PhaRegistrum · Originally published on 12/02/2026
The MDCG has recently published Guidance on Breakthrough Devices (BtX) under the MDR and IVDR, clarifying the framework for innovative devices, a classification that did not previously exist.
A device is considered breakthrough when expected to address unmet medical needs or have a significantly positive clinical impact on serious or life-threatening diseases.
The guidance clarifies designation criteria; preclinical, clinical and/or performance evidence; proportionate post-market surveillance; and manufacturer support.
BtX status does not grant market exclusivity and may apply to several devices with the same intended purpose.
PhaRegistrum helps manufacturers interpret and implement these frameworks.
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