CATrialAuthorisation object
Regulatory and ethics bodies involved in approval process
Competent Authority/-ies (CA)
Ethics committee(s)
CA - Submission for authorisation mandatory for
Active Implantable Medical Devices (AIMD)
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
MD Class III
Other high-risk devices (Class IIa or IIb implantable and long-term invasive MDs)
CA - Registration/ notification without approval required for
Performance evaluations of in-vitro diagnostic MDs
MD Class I
CE-marked MD used within label are exempted from any notification obligation to CA
Yes
National trial registry - Registration mandatory
No registry in place
Additional Information
A detailed guidance on notification obligations is available on the BASG website for download in English and German: L I102 Overview about Notification Procedures (en)/ L I64 Meldeverfahren (de)
