CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)
Agency for data protection

CA - Submission for authorisation mandatory for

MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP

CE-marked MD used within label are exempted from any notification obligation to CA


Additional Information

Clinical investigations of CE marked devices utilised for their intended purpose do require notification to EC only!

NB! Combination studies: If the investigation includes an evaluation of medicinal products, the clinical investigation may be classified as a clinical trial of medicinal products and require authorisation by the DHMA unit for clinical trials

Submission to CA and EC to be performed in the following order

In parallel