Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics
Medical Devices, In Vitro Diagnostics, Patient Access Elisabethann Wright Medical Devices, In Vitro Diagnostics, Patient Access Elisabethann Wright

Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics

‍In the second quarter of 2026, the European Medicines Agency (EMA) will launch a pilot programme to support breakthrough medical devices and in vitro diagnostic devices. The purpose of the programme will be to test a pathway that is intended to accelerate patient access to highly innovative technologies, while maintaining the EU’s high standards for safety and performance. Manufacturers participating in the pilot will benefit from

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Update of European Commission PMSV reporting forms page
Manufacturer's Incident Report, Medical Devices, In Vitro Diagnostics Elisabethann Wright Manufacturer's Incident Report, Medical Devices, In Vitro Diagnostics Elisabethann Wright

Update of European Commission PMSV reporting forms page

The European Commission has updated its PMSV reporting forms page to reflect the new version (7.3.1) of the Manufacturer Incident Report (MIR form) that was published in December 2025.

As part of the update the European Commission took the opportunity a

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