The European Commission (EC) issued a Q&A document  to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).

This document presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The issues covered by this document have been identified in the context of joint assessments, and the document may be updated from time to time as new issues are identified

MDCG 2019-6 Questions and answers: Requirements relating to notified bodies