Primary submission IVD performance studies
Specific IVD performance studies must be assessed in advance by an authorised review committee, as stipulated in the IVDR 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 in vitro diagnostics. Information on how to submit the research file and which assessment periods apply can be found at How to submit and Assessment time limits.
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 CCMO validation of IVD performance studies. The validation is not mandatory for a post-market performance follow-up study (PMPF study).