Medical device

From prototype to post-market follow-up: a medical device follows its own journey, paced by its risk class. The clinical investigation demonstrates safety and performance in humans, ahead of CE marking and throughout post-market clinical follow-up.

Regulatory frameworks

• WorldwideISO 14155 (good clinical practice for device investigations) · IMDRF: convergence of risk-based classifications · in the United States: IDE procedure (FDA/CDRH) for significant-risk investigations, then 510(k) or PMA
• European UnionRegulation (EU) 2017/745 (MDR), applicable since May 2021 — Regulation (EU) 2017/746 (IVDR) for in vitro diagnostics · no marketing authorisation: CE marking by a notified body, then post-market clinical follow-up (PMCF) · national clinical investigation applications
• FranceLoi Jardé · non-CE-marked device: ANSM authorisation + ethics committee (CPP) opinion — RIPH 1 · CE-marked device used within its intended purpose: lighter procedures depending on the ANSM category
• BelgiumLaw of 22 December 2020 on medical devices and Royal Decree of 18 May 2021 on clinical investigations · assessment by the FAMHP and an accredited ethics committee