On December 16, 2025, the European Commission published the new guidance MDCG 2025-9 on “Breakthrough Devices (BtX)”, with the aim of promoting and facilitating the entry into the European market of highly innovative medical devices and in vitro diagnostic devices intended for the treatment of serious diseases or health conditions—while maintaining strict standards for safety and clinical evidence.

This initiative represents an important step toward making advanced medical technologies more accessible to patients, while optimizing complex regulatory pathways that could otherwise make these products marginal or difficult to access.

The practical implementation of the guidance will take place through a pilot project scheduled to start in Q2 2026 (April–June 2026).

What qualifies as a BtX? Selection criteria

Not all innovative devices can qualify as Breakthrough Devices. To fall under this guidance, a medical device or in vitro diagnostic device must meet all of the following criteria:

Novelty
The device must introduce a high degree of innovation in terms of technology and related clinical procedures. It should represent a technological or clinical leap compared with the state of the art (e.g., new mechanisms of action, revolutionary materials, or advanced AI algorithms).

Significant clinical impact
The device is expected to deliver a positive clinical impact on patients or public health, through one of the following:

• Clearly outperforming current therapies and the state of the art,
  OR

• Addressing an unmet medical need due to the absence or ineffectiveness of existing therapeutic options.

Critical target condition
The device must be intended for potentially life-threatening or irreversibly debilitating diseases or conditions.

Data Rebalancing

The core concept of MDCG 2025-9 is “Data Rebalancing.” This approach recognizes that for radically new technologies, collecting complete pre-market clinical evidence may sometimes be ethically or technically difficult.

The key principle is that the guidance allows the possibility of certifying a device while accepting a certain level of “residual clinical uncertainty” at the time of market placement, provided this is balanced by very rigorous post-market surveillance.

Companies must therefore be prepared to manage:

• Structured PMCF/PMPF plans: continuous and proactive clinical monitoring to confirm initial benefits.

• Real-World Evidence (RWE): the use of data from everyday clinical practice and national registries to support device performance.

Procedural pathway and scientific support

The BtX pathway is not a regulatory shortcut, but rather a process based on intensive scientific dialogue. The guidance provides for:

• Involvement of Expert Panels: for high-risk devices, EU expert support becomes essential to validate the “Breakthrough” nature of the product during conformity assessment.

• Early dialogue with Notified Bodies: proactive discussion on clinical strategy is encouraged to avoid delays during the final stages of certification.

• Pilot Project (Q2 2026): practical implementation will begin with a trial phase aimed at refining evaluation criteria before full system deployment.

The BtX framework may represent a pathway of excellence, marking an important step toward a system that supports responsible innovation, accelerates patient access to life-saving technologies, and simultaneously ensures a high level of public health protection.

For full details, see the guidance.

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Source:

MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746