B1a. Eudamed form

The Eudamed form is mandatory for clinical investigations falling under article 62 or 74 of the MDR.

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 more than one medical device and/or 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) isĀ  mentioned in the positive validation message.

This form is not needed for clinical investigations that fall under Article 82 of the MDR. More information can be found on the page Clinical investigation: definition and framework.