Review by an accredited MREC
Other clinical research with medical devices that falls within the scope of the WMO must be reviewed by an accredited MREC based on the Medical Research Involving Human Subjects Act. An example of such research (i.e. research with medical devices that is subject to the Medical Research Involving Human Subjects Act that does not need to be reported to the Health Care And Youth Inspectorate) is a randomised study where two medical devices with a CE mark are compared to each other.
The accredited MREC that reviews the research file must have at its disposal adequate product information to be able to review the safety and quality of the medical device. The model Investigational Medical Device Dossier (IMDD, plus explanatory notes) can be used for this.
Existing product information is sufficient for medical devices with a CE marking. If a medical device with a CE marking is used for other purposes than those for which the CE marking was issued, then you must make clear how you propose to guarantee the safety and quality of the medical device. You can use the model Investigational Medical Device Dossier (IMDD, plus explanatory notes) for this. The accredited MREC will check if the information is sufficient for an adequate review and if not they will request additional information. The MREC can also decide to ask an external expert for advice.
A full overview of the documents which must be submitted to the MREC are given in the Standard research file. The procedure for the submission of a research file can be found under Primary submission to the reviewing committee.