The Medical Device Regulation (MDR) came into force in May 2017. By May 26th of 2021, all European medical device manufacturers and other economic operators (e.g. distributors) need to have implemented the principles of the MDR.
It can be difficult to distinguish between documenting the necessary and documenting too much.
Therefore, below you can find a checklist of mandatory documents to comply with the MDR.
Do you need support with implementing all applicable requirements for MDR compliance? Contact QbD.