27 May 2021

New regulation on medical technology

As of 26 May, all relevant actors are obliged to fully conform to the new EU regulation on medical technology. The regulation, called MDR, aims to strengthen patient safety for medical devices and to improve traceability in the supply chain.

It is mainly the following actors who are currently affected by the requirement to adhere to MDR:

  • Class I medical device manufacturers.
  • Authorized representative of Class I manufacturers.
  • Importer of Class I medical devices.
  • Manufacturers of customized medical devices.
  • Manufacturers of self-made products.
  • Parties that assemble and release modular products and care sets

Do you need legal advice regarding MDR and related legislation? Contact Mina Gholiof.