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
Yes
National legal framework in place
Yes
