Newsletter CCMO: Consequences of the medical device regulation on clinical investigations

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.

Availability CCMO during holiday season

CCMO is closed from Wednesday the 25th of December up to and including Friday the 27th of December 2019 due to the holiday season. The availability of CCMO by telephone and email is reduced from Monday the 30th of December 2019 up to and including Friday the 3rd of January 2020. From Monday January 6th 2020 CCMO will be fully operational again.

CCMO wishes you happy holidays and all the best for 2020!

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This newsletter is published by the Central Committee on Research Involving Human Subjects (CCMO).

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