Team Notified Body: New MDR Training Session Available February 12, 2025
16 December 2024
Switzerland Negotiations with Europe Substantively Concluded, Now Ready for Formal Conclusion
20 December 2024Meeting Minutes & Agenda Links
The following MDCG Working Groups (WG) recently published Meeting Minutes:
The Agenda & Working Documents for the following meeting were published:
MDCG Main WG Meeting 14-15 October 2024
There were two sets of meetings; one with, and one without, stakeholders present. The meeting agenda, minutes, and presentations were uploaded. Below are some notable highlights from the meetings.
Targeted Evaluation of the MDR/IVDR
A very hot topic these days. A presentation on the state of the MDR/IVDR is available: HERE
In the minutes, MDCG members expressed strong concerns re: any quick fixes for MDR/IVDR legal amendments. However, the need for urgent actions within the current regulatory framework was acknowledged.
EU Reference Laboratories (EURLs)
EURLs are nominated by member states and designated by the EU Commission. Their role is in the verification of performance studies, batch testing, scientific and technical advice, and development of testing protocols for certain high-risk IVDs.
A second call for EURLs, in the scopes of parasites and blood grouping, will be launched: HERE
- Launching by the end of 2024
- With 11-12 months for candidate laboratories to apply
- Designation taking place in the second half of 2026
- Any newly designated laboratories would join the Union contribution funding cycle for the already existing EURLs
COMBINE Programme
The COMBINE Programme is the EU initiative aimed at streamlining the conduct of combined studies involving medicinal products, medical devices, and IVDs.
The Commission updated MDCG members about the proposed COMBINE Programme strategy: HERE
Health Technology Assessment (HTA) Regulation
The HTA Regulation (HTAR) helps standardize the clinical assessment of new health technologies (primarily medicines and certain high-risk medical devices), to inform reimbursement decisions. Further, the HTAR establishes a framework for Joint Scientific Consultations (JSCs), which can advise on the clinical evidence needed both to 1) demonstrate value from a health technology assessment and reimbursement perspective, and 2) a regulatory standpoint. I.e., while manufacturers must still work with their Notified Body on clinical evidence for CE Marking, the introduction of JSCs helps manufacturers better align their clinical evidence to include both regulatory and reimbursement expectations, from the start.
The Commission presented a general update on the HTAR before it enters into application in January 2025: HERE
Progress on Harmonized Standards
The Commission updated the MDCG members on the latest standardization developments: HERE
- Lack of harmonized standards was recognized as a significant problem in MDR/IVDR implementation:
- MDR: 26 standards harmonized (9% of all requested)
- IVDR: 15 standards harmonized (31% of all requested)
- Ongoing actions to improve the situation were outlined
Survey on eIFUs Results
The Commission recently launched a survey on the feasibility of electronic instructions for use (eIFUs) for all professional use medical devices.
An update on eIFU Survey was provided (page 3): HERE
87% responded that they would prefer using electronic instructions for use if available to them.
IMDRF Meeting Recap (and EU Action Items)
An overview of the recent IMDRF meeting, including on MDSAP to MDR/IVDR mapping was provided (page 8): HERE
Artificial Intelligence (AI) Act
The Artificial Intelligence Act (Regulation (EU) 2024/1689) entered into force August 1, 2024, followed by a phased transition period. The general applicability date for most provisions of the Act does not go into force until August 2, 2026.
The Commission provided an update on the oversight and enforcement of the AI Act: HERE
Updates & Concerns from Stakeholders
Various stakeholders, such as Team NB and MedTech Europe, provided updates and feedback regarding the MDR/IVDR implementation: HERE
- Team NB noted the need to improve EU-wide classification disputes (page 4), more practicality and consistency in guidance documents (page 5), and their resource struggles related to the “employed by” requirement (page 6)
- Medtech Europe noted the long EU QMS certification timing average of 19.5 months (page 3) and the near doubling of certification fees (pages 4-5)
MDCG EUDAMED WG Meeting 25 October 2024
Below are some notable highlights from the meeting.
EUDAMED Audit Status and Results
The audit for the Actor, UDI/Devices, and NB & Certificates modules started in August 2024. All had a high pass rate and the auditor’s findings are being addressed.
The above is important because each module must first pass an independent audit, before its use can be made mandatory.
The Market Surveillance module was actively undergoing audit as of October 2024.
Concerns were raised regarding the audit acceptance of the Vigilance module, particularly following the negative feedback from the Conformity Assessment Board. The Commission reminded that the mandatory use of the Vigilance module is not anticipated until six months after the other four modules. And they allow for the possibility of a re-audit, if necessary, while still aiming to maintain the planned mandatory use date.
2025 Planning
- The onboarding activities will become a key focus, as it is essential to provide adequate supporting materials to frame the onboarding activities.
- Financial support has been secured in order to translate the user guides and user interface into 23 languages.
MDCG Annex XVI WG Meeting 7 November 2024
Background: MDR Annex XVI addresses products without an intended medical purpose. These are products that may affect the human body similarly to medical devices, but are used for non-medical reasons. For example, colored contact lenses and lasers intended for hair removal. It was introduced to ensure non-medical devices affecting the body are safe. While this improves consumer protection, it poses challenges for manufacturers entering, or staying in, the EU market.
Below are some notable highlights from the meeting.
Impact of EU Parliament’s Vote to Revise MDR/IVDR
The Commission noted that EU Parliament’s resolution adopted to revise the MDR/IVDR does not make any specific reference to products covered under Annex XVI.
One member state advised that Annex XVI could also be addressed under the MDR/IVDR amendment. However, the Commission stressed that any proposal for amending Annex XVI needs to be justified.
Current State of Play
There are 300+ Notified Body applications being processed and 20+ certificates have been issued.
Challenges
Presentations were given on some of the challenges of implementing Annex XVI, e.g., conducting a benefit-risk analysis as requested by EN ISO 14971:2019, and labeling compliance (not sufficient space on labels to add required text + translations).
As well, on the lack of clarity on classification criteria, e.g., how to define “high intensity” in the context of Annex XVI, and whether certain products are or are not covered by Annex XVI, such as home use micro-needling pens.
Also mentioned is the high number of products circulating on the market, in which the manufacturer is not aware of Annex XVI and that these products now fall under the MDR.
Industry group APPLiA noted that during the transitional periods set out in Commission Implementing Regulation (EU) 2022/2346 on Annex XVI common specifications, manufacturers are continuing to place new devices on the market or make significant changes to those already marketed. APPLiA will publish a white paper for consumers regarding this.
Plans for 2025
- The next subgroup meeting is likely to occur one year later (Nov 2025).
- There are no active work items for 2025 unless priorities change.
- The current action item, to revise the Q&A document on transitional provisions, is on hold.
- The call of Competent Authorities (CAs) will continue to be organized every 2-3 months, to allow CAs to share experiences. These will be documented and used if relevant for new work items.
MDCG Main WG Meeting 17-18 December 2024
The meeting agenda and working documents outline some of the following discussion items to occur in the meetings.
Status on Harmonized Standards & MDCG Guidance
The Commission initiated a mapping project between the MDCG and the CEN-CENELEC Technical Committees. The purpose is to identify possible synergies, avoid duplication, and keep each group informed of initiatives. As part of this exercise, both groups shared an overview of all work items and their statuses, which we outline below.
Status of Harmonized Standards for the MDR/IVDR: HERE
- Adopted and to be published (non-exhaustive): EN 60601-1; EN ISO 18113-1, -2, -3, -4, -5 on IVD labeling; EN 556-1 on sterilization of medical devices to be designated “STERILE”; EN ISO 21535 & EN ISO 21536 for non-active surgical implants – joint replacement implants (hip & knee specific requirements)
- Final state for adoption (non-exhaustive): EN ISO 14630 on non-active surgical implants (general requirements); EN 556-2 on sterilization of medical devices to be designated “STERILE”; EN 14683 on medical face masks requirements and test methods
- Planned (non-exhaustive): EN ISO 5840-1, -2, -3 Cardiovascular implants – Cardiac valve prostheses; EN 13532 General requirements for self-test IVDs; EN ISO 15001 Anaesthetic and respiratory equipment – Compatibility with oxygen
Status of MDCG guidance (and other documents in support of the MDR/IVDR): HERE
- For revision (non-exhaustive): MDCG 2021-24 on classification of medical devices; MDCG 2019-11 on qualification and classification of software; MDCG 2021-12 on EMDN codes; MDCG 2020-5 on clinical evaluation equivalence.
- For new development (non-exhaustive): legal status of app providers; FAQ on interplay between MDR/IVDR and AI Act; Research Use Only IVDs; Q&A/guidance on distance sales; tool for EMDN definitions.
- To archive (non-exhaustive): MDCG 2019-4 on timelines for registration of device data elements in EUDAMED; MDCG 2019-5 on registration of legacy devices in EUDAMED; MDCG 2020-2 rev.1 on Class I transitional provisions under MDR Article 120 (3 and 4)
The following Casus resource will be updated as standards are newly harmonized: List of Common Specifications and Harmonized Standards under the MDR/IVDR
Other Agenda Items
The following topics will also be discussed:
- MDR/IVDR state of play, including “what short-term measures under the current regulatory framework could further facilitate MDR/IVDR implementation?”
- Update on EMDN
- Documentation for endorsement, including EMDN version 2024 and supporting documents (FAQ & ad hoc procedure template)
