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.
Presently a working group consisting of the CCMO, the Dutch association of MRECs (NVMETC), the society for medical physics in the Netherlands (NVKF) and the Dutch society for sterilization experts (vDSMH) are working on the development of a guideline for MRECs. The Health and Youth care Inspectorate (IGJ) is observer at this working group. The guideline is specifically intended for the accredited MRECs responsible for the assessment of clinical investigations using medical devices, but also contains information that is useful to researchers and research sponsors. This guideline describes specific topics for the review of clinical investigations with medical devices. The guideline will be published at the CCMO website.