Navigating the many requirements set forth within the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) can be overwhelming for even the best-prepared medical device or IVD manufacturer.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies on a daily basis. Our internal team of nearly 100 global regulatory experts is partially comprised of authorities from five leading Notified Bodies—putting this knowledge and expertise to work for you—ultimately delivering clients accelerated and cost-efficient regulatory outcomes.

Do you have the right regulatory partner to help you meet compliance and stay ahead of the competition? Contact us today to learn the critical steps you should take now to achieve regulatory conformity and market success. 
NAMSA, in an effort to assist global medical device and IVD manufacturers with 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 MDR/IVDR regulations.
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MDR / IVDR Planning Resources

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:

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