Why the EU needed dedicated guidance on breakthrough devices
Recent experience has shown that, while MDR and IVDR are formally technology-neutral, their practical application has not always been conducive to the timely market entry of highly innovative medical technologies. This challenge has been particularly evident for devices addressing unmet medical needs, rare diseases, or life-threatening conditions, where conventional clinical evidence generation models may be difficult to apply.
MDCG 2025-9 responds to this gap by providing a common interpretative framework for competent authorities, notified bodies, and manufacturers across the European Union.
How MDCG defines a breakthrough device
The guidance adopts a functional rather than a formal definition of breakthrough devices. A breakthrough device is characterised by:
- a high degree of technological or clinical novelty,
- its potential to address an unmet medical need,
- the prospect of delivering a significant clinical benefit compared to the current state of the art.
Importantly, MDCG 2025-9 emphasises that breakthrough status does not arise from a manufacturer’s declaration but from a holistic assessment of the clinical context and technological characteristics of the device.
Breakthrough status does not mean simplified conformity assessment
A central message of MDCG 2025-9 is the explicit rejection of a “fast-track” or reduced regulatory scrutiny model comparable to those seen in other jurisdictions. Breakthrough devices remain fully subject to MDR and IVDR requirements, and the level of public health protection is not lowered.
The distinction lies in how existing regulatory tools are applied, not in the removal of regulatory obligations.
Flexibility in clinical and performance evidence generation
The guidance recognises that innovative technologies may require alternative approaches to evidence generation, provided that patient safety and scientific validity are preserved. MDCG 2025-9 supports greater flexibility where:
- risks are clearly identified and adequately managed,
- the evidence generation strategy is coherent and scientifically justified,
- post-market surveillance plays an active and central role.
In practice, this allows for increased acceptance of:
- adaptive clinical investigation designs,
- stepwise development of clinical and performance evidence,
- intensive PMS, PMCF, or PMPF activities as tools to confirm safety and clinical or diagnostic performance over time.
The role of notified bodies and expert panels
MDCG 2025-9 places strong emphasis on early and structured engagement with notified bodies in the case of breakthrough devices. Structured dialogue is highlighted as a key mechanism for:
- discussing the overall regulatory and clinical strategy,
- identifying critical risks and data gaps,
- aligning expectations regarding the scope and timing of evidence generation.
The guidance also underscores the importance of expert panels, particularly for high-risk breakthrough devices, where clinical assessment requires highly specialised expertise.
Transparency and conditional regulatory decisions
The guidance acknowledges that conformity assessment outcomes for breakthrough devices may be based on specific conditions, including:
- enhanced post-market surveillance obligations,
- mandatory post-market clinical or performance studies,
- additional reporting or follow-up requirements.
This approach enables earlier patient access to innovative technologies while maintaining continuous regulatory oversight of safety and performance.
Relevance for innovators and SMEs
MDCG 2025-9 is particularly relevant for small and medium-sized enterprises, which are often key drivers of breakthrough innovation but may face disproportionate regulatory challenges. The guidance:
- increases predictability of regulatory expectations,
- reduces the risk of divergent interpretations across Member States,
- reinforces dialogue-based regulatory engagement rather than purely formalistic review.
At the same time, it clearly states that innovation does not exempt manufacturers from robust risk management and high-quality evidence generation.
Relationship between MDCG 2025-9 and the proposed MDR/IVDR reform
The breakthrough device guidance should be read in close conjunction with the proposed MDR and IVDR reform. Both initiatives consistently promote:
- a risk-based regulatory approach,
- stronger reliance on post-market data,
- proportionality in regulatory requirements.
MDCG 2025-9 can therefore be seen as a practical bridge between the current legal framework and the more flexible regulatory model envisioned by the Commission.
Strategic conclusions
MDCG 2025-9 does not establish a new regulatory category or a dedicated breakthrough pathway. Instead, it creates a shared interpretative framework that enables a more rational and consistent application of MDR and IVDR to breakthrough technologies. Manufacturers that integrate this guidance into their regulatory and clinical development strategies at an early stage will be better positioned to navigate the evolving EU medical device regulatory landscape.