D2. Investigational Medical Device Dossier (IMDD)
The Investigational Medical Device Dossier (IMDD) specifies the content of the documentation on non CE-marked medical devices in clinical investigations that you are required to submit to the review committee (accredited MREC or CCMO).
The requirements for information on a clinical investigation with a non CE-marked medical device that the sponsor needs to submit are laid down in Annex XV of the MDR. According to section 4.6 of Chapter II of Annex XV of the MDR, the review committee may request additional technical information.
Annex II of the MDR contains detailed requirements for the technical documentation that a manufacturer must prepare to demonstrate that the medical device meets the requirements of the MDR. To allow for a uniform submission of documentation for medical devices subject to clinical investigation, it was decided to use the technical documentation requirements specified in Annex II of the MDR as the basis for the IMDD.
If any part of the IMDD is addressed in another item or document submitted for the clinical investigation, e.g. the Investigator's Brochure (IB) or Technical Construction File, then a reference to that item or document is acceptable when a brief description of the information in that item or document with a reference is provided in the IMDD.
It is important that the IMDD contains sufficient information about the medical device for the review committee to be able to make a balanced judgement about the safety, performance and quality of the medical device for investigation.