CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
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
MD CE- marked, use within label (+IMP) with extra burden and invasive examination for the patients
CA - Submission required to
National CA
CE-marked MD used within label are exempted from any notification obligation to CA
Yes
Additional Information
Clinical investigations of CE-marked MD used within label are exempt from authorisation requirement
Submission to CA and EC to be performed in the following order
In parallel
Sequentially (in any order)
