How the New EU Medical Device Regulation Will Change Your Approach to CE Compliance

What You Need to Know

The new Medical Device Regulation (MDR 2017/745) represents a seismic change in how medical devices are regulated in the EU. Complying with the new regulation presents a whole new set of challenges for RA/QA professionals, and it is key to understand those changes and develop a sound transition strategy.

In this Market Update we explore 7 ways the new EU MDR will change your approach to CE compliance and explore areas to consider so as to ensure sustained compliance.

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