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 meerThe miss rates of corona antigen self-tests as reported in practice are quite shocking compared those reported in the self-test labelling. What causes those misses? What do we know based on data from clinical practice? I looked at 6 reasons (and a bonus reason) that may explain why self-tests miss a diagnosis, and checked the […]
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