving harmonisation, improving first, pass success rates, and reducing administrative burden for
manufacturers of all sizes.
Importantly, while such measures would be particularly beneficial for micro and small enterprises with
limited regulatory capacity, the advantages of clarity, consistency, and predictability would extend
equally to larger manufacturers, notified bodies, and competent authorities, making this a
foundational enabler of a more effective and resilient EU regulatory ecosystem.
Conclusion
Notified bodies fully support the objective of strengthening the position of micro and small
manufacturers within the European regulatory framework and ensuring continued patient access to
safe and effective medical technologies. However, the challenges faced by these organisations are
structural and systemic in nature, extending far beyond notified body fees alone. Measures focused
solely on fee reductions risk addressing symptoms rather than root causes, and may unintentionally
undermine the capacity, independence, and sustainability of the conformity assessment system.
The analysis presented in this paper demonstrates that the primary barriers encountered by micro and
small manufacturers relate to limited regulatory experience, high costs associated with clinical
evidence generation and external services, variability in the quality of regulatory advice, and
inefficiencies arising from disproportionate or repetitive conformity assessment activities.
Addressing these challenges requires a more balanced and ecosystem-wide approach. The most
effective solutions lie in improving regulatory capability at source, increasing predictability of
requirements, and ensuring that oversight activities are applied in a proportionate and risk-based
manner. In this context, the measures proposed in this paper provide a targeted and practical path
forward, including:
• Strengthening and formalising structured dialogue, including pre-submission interactions, to
improve early alignment and reduce uncertainty;
• Introducing greater flexibility in post-certification surveillance and sampling, enabling notified
bodies to apply justified, risk-based approaches and avoid unnecessary duplication;
• Establishing EU and Member State-funded programmes to support regulatory capability
development and to offset the broader costs of clinical investigations, laboratory testing, and
associated services;
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• Improving transparency, consistency, and assurance in the use of regulatory consultants,
including mechanisms for validation of regulatory approaches through structured dialogue;
• Expanding the use of remote and hybrid audit models where appropriate, reducing operational
burden on smaller organisations;
• Advancing harmonisation of guidance, templates, and submission frameworks to improve
clarity, consistency, and first-time quality of submissions.
Collectively, these measures address the underlying drivers of inefficiency and cost, while preserving
the integrity, independence, and technical rigour of notified bodies. Importantly, they support a more
equitable and accessible regulatory environment without introducing distortions or unintended
consequences associated with mandatory fee reductions.
A sustainable and resilient regulatory system must be built on proportionality, predictability, and
shared responsibility across all actors in the ecosystem. By focusing on these principles, the European
framework can more effectively support innovation from micro and small manufacturers, while
continuing to uphold the highest standards of patient safety and public health.
18.06.2026
Datei
PD
Medical Devices
Medical Device Coordination Group Document MDCG 2021-5 Rev. 1 - Appendix
Page 1 of 6
MDCG 2021-5 Rev. 1
Guidance on standardisation for medical devices
Appendix: Transition to the ‘EU REP’ symbol in
EN ISO 15223-1
June 2026
This document has been endorsed by the Medical Device Coordination Group
(MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is
composed of representatives of all Member States and it is chaired by a representative
of the European Commission.
The document is not a European Commission document and it cannot be regarded as
reflecting the official position of the European Commission. Any views expressed in
this document are not legally binding and only the Court of Justice of the European
Union can give binding interpretations of Union law.
Medical Devices
Medical Device Coordination Group Document MDCG 2021-5 Rev. 1 - Appendix
Page 2 of 6
Background
Regulation (EU) 2017/745 on medical devices1 (MDR) and Regulation (EU) 2017/746 on
in vitro diagnostic medical devices2 (IVDR) prescribe that “Where appropriate, the
information supplied by the manufacturer shall take the form of internationally recognised
symbols, taking into account the intended users. Any symbol or identification colour used shall
conform to the harmonised standards or CS [common specifications]. In areas for which no
harmonised standards or CS exist, the symbols and colours shall be described in the
documentation supplied with the device” (Section 23.1(h) of Annex I MDR; Section 20.1(h)
of Annex I IVDR).
