E.U. MDR

(European Union Medical Device Regulation)

Medical device manufacturers seeking market access to the European Union (EU) face major changes in the EU’s decades-old regulatory framework. The Medical Device Regulation (MDR) replaces the EU’s previous Medical Device Directive (MDD) and the EU’s Directive on active implantable medical devices.

Summary

The changes and their impact The MDR differs in several important ways from the EU’s previous directives for medical devices and active implantable medical devices. Changes in the regulation include expansion of the scope of products covered, more rigorous requirements for clinical evaluation including changes to clinical investigations, mandatory unique device identification (UDI) mechanisms, and increased post-market oversight by EU Notified Bodies.
The new EU MDR imposes strict demands on medical device manufacturers and the Notified Bodies whom they must involve in the approval process of medical devices other than self-declaration class I devices.
Device manufactures will select and work with their EU Notified Body to authorized to provide certification services under the new regulation. The Project can provide additional support to work as a mediator between the medical device manufacture and the notified bodies.