MDR Preparation: Exhaustive list of requirements for manufacturers of medical devices

Manufactures obligations, as addressed in the 2017(745) Medical Device Regulation, have been compiled by MHRA into one single document, assisting as kind of a checklist during the transition from the MDD to the MDR.


This list summarizes the obligations under the topics:

  • General systems and process requirements
  • Conformity assessment and CE marking
  • Provisions concerning specific device types/activities
  • Requirements relating to UDI
  • Compliance with common specifications and harmonised standards
  • Clinical evaluation and clinical investigations
  • Post-market surveillance and vigilance