Accordingly, harmonised European standards, the references of which are published in the
Official Journal of the European Union (OJEU), that contain indications on symbols and
identification colours intended to be used by manufacturers of devices to supply the
information required by the MDR or IVDR can be regarded as “compulsory standards”, as an
exception from the general rule of voluntary use of standards established by Article 2(1) of
Regulation (EU) No 1025/2012 on European standardisation3.
This is the case of the harmonised standard EN ISO 15223-1:2021 Medical devices - Symbols
to be used with information to be supplied by the manufacturer - Part 1: General
requirements (ISO 15223-1:2021)4, the reference of which is published in the OJEU since
January 2022 to confer a presumption of conformity in support of the MDR5 and the IVDR6.
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1, ELI:
http://data.europa.eu/eli/reg/2017/745/oj).
2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L
117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/2017/746/oj).
3 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC,
94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the
European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No
1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12, ELI:
http://data.europa.eu/eli/reg/2012/1025/oj).
4
https://standards.cencenelec.eu/ords/f?p=CEN:110:::::FSP_PROJECT,FSP_ORG_ID:68559,581003&cs=19
D620A9FF93853AD8A64862A3A63D1B4.
5 Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU)
2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of
health care products, aseptic processing of health care products, quality management systems, symbols to be
used with information to be supplied by the manufacturer, processing of health care products and home light
therapy equipment (OJ L 1, 5.1.2022, p. 11, ELI: http://data.europa.eu/eli/dec_impl/2022/6/oj).
6 Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision
(EU) 2021/1195 as regards harmonised standards for sterilisation of health care products, aseptic processing
of health care products, quality management systems, symbols to be used with information to be supplied by
http://data.europa.eu/eli/reg/2017/745/oj
http://data.europa.eu/eli/reg/2017/746/oj
http://data.europa.eu/eli/reg/2012/1025/oj
https://standards.cencenelec.eu/ords/f?p=CEN:110:::::FSP_PROJECT,FSP_ORG_ID:68559,581003&cs=19D620A9FF93853AD8A64862A3A63D1B4
https://standards.cencenelec.eu/ords/f?p=CEN:110:::::FSP_PROJECT,FSP_ORG_ID:68559,581003&cs=19D620A9FF93853AD8A64862A3A63D1B4
http://data.europa.eu/eli/dec_impl/2022/6/oj
Medical Devices
Medical Device Coordination Group Document MDCG 2021-5 Rev. 1 - Appendix
Page 3 of 6
The symbol for authorised representatives: from ‘EC REP’ to ‘EU REP’
According to Articles 2(32) MDR and 2(25) IVDR, “‘authorised representative’ means any
natural or legal person established within the Union who has received and accepted a written
mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf
in relation to specified tasks with regard to the latter’s obligations under this Regulation”, and
according to Articles 11(1) MDR and IVDR, “Where the manufacturer of a device is not
established in a Member State, the device may only be placed on the Union market if the
manufacturer designates a sole authorised representative”.
The harmonised standard EN ISO 15223-1:2021, in its clause 5.1.2, presents the symbol ‘EC
REP’ for “Authorized representative in the European Community/European Union”. The
references ‘EC’ for “European Community” and ‘European Community’ itself no longer
correspond to the reality of the European Union that replaced and succeeded the European
Community as per the Treaty of Lisbon signed on 13 December 2007 and entered into force
on 1 December 20097.
Therefore, as part of Amendment 28 to the Commission’s standardisation request in support of
the MDR and IVDR (M/575)9, in May 2024 the Commission requested CEN and CENELEC
to revise EN ISO 15223-1 to “include a specific symbol for the authorised representative in the
Union, as ‘EU REP’ instead of ‘EC REP’, removing any reference to the term ‘European
Community’” (Annex III, Part B, point 2.2).
CEN and CENELEC accepted the request in June 2024 and worked with ISO to draft a specific
amendment, adopted by ISO in March 2025 and made available by CEN and CENELEC in
November 2025 as EN ISO 15223-1:2021/A1:2025 Medical devices - Symbols to be used
with information to be supplied by the manufacturer - Part 1: General requirements -
Amendment 1: Addition of defined term for authorized representative and modified EC REP
symbol to not be country or region specific (ISO 15223-1:2021/Amd 1:2025)10.
