CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
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
CA - Submission required to
National CA
CE-marked MD used within label are exempted from any notification obligation to CA
Yes
Additional Information
A notification must sent to the national competent authority (NCA) in all EEA/EU states where the investigation is going to take place.
Clinical investigations of CE marked devices utilised for their intended purpose do only require notification to EC!
For national registration, contact the responsible Health Trust.
Registration at clinicaltrials.gov may be a requirement for publication in certain journals.
