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EMA: Pilot Programme for Breakthrough Device

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The EMA plans to launch a pilot programme in Q2 2026 to implement the guidance for breakthrough devices issued in December 2025. 

The initiative aims to speed up access to highly innovative medical devices and IVDs while upholding safety and performance standards. BtX manufacturers will benefit from enhanced regulatory support and priority scientific advice from EMA expert panels. Detailed guidance for manufacturers will be published ahead of the pilot’s start. .

Source:

EMA: Human regulatory: overview - Medical devices

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