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European Medical Device Regulation


A Beginner’s Guide to European Medical Device Regulation

After a one-year delay, time is running out to prepare for the European Medical Device Regulation (EU MDR). Starting May 26, 2021, companies must adhere to the new regulations governing the production and distribution of medical devices in Europe, which replace the Medical Devices Directive (MDD).

In this guide you will learn:

  • What counts as a medical device?
  • The role of literature management in EU MDR compliance
  • How much clinical data is enough?

In this guide, we’ll look at some critical changes related to information management—and offer tips for simplifying compliance.