The amendment adds a definition of “authorized representative” generally referred to “a
country or jurisdiction” (3.20) and introduces in clause 5.1.2 the generic symbol ‘XX REP’ for
the “authorized representative in the identified country or jurisdiction”, where the ‘XX’ text is
the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators,
trueness control materials and human samples (OJ L 4, 7.1.2022, p. 16, ELI:
http://data.europa.eu/eli/dec_impl/2022/15/oj).
7 See https://eur-lex.europa.eu/EN/legal-content/summary/the-treaty-of-lisbon.html.
8 See C(2024)3371 – Standardisation request M/575 Amd 2 https://ec.europa.eu/growth/tools-
databases/enorm/mandate/575Amd2_en.
9 See C(2021)2406 – Standardisation request M/575 https://ec.europa.eu/growth/tools-
databases/enorm/mandate/575_en.
10
https://standards.cencenelec.eu/ords/f?p=CEN:110:::::FSP_PROJECT,FSP_ORG_ID:77231,581003&c
s=171F4D5F8B84F0D6BC09C4C269D86E5B4.
http://data.europa.eu/eli/dec_impl/2022/15/oj
https://eur-lex.europa.eu/EN/legal-content/summary/the-treaty-of-lisbon.html
https://ec.europa.eu/growth/tools-databases/enorm/mandate/575Amd2_en
https://ec.europa.eu/growth/tools-databases/enorm/mandate/575Amd2_en
https://ec.europa.eu/growth/tools-databases/enorm/mandate/575_en
https://ec.europa.eu/growth/tools-databases/enorm/mandate/575_en
https://standards.cencenelec.eu/ords/f?p=CEN:110:::::FSP_PROJECT,FSP_ORG_ID:77231,581003&cs=171F4D5F8B84F0D6BC09C4C269D86E5B4
https://standards.cencenelec.eu/ords/f?p=CEN:110:::::FSP_PROJECT,FSP_ORG_ID:77231,581003&cs=171F4D5F8B84F0D6BC09C4C269D86E5B4
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Medical Device Coordination Group Document MDCG 2021-5 Rev. 1 - Appendix
Page 4 of 6
intended to be “replaced by either the two-letter country code or the three-letter country code
defined in ISO 3166-1 or other text required by the authority having jurisdiction”. Among the
“examples of use for an authorized representative in different countries or jurisdictions”, the
symbol ‘EU REP’ is indicated for the authorised representative in the European Union.
Consequently, according to the harmonised standard EN ISO 15223-1:2021 as amended by EN
ISO 15223-1:2021/A1:2025, to indicate the authorised representative established within
the Union required by the MDR and IVDR for a manufacturer located outside the Union,
in the generic symbol ‘XX REP’ the ‘XX’ text must be replaced by ‘EU’, to get the EU
specific symbol to use, ‘EU REP’.
It is important to clarify that, as such, the change in the symbol for the authorised
representative in the Union, from ‘EC REP’ to ‘EU REP’, is purely editorial in nature. It
reflects a terminology update only and has no impact on the health, safety and
performance characteristics of the device, nor on the role and responsibilities, location or
legal obligations of the authorised representative.
In this sense, the manufacturer of the device does not need a prior approval from a notified
body (if its involvement is required) for a labelling change.
Citation in the OJEU of EN ISO 15223-1:2021/A1:2025 and transition period
The amendment EN ISO 15223-1:2021/A1:2025 was offered by CEN-CENELEC to the
Commission in February 2026 for publication of its reference in the OJEU, in view to have the
harmonised standard EN ISO 15223-1:2021 with its amendment EN ISO 15223-
1:2021/A1:2025 suitable to confer a presumption of conformity to be used by manufacturers
of medical devices and in vitro diagnostic medical devices to comply with the requirements of
the MDR and IVDR on the information to be provided with the device.
The publications took place on 17 June 2026 for the MDR11 and for the IVDR12, with the
addition of a new entry (harmonised standard with its amendment):
EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be supplied by the
manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN ISO 15223-1:2021/A1:2025
11 Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision
(EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be
used with information to be supplied by the manufacturer, medical electrical equipment, transfusion
equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics
and sharps injury protection (OJ L, 2026/1231, 17.6.2026, ELI:
http://data.europa.eu/eli/dec_impl/2026/1231/oj).
