Primary submission investigations with clinical devices

Clinical investigations with medical devices must be assessed in advance by an authorised review committee, as stipulated in the EU Medical Device Regulation (MDR) and/or the Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen, WMO]. On What is assessed by whom you can find which research files may be assessed by an authorised review committee.

For the primary submission to an accredited MREC or CCMO you need to submit a number of documents. These documents can be found in the Standard research file medical devices. Information on how to submit the research file and which assessment periods apply can be found at How to submit and Assessment periods.

In addition, research files for conformity purposes need to be validated by CCMO before they can be assessed. Information on validation can be found at Validation by CCMO of clinical investigations for conformity purposes.