France’s National Medicines Agency has established a pilot project to prepare for implementation of the new EU Medical Device Regulation and In Vitro Diagnostics Regulation.
The pilot project is focusing on new requirements for clinical investigations and the agency will work with industry stakeholders to ensure that authorizations for Class III implantable devices, and Class IIa and Class IIb invasive devices meet the new framework.
The MDD requires a clinical investigation authorization scheme for invasive Class IIa and Class IIb devices and Class III implantable devices as well as an ethical review of the CI at each member state. A single submission is required on the European EUDAMED database, which will gather information related to clinical trial and will be accessible to the public.
The regulation also requires that multi-site trials conducted in several member states have coordinated assessment procedures for applications and amendments as well as a single decision for each member state. This process is mandatory from May 26, 2027, and before that time as soon as the EUDAMED portal is operational.
Ongoing since November 2018, France’s pilot project has involved all stakeholders in order to define the different stages of the evaluation process on an organizational level as well as the solutions provided between the ANSM and the Human Protection Committees (CPP).
The ANSM reported that the pilot has strengthened relations with the CPPs.