Standard research file medical devices
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. An overview showing which documents to submit for each legal frame is available.
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.