On May 26th 2021, the European Medical Device Regulation (EU) 2017/745 (MDR) will apply resulting in changes in rules for the submission, assessment and conduct of clinical investigations with medical devices. Thus, the Central Committee on Research Involving Human Subjects (CCMO) has published a set of additional information under Research with medical devices from May 26, 2021.
CCMO has also made available some of the main changes as a result of the MDR. One of key changes reported is that a European portal, Eudamed, is under construction and is expected to be fully functional in 2022. In this portal, all relevant information concerning medical devices is registered, including the registration of clinical investigations. Clinical Trials conducted in the Netherlands are to be submitted on ToetsingOnline until Eudamed becomes functional. Also, the CCMO will be the competent authority for clinical investigations.
For more details on the above updates please refer to the post Research with a medical device from 26 May 2021 on the CCMO website.