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Inside the EU medical device regulation

After a one-year delay and much hand wringing by industry, the European Union’s Medical Device Regulation went into effect in May 2021. While device makers have resolved some of the near-term pressures, they still face a range of uncertainties and potential problems one year later.

included in this trendline
  • MDR updates safety, clinical performance requirement for high-risk devices
  • EU finalizes implementing regulation for Eudamed medical device database
  • EU task force calls for MDR legacy device surveillance requirements
Our Trendlines go deep on the biggest trends. These special reports, produced by our team of award-winning journalists, help business leaders understand how their industries are changing.
Davide Savenije Editor-in-Chief at Industry Dive.