Consequences of the medical device regulation on clinical investigations
As of May 26th 2020, the European Medical Device Regulation (EU) 2017/745 (MDR) comes into effect. The MDR brings new rules for submission, review and conduct of clinical investigations with medical devices.
In the ensuing months, the CCMO will inform you of the changes and practical consequences this regulation entails. Currently, the CCMO website offers information on the major changes, the different legal frameworks for clinical investigations, the tasks of the National clinical trial office of the CCMO and the MRECs and the transitional provisions.