EU Guidance on Breakthrough Devices guidance issued by MDCG

The EU Medical Device Coordination Group (MDCG) has now published its long-awaited ‘Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746‘, MDCG 2025-9.

The document explains that “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.”

While the MDR and IVDR lack specific provisions for the treatment of BtX devices, the guidance presents “recommendations for facilitating a streramlined pathway for CE marking . . . to allow for timely patient access without compromising the clinical evidence requirements.”

The document specifies the criteria for a device to be considered a BtX if it meets each of the following criteria:

1. Novelty
The device introduces a high degree of novelty with respect to the device technology, the related clinical procedure, and/or the application of the device in clinical practice,
AND
2. Positive clinical impact
The device is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following:
– Offering a significant positive clinical impact on patients or public health compared to available alternatives and the state of the art, OR
– Fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.

The route to achieving BtX status involves requesting an opinion from one of the ‘expert panels’ set up to provide scientific advice under MDR Article 106. A BtX, once designated, can receive certain support and benefits to aid device development. This includes Notified Bodies:

• Prioritising BtX submissions during planning and resource allocation,
• Engaging in early and structured dialogue with BtX manufacturers, especially regarding the generation of clinical evidence, and
• Coordinating with expert panels to ensure coherence between the scientific advice and the conformity assessment process.

Copies of the full 36 page guidance can be obtained from here.