Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation
The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as part of the targeted evaluation of these rules. The consultation provides stakeholders with the opportunity to express their views on how the current rules are performing and to highlight possible shortcomings. The consultation and call for evidence will be open until 21 March 2025 and are accessible here.
MDCG 2023-3 rev.2 - Questions and Answers on vigilance terms and concepts
MDCG has issued an update to MDCG 2023-3 rev.2 - Questions and Answers on Vigilance Terms and Concepts under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), dated January 2025. This document clarifies key terms and concepts from Section 2 of Chapter VII of the MDR and IVDR, incorporating relevant updates from the Guidelines on a Medical Devices Vigilance System with modifications for alignment.
Key updates are to Q1 has been amended to align with Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. Question 2 Reference to ‘Eudamed vigilance (VGL) module’ is amended to ‘Eudamed Postmarket surveillance and Vigilance module (VGL module)’. Footnote 34 ’48 working hours’ replaced with ‘allow 48 hours (equivalent to two weekdays)’.
The guide is available here.
Combined studies and COMBINE strategy
December 16th, 2024 EU National authorities in Member States have endorsed a new strategy for the COMBINE program, (a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics).
The strategy can be found on the Commission’s webpage: Combined studies and COMBINE strategy
The COMBINE program will be rolled out over the coming years through seven cross-sector projects. Among the goals of this program are to:
- Pilot a single assessment process for multi-country combined studies across device and medicinal product regulations
- Harmonise serious adverse event reporting processes
- Clarify questions on the interface between clinical trials and medical device regulations
- Explore new opportunities for advising sponsors and facilitating knowledge exchange among national authorities
Pilot coordinated assessment for CI/PS
Member States, supported by the European Commission, have launched a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Article 78 of the EU MDR and Article 74 of the IVDR.
This pilot will allow sponsors to submit a single application for pilot-coordinated assessments, assuring more harmonized interaction with the Member States approving the clinical investigation or performance studies.
It is hoped this pilot will help put in place a fast and fit-for-purpose EU system for coordinated assessment once its mandatory operation starts. The aim is to implement a harmonized, predictable process across Member States, reducing administrative burden for sponsors and ensuring high transparency and consistency in the coordinated assessment.
Advice on SARS-CoV-2 on request from the Medical Device Coordination Group
The IVD expert panel has provided new scientific advice on SARS-CoV-2. This information may affect how SARS-CoV-2 tests are classified under the EU IVR. Manufacturers are encouraged to assess how this advice impacts their devices and consult with their notified body as to the conformity assessment steps to be taken in case of a change in risk class.
The MDCG guidance on IVD classification (MDCG 2020-16) is being updated to reflect this advice.
Revised versions and new guidance are available in the EMDN section
There are a number of updates to guidance in the European Medical Device Nomenclature (EMDN) as follows:
MDCG 2025-3: EMDN Version History
MDCG 2025-2: Summary of EMDN 2024 Submissions and outcome of annual revision
MDCG 2025-1: EMDN Ad hoc procedure
MDCG 2024-2 rev.1: Procedures for the updates of the EMDN
MDCG 2021-12 rev.1: FAQ on the European Medical Device Nomenclature (EMDN)
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