The Medical Device Coordination Group (MDCG) has published a new guidance document MDCG 2023-3 entitled “Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices.” You can find it on the European Commission’s health website. It sheds some more light on the requirements of the vigilance system that medical device manufacturers must implement in order to comply with Medical Device Regulation (EU) 2017/745. The intention of the document is to clarify important terms and concepts of Chapter VII of the MDR “POST-MARKET SURVEILLANCE, VIGILANCE, AND MARKET SURVEILLANCE,” Section 2 “VIGILANCE.” It should serve to create a common understanding of these terms and concepts, to enable effective and harmonized implementation of the vigilance requirements of the MDR.
SGS Germany GmbH offers MDR certification for the medical products provided by SGS Fimko Oy (CE0598) within a wide scope of notification: SGS Fimko Oy Notification Scope
Visit our website to find information about the timeline, application requirements, and prices: CE Marking of Medical Devices (sgs-cqe.de).
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