The European Union’s Medical Device Regulation (EUMDR) was officially published in May 2017. The EUMDR replaces the EU’s Medical Device Directive (MDD) and the EU’s Directive on active implantable Medical Devices. Beginning in May 2021, new devices will have to meet the requirements of the MDR to be marketed in Europe. Devices holding a certificate from a European Notified Body under either the MDD or the Active Implantable Medical Devices Directive have an additional grace period and may continue to be marketed until May 26, 2024, as long as the manufacturer fulfils the specific prerequisite requirements drawn in the MDR.
Some of the key changes in the MDR include:
- Product scope expansion of MDs and active implantable MDs to include devices that do not have a medical intended purpose.
- Reclassification of devices according to risk, contact duration and invasiveness.
- More rigorous clinical evidence for class III and implantable medical devices.
- Systematic clinical evaluation of Class IIa and Class IIb MDs.
- More stringent documentation.
- Identification of ‘person responsible for regulatory compliance’.
- Implementation of unique device identification for better traceability and recall’
- More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices
- Greater Scrutiny of Notified Bodies
- No “grandfathering” provisions i.e., all currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements.