Some of the key changes include:
- Product scope expansion. The definition of medical devices and active implantable medical devices will be significantly expanded to include devices that do not have a medical intended purpose and devices designed for the purpose of “prediction” of a disease or other health condition.
- Reclassification of devices according to risk, contact duration and invasiveness. The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
- More rigorous clinical evidence for class III and implantable medical devices. Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device.
- Systematic clinical evaluation of Class IIa and Class IIb medical devices. Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
- 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. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements.
