List of EMDN Codes Has Been Updated, Plus New & Revised MDCG Documents on EMDN
29 January 2025
MDCG 2019-6 Rev. 5: Clarifies Notified Body ‘Structured Dialogues’ with Manufacturers
11 February 2025Below is an overview of the January 2025 news items that were not already individually reported. Please see our Regulatory Updates main page for those topics, e.g., the list of EMDN codes has been revised, the MHRA released new guidance on the upcoming PMS legislation, and more.
Commission/Competent Authority Updates
Harmonized Standards for AI Act
The Commission published a draft proposal to amend Implementing Decision C(2023)3215, which is on the development of harmonized standards for the AI Act. It is available: HERE
The Commission proposes the following changes:
- The CEN and CENELEC
September 2024 report advised significant delays on implementing the harmonized standards outlined in C(2023)3215. Therefore, it is proposed that CEN and CENELEC:
- Submit a revised work programme within two months of the amendment’s adoption
- Provide the Commission with a joint final report by 31 August 2025 (instead of 30 April 2025)
- Provide a detailed status report every three (3) months instead of every six (6) months and “provide detailed evidence of their best efforts to fulfill this Decision and deliver harmonised standards and standardisation deliverables listed in Annex I”
- The Implementing Decision shall expire 28 February 2027 (instead of 28 February 2026)
- Annex II is revised to ensure harmonised standards fully align with the final AI Act, incorporating essential requirements related to risk management, transparency, and compliance verification
- Other general updates, e.g., all references to the ‘Artificial Intelligence Act proposal’ shall be replaced by the ‘Artificial Intelligence Act’
No changes are proposed to the list of deliverables outlined in Annex I of C(2023)3215.
HTA Rolling Plan
The rolling plan on the Health Technology Assessment (HTA) regulation has been updated. It is available: HERE
For more information on the HTA and the rolling plan, please read: Health Technology Assessment (HTA) Regulation
HTA Joint Assessment Open Consultation
Last year the Commission opened a public consultation on Joint Scientific Consultations (JSCs) under the Health Technology Assessment (HTA) regulation. It ran from 29 October 2024-26 November 2024. The feedback is available: HERE
Master UDI-DI
The Commission opened a new ‘Have Your Say’ initiative to introduce Master UDI-DI for Spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. The details are available: HERE
The consultation period is 30 January 2025 – 27 February 2025 (midnight Brussels time)
IVD Expert Panel on COVID Devices
In February 2024, Team Notified Body published a Position Paper recommending down-classifying SARS-CoV-2 devices from Class D (highest risk).
Last week the IVD Expert Panel published its scientific advice on the subject, published: HERE
The IVD Expert Panel’s position advises that “while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.”
Further, that “MDCG guidance on IVD classification (MDCG 2020-16) is being updated to reflect this advice.“
EU Reference Laboratories (EURLs)
As of 1 January 2025, the first six EU Reference Laboratories (EURLs) have been operational and will now carry out activities for the next seven years. More information is available: HERE
France Derogation Procedure
The French Competent Authority ANSM has streamlined the process to request Derogations: HERE
Starting January 27, 2025, manufacturers must use a new simplified application form for these requests. Note that this is only applicable to medical devices. ANSM will shortly release a separate form specific to IVDs.
Swissmedic IVD Ordinance
The amendment to the Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDO) entered into force on 1 January 2025: HERE
This amendment is the formal update to incorporate Regulation (EU) 2024/1680, which extends the IVDR transition period. That said, as noted in August 2024, Swissmedic has already been operating under Regulation (EU) 2024/1680 while the Swiss legislation underwent revision, i.e., the above does not change the process, it only formalizes it.
Swissmedic further confirmed that the legislative change does not include the new MDR/IVDR Article 10a requirement to notify of the interruption or discontinuation of the supply of certain medical devices.
MDCG Updates
MDCG Guidance Revised
The below MDCG documents were revised. The below are primarily related to the designation process for Notified Bodies under the MDR and IVDR, i.e., they do not have an immediate impact on manufacturers or other economic operators under MDR or IVDR.
| Reference | Title | Publication |
|---|---|---|
| MDCG 2024-7 rev.1 MDCG 2021-15/MDCG 2024-7 Annex | Preliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents) | January 2025 |
| MDCG 2024-8 rev.1 MDCG 2021-16/MDCG 2024-8 Annex | Preliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents) | January 2025 |
| MDCG 2021-16 rev.1 MDCG 2021-16/MDCG 2024-8 Annex | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) Annex to Application Form & PAR Template IVDR (List of documents) | January 2025 |
| MDCG 2021-15 rev.1 MDCG 2021-15/MDCG 2024-7 Annex | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) Annex to Application Form & PAR Template MDR (List of documents) | January 2025 |
MDCG UDI Working Group Meeting Minutes
The MDCG UDI Working Group published minutes from their 29 October 2024 meeting: HERE
Topics discussed include:
Master UDI-DI for contact lenses: Industry requested a one-year extension to the date of application for Master UDI-DI on contact lenses (Commission Delegated Regulation (EU) 2023/2197). It is currently scheduled to become effective starting 9 November 2025. Reasons cited include problems faced by manufacturers in complying with the new provisions, as well as some delay in the development and publication of guidance. The consensus was to consider this request; however, that in case of vigilance, manufacturers must promptly assign a Master UDI-DI.
Master UDI-DI for spectacle frames, spectacle lenses, and ready-made reading spectacles: the draft Commission Delegated Regulation has been prepared for circulation and consultation. Once the Delegated Regulation on spectacle frames is adopted, a supporting guidance document will be developed.
UDI Rules in case of mergers and acquisitions: MedTech Europe raised issues on UDI assignment rules for mergers and acquisitions. Based on the new document and spreadsheet submitted by MedTech Europe, the Commission will draft a skeleton of requirements and circulate it among Competent Authorities for further discussion.
UDI for devices under a distributor’s brand name: There was some discussion (and dissent) among the Competent Authorities on the appropriate process. The Commission will launch a consultation among Competent Authorities and publish the agreed common position in the UDI Helpdesk.
IMDRF Updates
IMDRF/AIML WG/N88 FINAL: 2025
The IMDRF published a new technical document on ‘Good machine learning practice for medical device development: Guiding principles’: HERE
The document is a “call to action to international standards organizations, international regulators, and other collaborative bodies to further advance GMLP”.
The 10 guiding principles are provided below. Please refer to the guidance for further detail on each items.
| 1. The intended use/ intended purpose of the device is well understood, and multi-disciplinary expertise is leveraged throughout the total product life cycle |
| 2. Good software engineering, medical device design, and security practices are implemented throughout the total product life cycle |
| 3. Clinical evaluation includes the use of datasets that are representative of the intended patient population |
| 4. Training datasets are independent of test sets |
| 5. Selected reference standards are fit-for-purpose |
| 6. Model choice and design are tailored to the available data and the intended use/ intended purpose of the device |
| 7. The device is assessed with a focus on human-AI interactions in the intended use environment, including the performance of the human-AI team, rather than just the device in isolation |
| 8. Testing demonstrates device performance during clinically relevant conditions |
| 9. Users are provided clear, essential information |
| 10. Deployed models are monitored for performance and re-training risks are managed |
IMDRF/SaMD WG/N81 FINAL: 2025
The IMDRF published a new technical document on ‘Characterization Considerations for Medical Device Software and Software-Specific Risk’: HERE
The purpose is to help identify medical device software characteristics, which then helps to better identify and assess risks. This characterization process can help not only risk management, but also classification, and proper device use throughout the total product lifecycle.
Characterization of medical device software should clearly describe:
- what the device is,
- what it is intended to do, and
- how, where, when, and by whom the software is intended to be used and modified/changed.
