Manufacturers will need to generate and provide more rigorous clinical data for class III and implantable medical devices where existing data is considered insufficient.

Manufacturers will need to generate and provide more rigorous clinical data for class III and implantable medical devices where existing data is considered insufficient.

There is no grandfathering of products. The MDR requires that all currently approved devices must be re-certified in accordance with the new requirements.

Device manufacturers will be required to identify and appoint at least one person who is ultimately responsible for ensuring compliance to the MDR.

The MDR requires the use of a unique device identification (UDI) mechanism. Manufacturers will be required to report medical device related incidents, injuries or deaths.

The MDR will grant Notified Bodies increased post-market surveillance authority. Unannounced audits of manufacturers, together with product sample checks and testing.

The MDR legislates that the common specifications (CS) are to be defined and published by the EU Commission or expert panels. These common specifications shall exist in parallel to the harmonized standards for medical devices and the state of the art.