List of MDR requirements for manufacturers!

The European Commission has published the list of requirements under the MDR that was prepared by the UK MHRA.

14-pager presents exhaustive list of obligations for economic operators, while placing particular focus on manufacturers regarding:

  • General systems and process requirements

  • Conformity assessment and CE marking

  • Provisions concerning specific devices types/activities

  • Requirements relating to UDI

  • Compliance with common specifications and harmonised standards

  • Clinical evaluation and clinical investigations

  • Post-market surveillance and vigilance

You can find other useful documents here, which will help you better understand the new Regulation.

Leave a Reply

Your email address will not be published.