With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. But what is going to change? And how are these changes to be implemented? The EU published two documents regarding both those questions:
Factsheet for Manufacturers of Medical Devices
In a five-page “Factsheet for Manufacturers of Medical Devices“, the EU briefly describes the reasons behind the changes, the changes being made and their consequences in practice. It also outlines implementation deadlines and answers frequently asked questions.
How are the changes to be implemented?
For this purpose, the EU published an exemplary recommendation as a step-by-step guideline (“Implementation Model for Medical Devices Regulation“). The equally brief two-page document describes a possible implementation in twelve steps. It includes preliminary considerations, a GAP analysis as well as monitoring after the changes have been implemented. Special emphasis is put on the timely involvement of the appointed notified bodies in order to ensure their capacities and avoid delays during the approval process. The Quality Management System (QMS) is also discussed. New requirements for QMS must be implemented and the “person responsible for regulatory compliance” must be integrated in the system. It should also be ensured that this person is adequately qualified and trained.