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
Yes
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
