ANSM has set up a “pilot phase” to prepare for MDR. The pilot will simulate the new organisation imposed by this regulation while respecting the current regulations.
The application of EU Regulation No. 2017/745 (the Medical Devices Regulation, MDR) imposes new working methods for competent authorities and the ethics committees of the Member States (for the clinical investigation part). The regulation will come into effect the 26th May 2020 including Chapter 6 which concerns clinical evaluations and investigations of medical devices, understood by ANSM as “any systematic investigations involving one or more participants to assess the safety or performance of a medical device”.
- France is the first EU country to launch a pilot phase to prepare for the EU regulation
- Participation in the pilot phase is voluntary
The project has been been in development since November 2018, and is run by ANSM – Agence Nationale de Sécurité du Médicament et des Produits de Santé (the National Agency for Medicines and Health Products Safety) .
Access more information on the “pilot phase” and how to participate here.