Navigating the MDR Process

In Uncategorized by Michael Willis2 Comments

There are new requirements established by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) including expanded clinical evidence requirements, more regulatory oversight, additional requirements for IVD manufacturers, and stricter supervision of Notified Bodies.

To help guide companies through what may be a challenging process of navigating the new regulations, a number of documents have been compiled by NAMSA and are available for review.

They include:

Guidance Documents

White Papers


Regulatory Pulse Blog

While not exhaustive, this should list provide a helpful guide for device manufacturers required to re-certify their products in the EU.

Please follow and like us: