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

Observational MD investigations
MD CE-marked, use within label + IMP
MD CE-marked, use outside label
MD CE-marked, use outside label + IMP
MD without label
MD without label + IMP

CA - Submission required to

National CA

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


National legal framework in place


Applicable national legal framework/ Reference

Art 21 Regulation no. 934/2010