B1a. Eudamed form

The Eudamed form is mandatory for performance studies falling under article 58 or 70 of the IVDR.

You are required to submit the Eudamed form while the Eudamed portal is not yet available. This also applies to any attachments if you are investigating several in vitro diagnostics and/or a comparative product.

CCMO will register the study based on these data in the current Eudamed database which is only accessible to EU Member States. The Eudamed registration number (CIV number) is  sent to the submitting party.

More information can be found on the page Clinical investigation: definition and framework.