According to the EU Commission "this factsheet is aimed at manufacturers of medical devices" and is prepared to explain the background of the new MDR, as well as the major questions such as:
- What has changed?
- What does this mean in practice?
- Timing your transition to the new regulation
It is prepared in a way that people with a basic knowledge of the regulation are introduced to the major issues of the new chapter in European regulatory affairs.
Same is available as factsheet for IVDR.