Before revision: Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices (IVDR).IVDR - 2017/746 The MDCG Guideline 2023-3 "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices" provides furter clarification on the topic.
After revision: Similar provisions on Post-Market Surveillance are found in the European regulation on in vitro diagnostic medical devices (IVDR).IVDR - 2017/746 The MDCG Guideline 2023-3 "Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices" provides further clarification on the topic.