Standard research file IVD performance studies

For the primary submission to an accredited MREC or CCMO, your research file must consist of a number of basic documents. These are listed below.

Some documents only need to be submitted if they are applicable. This partly depends on the legal frame under which your clinical investigation falls. This overview shows for each legal frame which documents you need to submit.

Additional documents

An accredited MREC may require additional documents not included in the standard research file. Please contact the relevant accredited MREC for more information.