medical devices

As of 26th May 2021, the Medical Device Regulation, 2017/745 (MDR) is fully implemented.

Important changes that medical device manufacturers need to be aware of are:

  • Class I medical devices registered under the Directive 93/42/EEC (MDD) which stay in class I under MDR may not be placed on the market or put into service any longer.
  • Those in class I medical devices under MDD which will be in higher classes under MDR may be placed on the market or put into service until 26 May 2024 under certain conditions.
  • All new medical devices need to pass a conformity assessment procedure in accordance with the MDR.
  • MDR requirements relating to post-market surveillance, market surveillance, and vigilance apply for all medical devices.
  • All economic operators have to register to EUDAMED via the actor registration module to receive a Single Registration Number (SRN).
  • The Mutual Recognition Agreement between the EU and Switzerland has not been prolonged. Thus, Switzerland is now considered a 3rd country with regard to the MDR. What does this mean for both sides?
    • Swiss manufacturers need an EU Authorized Representative to act on the European market
    • European manufacturers need a Swiss Authorized Representative to act on the Swiss market.

With our regulatory expertise and our excellent network, we can offer solutions to these issues, contact us.