ECGeneralEthicalReview object
Submission for Ethical review mandatory for
Observational MD investigations
MD CE-marked, use within label
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
Submission to CA and EC to be performed in the following order
EC first
Additional Information
No parallel request for authorisation possible: there is a need of an EC opinion before submission to the CA
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)/ For certain types of MDs
Ethics committee(s)
