Breakthrough Devices (BtX): what does MDCG 2025-9 really change for medical device manufacturers?

Innovation is at the heart of many medical device projects. Yet, under MDR and IVDR, many manufacturers are making the same observation: the more innovative a device is, the more uncertain its regulatory path becomes. Clinical requirements are difficult to anticipate, expectations vary from one player to another, and there are constant comparisons with accelerated access programs outside the EU.

The publication of MDCG 2025-9 - Guidance on Breakthrough Devices (BtX), on December 16, is clearly part of this context. The document does not create a new regulatory status, but proposes a common framework for identifying and supporting breakthrough devices, while remaining aligned with MDR and IVDR requirements.

The challenge is twofold: to facilitate market access for certain major innovations, without weakening the expected level of safety and performance requirements.

What is a "Breakthrough Device" according to MDCG 2025-9?

The guide introduces the term Breakthrough Device (BtX) as a cross-cutting concept, covering both :

• medical devices (BtMD) covered by the MDR,
• in vitro diagnostic medical devices (BtIVD) under IVDR.

One point is clear from the outset: breakthrough does not mean "priority by default", nor "marketing innovation". These are devices whose breakthrough is sufficiently marked to justify a proportionate regulatory approach, particularly with regard to clinical strategy.

The scope is deliberately broad: all technologies and all risk classes can be concerned. However, custom-made devices, devices manufactured in-house by healthcare establishments and Annex XVI products are excluded.

What criteria must a device meet to qualify as a Breakthrough Device?

The MDCG is very clear: the criteria are cumulative. A device must meet both a high novelty requirement and an expectation of significant positive clinical impact.

The novelty criterion: a real breakthrough, not an incremental improvement

Novelty may relate to several aspects :

• the technology itself (materials, mechanism of action, AI, nanotechnologies, biomarkers, analytical platforms),
• the associated clinical procedure,
• the application of the device in clinical practice (new indication, new patient pathway, new user, deployment outside the laboratory, automation, etc.).

The guide stresses a point often misunderstood by manufacturers: an incremental improvement to an existing device, however effective, is generally not enough. The smaller the breakthrough, the more difficult it becomes to justify BtX status.

Conversely, devices that are "first-in-class" or likely to bring about a clinical paradigm shift are explicitly cited as good potential candidates.

The criterion of significant positive clinical impact

Novelty alone is not enough. The device must target :

• a serious, life-threatening or irreversibly debilitating disease,
• and demonstrate a significant expected clinical benefit compared with the state of the art, or meet an unmet medical need.

The evaluation is comparative in nature: performance, clinical benefits, risks, quality of life, public health impact.

The guide underlines a central tension: the greater the novelty, the greater the uncertainty, and the more the manufacturer must be able to credibly justify the expected benefit.

Does Breakthrough Device status change MDR / IVDR clinical requirements?

The short answer is often counter-intuitive: yes in approach, no in level of requirement.

The guide does not create any regulatory exemptions. MDR and IVDR requirements remain fully applicable. On the other hand, it explicitly recognizes that, for certain breakthrough devices :

• full generation of pre-market clinical data may be unrealistic,
• certain conventional designs (e.g. randomized RCTs) may be difficult to apply, or even unethical.

The proposed logic is based on a rebalancing between pre-market and post-market data:

• a sufficiently robust base of clinical or performance data to demonstrate safety and expected benefit,
• supplemented by a reinforced PMS and PMCF / PMPF, designed right from the start of development.

In other words, BtX is not a shortcut. It's a clinical strategy that's more demanding in its coherence, but sometimes more realistic in its sequencing.

What role do expert panels and notified bodies play in BtX?

The role of expert panels

MDCG 2025-9 clearly reinforces the role of expert panels in supporting breakthrough devices:

• advice on Breakthrough Device status,
• possibility ofearly advice at a very early stage of development,
• possible coordination with health technology assessment authorities (HTA).

This approach is in line with existing mechanisms, notably the Clinical Evaluation Consultation Procedure (CECP).

The role of notified bodies

As far as notified bodies are concerned, the guide provides for :

• prioritization of BtX dossiers,
• enhanced structured dialogue,
• the possibility of certificates with specific conditions,
• particular attention to post-market surveillance.

The message is clear: BtX does not reduce the role of the notified body, but moves it further upstream and throughout the life cycle.

Case studies: what the guide means in concrete terms for manufacturers

Case study 1 - Highly innovative device, limited clinical data

A manufacturer is developing a radically new device for a serious pathology, with few or no clinical equivalents. Pre-market data are promising but still limited.

Without a BtX framework, this type of project often comes up against clinical requirements that are difficult to meet before CE marking. In this case, the guide enables us to defend a structured approach: solid scientific justification, early collection of relevant data, and a clearly asserted reinforced PMCF.

Case study 2 - A high-performance device with little differentiating power

On the other hand, a device may boast excellent technical performance while remaining close to the state of the art. In this case, the guide is explicit: BtX status is difficult to justify.

The message is deliberately dissuasive with regard to attempts at overqualification. BtX is about breakthrough, not optimization.

Breakthrough Device: strategic opportunity or regulatory false hope?

MDCG 2025-9 does not promise an automatic fast-track to CE marking. It offers neither market exclusivity nor regulatory relief by default.

On the other hand, it does provide something more subtle but fundamental:

• official recognition of the uncertainty associated with disruptive innovation,
• a common framework for discussing proportionality,
• a lever for structured dialogue with authorities and notified bodies.

For manufacturers, BtX status is above all a strategic tool, to be prepared well in advance of the CE dossier, well before formal submission.

Mini FAQ - Breakthrough Devices (BtX)

Can a device be BtX if an alternative already exists on the market?

Yes, as long as it demonstrates a significant clinical benefit compared to the state of the art.

Does BtX status make it possible to avoid clinical investigation?

No. BtX status can be used to adapt clinical strategy, but not to eliminate requirements.

Is BtX status definitive?

No. It may evolve over time, depending on the development of the device and the clinical context.

Are medical software and AI devices concerned?

Yes, they are explicitly mentioned in the guide.

Can BtX and orphan devices be combined?

Yes, the two frameworks are considered complementary.

Related resources

• CECP procedure: what should medical device manufacturers be aware of?
• Publication of clinical investigation reports: MDCG 2024-15 explained
• Understanding the importance of risk management plans (RMPs) for medical devices

The Breakthrough Device approach reminds us of an obvious fact that is sometimes forgotten: regulatory innovation is not about circumventing requirements, but about structuring them intelligently when conventional frameworks reach their limits. It requires upstream thinking on clinical strategy, risk management, data sequencing and dialogue with the authorities, well before the CE mark dossier is submitted.

In this context, CSDmed provides its customers - start-ups, manufacturers, importers and distributors of medical devices - with regulatory expertise and a methodical approach, supported by a team of specialized consultants. This approach enables R&D, quality management system (QMS) and MDR / IVDR technical file issues to be addressed in a coherent and integrated way, taking into account the specific features of innovative devices.

🔗 Contact us to find out how we can help you structure and secure your project.