MDR

Navigating the MDR Process

In Uncategorized by Michael WillisLeave a Comment

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

Webinars

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.

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