What is the new EU Medical Device Requirement (MDR) and what does it mean?

Adopted by the EU on 5 April 2017, the new MDR replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The three year transition period ends on 26 May 2020. After this date, all submitted materials must conform to the new MDR.

The new MDR changes the market access landscape for all member countries of the European Union, and it aims to ensure a higher  level of protection for patients and users.  Some key changes associated with the MDR include: 

Clinical Data - companies will need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards. 

Global Products - companies will need to rationalize their global product portfolios and perform a global impact assessment in order to implement the necessary changes to remain compliant.  

Are you ready for 2020?

RQMIS can help you find out.

Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below

Contact

Back to News Room

Ready to get started?

We’ll drop you a line and start a conversation. Just put in your email. We won’t spam you.