How to submit
All studies must be submitted in the Research Portal. How to submit your research file to the review committee depends on the legal framework your clinical investigation falls under. Below is an explanation of each legal framework.
Clinical investigations in the context of conformity purposes (MDR article 62/74.2)
For clinical investigations in the context of conformity purposes (MDR article 62/74.2) the research file is first validated by CCMO.
After a positive decision on the validation, CCMO will transfer your file to the review committee (accredited MREC or CCMO) for assessment. CCMO will transfer your file to the review committee of your preference.
Other clinical investigations (MDR article 82) or post-market clinical follow-up investigations (MDR article 74.1)
For other clinical investigations (MDR article 82) or post-market clinical follow-up investigations (MDR article 74.1), you may submit your file via the Research Portal. This submission is forwarded directly to the review committee you selected in the Research Portal.