A step by step guide to compliance
The manufacturer has the main role in complying with the EU MDR. Considering that both the device and the manufacturer must comply with the EU MDR, the manufacturer has by far the largest number of obligations to fulfil.
The pages linked below describe a step by step approach to compliance which should be applicable to the majority of manufacturers and devices. There is no single formula however, and the described approach will likely require adjusting to the specifics of the manufacturer and device concerned.
Guidance
Guidance is also available from the Medical Device Coordination Group for manufacturers of Class I devices and custom made devices
- MDCG 2021-3 Questions and Answers on Custom-Made Devices.
- MDCG 2019-15 Rev1 Guidance notes for manufacturers of class I medical devices.