Template Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) available
From September 15, 2023, the template Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) is available on the CCMO-website. The model is meant for IVD-performance studies applicable to article 58 of the EU regulation on in vitro diagnostic medical devices (IVDR).
The IMDD-IVD specifies the content of the technical documentation on IVDs in performance studies that you submit to the relevant review committee (accredited MREC or CCMO). 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.
Until January 1, 2024, the IMDD-IVD is optional with new submissions. After this date, CCMO strongly recommends the use the IMDD-IVD in new submissions.