D2. Investigational In Vitro Medical Device Dossier (IMDD-IVD

The requirements for information on a performance study with a non CE-marked IVD that the sponsor needs to submit are laid down in Annex XIII and XIV of the MDR. According to section 4.6 of Chapter I of Annex XIV of the IVDR, the review committee may request additional technical information.

Annex II of the IVDR 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 IVDs for performance studies, it was decided to use the technical documentation requirements specified in Annex II of the IVDR as the basis for the IMDD-IVD. This IMDD-IVD guidance document provides additional guidance on the interpretation of some parts and provides information on the required documentation to be submitted, see paragraphs 1-6.

If any part of the IMDD-IVD is addressed in another item or document submitted for the performance study, 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-IVD.

It is important that the IMDD-IVD contains sufficient information about the IVD for the review committee to be able to make a balanced judgement about the safety, performance and quality of the IVD for performance study