HEALTH AND FOOD SAFETY

Pilot coordinated assessment for clinical investigations and performance studies (CI/PS): call for applications

In February 2025, the European Commission launched a call for applications for expression of interest to participate in an EU pilot coordinated assessment of clinical investigations (CI) and performance studies (PS) across multiple Member States as per Articles 78 of Regulation (EU) 2017/745 on medical devices (MDR) and 74 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), respectively.

The call is open until 30 June 2025.

For more, see the Commission’s web page on Clinical investigations and performance studies.

EMA regular procedure for scientific advice on certain high-risk medical devices

In February 2025, the European Medicines Agency (EMA) announced the establishment of a regular procedure for manufacturers to request scientific advice on the intended clinical development strategy for certain high-risk medical devices.

The advice procedure is available for two types of medical devices: class III devices: invasive and sustain or support human life; class IIb active devices: intended to administer or remove medicines.

Latest meetings of the Medical Device Coordination Group (MDCG)

The latest meetings of the Medical Device Coordination Group (MDCG) took place in December 2024 and in February 2025 with national competent authorities, including sessions with the sectorial stakeholders.

For more, see the information on the MDCG meetingon 17 to 18 December 2024, the meeting between the MDCG and stakeholderson 17 December 2024, the MDCG meeting on 18 to 19 February 2025 and the meeting between the MDCG and stakeholders on 18 February 2025 from the Register of Commission Expert Groups and Other Similar Entities.

The list of 2025 planned meetings of MDCG and Subgroupsis available from the Commission’s web page on Medical Device Coordination Group Working Groups.

List of views provided under the PECP

In November 2024, the European Commission issued the list of views in the context of the Performance Evaluation Consultation Procedure (PECP) by the expert panels on medical devices and in vitro diagnostic devices (Expamed).

For more, see the Commission’s web page on Expert panels.

Advice on SARS-CoV-2 on request from the Medical Device Coordination Group

In January 2025, the in vitro diagnostic medical devices (IVD) expert panel, on request from the Medical Device Coordination Group (MDCG), provided new scientific advice on SARS-CoV-2. This information may affect how SARS-CoV-2 tests are classified under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

For more, see the Commission’s web page on Expert panels.

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)

In February 2025, the Expert panels on medical devices and in vitro diagnostic devices (Expamed) published an Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP).

For more, see the Commission’s web page on Expert panels.

Updated notified bodies survey on certifications and applications (MDR/IVDR)

In October 2024, the European Commission issued the latest update of the notified bodies (NB) survey on certifications and applications under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It contains the results of the 10^th NB survey with data status 30 June 2024 (small and medium dataset).

For more, see the Commission’s web page on Notified bodies.

Factsheet for healthcare professionals and health institutions

In December 2024, the European Commission issued a revised and updated version of the Factsheet for healthcare professionals and health institutions.

For more, see the Commission’s web page on Guidance and useful information.

Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices

In December 2024, the European Commission issued a revised and updated version of the Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices.

For more, see the Commission’s web page on Guidance and useful information.

Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices

In December 2024, the European Commission issued a revised and updated version of the Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices.

For more, see the Commission’s web page on Guidance and useful information.

Revised MDCG 2022-5 on ‘Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices’

In October 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-5 rev.1 providing guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDR).