The Medical Device Coordination Group published guidance on breakthrough devices (BtX) in December 2025 to accelerate access to highly innovative medical devices and in vitro diagnostics (IVDs) while maintaining rigorous safety and performance standards.
Under the framework, manufacturers of breakthrough devices can access enhanced regulatory support and priority scientific advice from the medical device expert panels that EMA administers.
To obtain breakthrough designation, manufacturers need to request an opinion from EMA’s expert panels.
EMA will publish detailed guidance for manufacturers before the pilot's launch.
More information:
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2 March 2026
Page first published; Content has been moved from another webpage as part of a broader content reorganisation