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