The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.

Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the EU’s previous Directives: the Active Implantable Medical Devices Directive (AIMDD), Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD).

These lengthy documents can be cumbersome to navigate, particularly when trying to understand how the new regulations compare to the previous directives—and more importantly, the critical steps that manufacturers should undertake now to ensure conformity by May 2020 (MDR) and May 2022 (IVDR), respectively.

NAMSA, in an effort to assist global medical device and IVD manufacturers with their compliance planning, has made available several complimentary resources which can be found below.

We hope you find these tools to be beneficial as you prepare for implementation of the new regulations.

Guidance Documents

In July 2018, the EU Commission issued the following “Information to Manufacturers” in an effort to provide further clarity on new regulatory changes and implementation models to address the regulations:

White Papers

Webinars

Regulatory Pulse Blog

How can NAMSA Help?

NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to the new EU MDR and IVDR regulations, including the critical steps you should be taking now to realize successful outcomes.

Please contact us at clientcare@namsa.com or visit our regulatory consulting webpage here to learn about our services.