A relevant development for the medtech industry: today, 28 April 2026, the EMA has launched its pilot programme to support developers of Breakthrough Devices (BtX) under the MDR and IVDR.The pilot builds on the MDCG guidance published in December 2025, which established the Breakthrough Device designation for innovations offering a novel diagnostic or therapeutic option for serious, life-threatening or irreversibly debilitating conditions, where there is an unmet medical need.
To qualify for BtX designation, devices must meet two cumulative criteria:
- A high degree of novelty
- A significant positive clinical impact
For manufacturers, this framework may provide important advantages, including:
- Priority scientific advice from EMA Expert Panels
- Earlier and more structured interaction with Notified Bodies
- Greater flexibility in clinical evidence, combined with robust post-market data collection
- Specific support for SMEs
More information on the EMA pilot and how to apply is available here:
https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-breakthrough-medical-devices-pilot-programme
MDCG guidance (December 2025):
https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdf
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