D2. Investigational Medical Device Dossier (IMDD)
The Investigational Medical Device Dossier (IMDD) specifies all items that must be covered for the application to the review committee (accredited MREC or CCMO) for non-CE-marked medical devices intended for clinical investigation.
It is important that the IMDD contains enough information about the medical device so the review committee can judge the safety, performance and quality of the medical device for investigation.
Annex II (technical documentation) of the EU Medical Device Regulation (EU nr 2017/745) is used in the IMDD as basis for the requested documentation.
In the IMDD template you can find information about the data that must be provided. Please contact the review committee for remaining questions about the requested documentation.