Glossary

Ethics committee [MDR/IVDR]

MDR IVDR

‘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.

 

[Definition under (EU) 2017/745 Article 2 No. 56 also corresponds to definition under (EU) 2017/746 Article 2 No. 59]