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The European Commission has released the second revision of the MDCG 2023-3 guidance document in January 2025. This update includes important clarifications in line with Regulation (EU) 2024/1860, affecting the implementation of Eudamed, post-market surveillance, and reporting timelines. Below, we summarize the key changes:
The European Commission has issued the revised MDCG 2022-4 guidance, focusing on appropriate surveillance during the transition from the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to the Medical Device Regulation (MDR).
We're pleased to provide you with important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607. As the landscape of medical device regulations continues to evolve, it's crucial for stakeholders to remain informed and compliant.