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
MD CE- marked, use within label (+IMP) with extra burden and invasive examination for the patients

CA - Registration/ notification without approval required for

Observational MD investigations
MD Registry

National trial registry

It is mandatory to register clinical studies in a registry.
An official national register for clinical studies is available: Deutsches Register Klinischer Studien (DRKS)

National legal framework in place

Yes

Applicable national legal framework/ Reference

Art 20-23b MPG

Additional Information

NB! Section 23b MPG contains an important exception:
“Absehen von der Genehmigungspflicht” (waiving the authorisation) is possible for class I and non-invasive class IIa medical devices and MD with low safety risk.
The provisions contained in §§ 20-23a shall not apply where the clinical investigation is conducted using devices which are authorised in accordance with §§ 6 and 10 to bear the CE marking, unless the aim of the investigation is to use the device for a different intended purpose or additional invasive or other stressful examinations are to be carried out.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395