The MDR will replace the existing Medical Devices Directive (93/42/EEC) [MDD] and the Active Implantable Medical Devices Directive (90/385/EEC) [AIMDD]. The MDR was published in May 2017, marking the start of a 3-year period of transition from the MDD and the AIMDD.
In contrast to the Medical Devices Directives (MDD), the Medical Devices Regulations (MDR) are directly applicable and do not need to be transposed into national law. This means the regulations lower the risks of discrepancies in interpretation across the EU.
The new regulations will improve the quality and safety of devices on the EU market. In particular:
- reinforce the criteria for the designation of notified bodies and processes for their oversight
- introduce stricter pre-market control of high-risk devices
- strengthen post-market surveillance.