In the second quarter of 2026, the EMA plans to launch a pilot for breakthrough #medicaldevices and #invitrodiagnostics with the goal to test a pathway that accelerates patient access to highly innovative technologies, while guarding #safety and #performance standards. This pilot further builds on the recently adopted guidance MDCG 2025-9: For all devices, clinical evidence must […]
Lees meerDecember 16 the General Directorate for Health and Food Safety issued a proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. With some very interesting elements in there, the proposal for example includes a suggestion for a wider range of data that may qualify as clinical data with, under Article […]
Lees meerUnder MDR Adverse Event reporting is meant to be more straightforward and uniform accross the different EU memberstates, but is that truely the case? One of the topics as discussed during the medical device joined ClinOps and RegNed springmeeting of the NVFG April 2023. Below you find the concerning presentation. Feel free to reach out […]
Lees meerHow do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR) applies in May 2021? Can you continue to do what you did under MDD and are you then OK? A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a […]
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