ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
All local ECs of participating sites
Submission of application required to
All local ECs of participating sites
Additional Information
A 'single opinion' or mutual recognition is not established for studies with medical devices. However, any local EC can accept the opinion provided from another EC in Austria. In this case, the EC assessing the clinical investigation or performance evaluation must be provided with information regarding all additional investigators and with any documentation allowing the professional qualification and experience of the investigators, the available facilities, and the qualification of the supporting staff to be assessed (MPG § 57 (2))
