How to submit
All studies must be submitted in the Research Portal. How to submit your research file to the review committee depends on the legal frame that applies to your performance study. Below is an explanation per legal framework.
Performance studies (IVDR article 58/70(2))
For IVD performance studies (IVDR article 58/70(2)), first of all the research file is validated by CCMO. After a positive validation, CCMO will transfer your file to the review committee (accredited MREC or CCMO), taking into account any preference for an accredited MREC. You can indicate this preference in the cover letter of the file and select the MREC in the Research Portal.
Post-market performance follow-up (IVDR article 70(1))
Post-market performance follow-up studies with additional invasive and burdensome procedures (PMPF, IVDR article 70(1)), are put through directly to the review committee.
Notification companion diagnostic performance studies with leftover samples only
For performance studies with companion diagnostics a specific provision has been included in the IVDR (IVDR article 58(2)). This means that these performance studies must be reviewed by an accredited review committee. An exception applies if only leftover samples are used; in that case a notification to the CCMO at devices@ccmo.nl is sufficient.