Medical Devices: EU-MDR

Medical Devices: EU-MDR

EU-MDR

The European Medical Device Regulation 2017/745 (MDR) is a new set of regulations applicable to all medical devices intended to be marketed in the EU, replacing the previous Medical Device Directives (MDD) and Active Implantable Medical Devices Directive (AIMD).

Summary of Key Dates for Manufacturers
1. May 2017 , MDR was issued with the first effective date of May 2020.
2. May 2020, the effective date of MDR has been postponed for 1 year due to the Covid pandemic.
3. May 2021, MDR becomes enforceable and enforceable. All new devices or devices with expired certificates should now be MDR compliant.
4. December 2027, all Class IIB and Class III device certificates issued under the previous directives and which have not yet expired will expire.
5. By December 2028, all Class I and Class IIA device certificates issued under previous directives that have not yet expired will no longer be valid. All medical devices marketed in the EU must now carry the MDR CE certification.