Küsimused

Dear CIEPSE WG Members,

I hope this email finds you well.

This is a kind reminder for the completion of the surveys initiated by COMBINE Project 2, to gather information on MDR/IVDR national safety reporting requirements across Member States.

Please find the surveys linked below:

• Survey on national safety reporting routes and requirements for clinical investigations: https://ec.europa.eu/eusurvey/runner/Safety_reporting_routes_requirments_MD

• Survey on national safety reporting routes and requirements for performance studies: https://ec.europa.eu/eusurvey/runner/Safety_reporting_routes_requirments_IVD

COMBINE Project 2 will use your input to develop a document where the MDR/IVDR safety reporting requirements across the various EU Member States are listed in an easy, accessible manner. This will enable sponsors of combined multinational studies to easily find the reporting requirements applicable to their study.

While the initial deadline was on 7 November, we kindly ask you to submit your responses the soonest possible, with the final deadline being on 26 November 2025. As this email is sent to the CIEPSE WG members and alternates nominated for your Member State, please coordinate to make one consolidated submission for the CI survey and one consolidated submission for the PS survey respectively.

If you have any queries related to the surveys, please contact the COMBINE Project 2 leads, Annemie and Corina (in Cc).

Your participation would be much appreciated.

Kind regards,

On behalf of the CIEPSE Chairs

Mantalena Kyprianou
Policy Officer
 
European Commission
Directorate-General for Health and Food Safety (DG SANTE)
Medical Devices (SANTE.D.3)

F101 08/070
B-1040 Brussels/Belgium

[email protected]