[Regulatory path of the medical device]

Regulatory path of the medical device. The safety of medical devices (MD) is recognized by the CE marking allowing their free circulation on the European market. The new European regulation will reinforce the application and the survey of MD. For implantable MD, clinical data will be required, and the traceability will be facilitated by the implementation of a unique identifier. The safety of MD is under the European governance responsibility, while the circulation, the reimbursement and the survey of MD is under the responsibility of each country. In France, the evaluation of the clinical benefit and conditions of use of MD reimbursed is under the responsibility of a specific commission of the HAS, while their surveillance is under the responsibility of the ANSM.