Medical device manufacturers doing business in the European Union (EU) will want to review the most recent version of the MDCG 2019-6 Questions and Answers (Q&A) document, which represents the most significant update to date, with five updated Q&As, two replacement Q&As, and one new Q&A.
Of particular interest in this update, Question I.6 (Q I.6) concerns whether notified bodies would be able to provide pre-certification services, has been expanded into three parts and Q I.6.3 discusses structured dialogues. In addition, Q IV.13 on “leveraging evidence” has been added.
EU Revises Guidance on Notified Bodies: Structured Dialogues and Leveraging Evidence | Emergo by UL
EU Revises Guidance on Notified Bodies: Structured Dialogues and Leveraging Evidence
Medical device manufacturers doing business in the European Union (EU) will want to review the most recent version of the MDCG 2019-6 Questions and Answers (Q&A) document, which represents the most significant update to date regarding notified bodies.
www.emergobyul.com