Ethics committee

Under the MDR and IVDR, a clinical investigation or performance study cannot start against a negative ethics committee opinion in that member state. How committees are set up and work is a matter of national law, so procedures differ between countries.

‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;

EU MDR, Article 2(56)

‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;

IVDR, Article 2(59)

independent (3.26) body whose responsibility it is to review clinical investigations (3.8) in order to protect the rights, safety, and well-being of human subjects (3.50) participating in a clinical investigation Note 1 to entry: For the purposes of this document, “ethics committee” is synonymous with “research ethics committee”, “independent ethics committee” or “institutional review board.” The regulatory requirements pertaining to ethics committees or similar institutions vary by country or region.

ISO 14155:2020, clause 3.24