12 Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision
(EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied
by the manufacturer (OJ L, 2026/1313, 17.6.2026, ELI: http://data.europa.eu/eli/dec_impl/2026/1313/oj).
http://data.europa.eu/eli/dec_impl/2026/1231/oj
http://data.europa.eu/eli/dec_impl/2026/1313/oj
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Page 5 of 6
intended to replace the previous entry (harmonised standard without the amendment):
EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be supplied by the
manufacturer - Part 1: General requirements (ISO 15223-1:2021)
in sequential order of the respective Commission Implementing Decisions (EU) 2021/118213
and (EU) 2021/119514 as amended.
According to the applicable rules and formats for the publication in the OJEU of references of
harmonised European standards, the reference of the harmonised standard EN ISO 15223-
1:2021 must be deleted, as it has been amended, and replaced by the reference of the
harmonised standard EN ISO 15223-1:2021 with its amendment EN ISO 15223-
1:2021/A1:2025. However, on the basis of information provided by ISO, CEN and CENELEC,
and by Members (competent authorities of the Member States) and Observers (sectorial
stakeholders) of the Subgroup on Standards (WG 2) of the Medical Device Coordination Group
(MDCG)15 about the significant impact of those modifications in time and resources on
manufacturers and other economic operators, the Commission considered necessary and
appropriate to give the concerned interested parties sufficient time to adapt their processes and
devices, for a proportionate and resource efficient transition, by deferring the withdrawal of the
reference of the harmonised standard EN ISO 15223-1:2021 by 60 months from the date of the
publication of the reference of its amendment EN ISO 15223-1:2021/A1:2025, it is to say, until
17 June 2031.
This corresponds to a transition / coexistence period of 5 years during which the harmonised
standard EN ISO 15223-1:2021 with its amendment EN ISO 15223-1:2021/A1:2025,
providing for the ‘EU REP’ symbol, may be already used by manufacturers to comply with the
requirements of the MDR and IVDR, and at the same time the previous version EN ISO 15223-
1:2021 without the amendment EN ISO 15223-1:2021/A1:2025, providing for the ‘EC REP’
symbol, may continue to be used by manufacturers to comply with the requirements of the
MDR and IVDR as well.
During the transition time, within a staggered approach for the implementation, it is acceptable
to use one or both symbols ‘EC REP’ and ‘EU REP’ on different levels of packaging, as well
13 Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for
medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the
Council (OJ L 256, 19.7.2021, p. 100, ELI: http://data.europa.eu/eli/dec_impl/2021/1182/oj).
14 Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in
vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament
and of the Council (OJ L 258 20.7.2021, p. 50, ELI: http://data.europa.eu/eli/dec_impl/2021/1195/oj).
15 See in particular the meeting held on 4 February 2026 and the related documents in the “Register of
Commission Expert Groups and Other Similar Entities”: https://ec.europa.eu/transparency/expert-groups-
register/screen/meetings/consult?lang=en&meetingId=69791.
http://data.europa.eu/eli/dec_impl/2021/1182/oj
http://data.europa.eu/eli/dec_impl/2021/1195/oj
https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=69791
https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=69791
Medical Devices
Medical Device Coordination Group Document MDCG 2021-5 Rev. 1 - Appendix
Page 6 of 6
as re-labelling/over-labelling solutions, provided that the information on the authorised
representative remains clear and intelligible.
As from 17 June 2031, compliance with the applicable requirements of the MDR and
IVDR is granted only by the use of the harmonised standard EN ISO 15223-1:2021 with
its amendment EN ISO 15223-1:2021/A1:2025, providing for the ‘EU REP’ symbol for
authorised representatives in the Union. Devices using the ‘EC REP’ symbol already placed
on the EU market before that date may continue to be made available, as the change in the
harmonised standard does not concern health, safety or performance issues of the device16.
16 See also Section 4.1.2.5. of “The ‘Blue Guide’ on the implementation of EU product rules”: https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2022.247.01.0001.01.ENG.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2022.247.01.0001.01.ENG
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2022.247.01.0001.01.ENG
Background
The symbol for authorised representatives: from ‘EC REP’ to ‘EU REP’
Citation in the OJEU of EN ISO 15223-1:2021/A1:2025 and transition period
17.06.2026
Datei
PD
