지침,참고문헌 | MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies

MDCG 2019-6 v2 QA requirements for notified bodies V2 01102019.pdf (130.6K) [30]

Introduction
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.