MDR (Medical Device Regulation)

In about 3 months, the MDR will come into force. Much remains to be done. If Switzerland has not a finalized Mutual Recognition Agreement which is a part of the bilateral agreements, Swiss medical device manufacturers needs to define an EC Authorized Representative (Economic Operator), which is located in an EU country . From May 26, 2021, medical devices must be certified according to MDR regulations. Devices still certified under the MDD may be placed on the market until May 2024 if no significant changes are made.