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 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 […]
Lees meer