Breakthrough device (BtX)

MDCG 2025-9 sets out criteria and possible support for such devices, for example early dialogue with expert panels. It is separate from the FDA Breakthrough Devices Program, which has its own criteria and process.

In certain circumstances, a medical device (MD) or in vitro diagnostic medical device (IVD) may be described as a breakthrough device (BtX) when it represents an innovation that is expected, based on available information, to offer a novel diagnostic or therapeutic option addressing an unmet medical need for a particular patient population with serious and life-threatening diseases or conditions when compared with state of the art.

MDCG 2025-9, Section 2, Introduction