MDCG 2025-9 Guidance on Breakthrough Devices (BtX)

The MDCG 2025-9 Guidance outlines the regulatory framework for breakthrough devices (BtX) under the European Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). Its main goal is to enable timely patient access to innovative devices that address serious, life-threatening, or irreversibly debilitating conditions, without compromising the clinical evidence requirements for these devices. The guidance applies to all technologies and risk classes, except for custom-made devices, in-house devices, and products without a medical purpose.

Criteria for Breakthrough Device Designation

A device qualifies as a breakthrough device if it

• introduces a high degree of novelty in technology, clinical procedure, or application, and either of the following:
• is expected to have a significant positive clinical impact on patient or public health, or
• addresses an unmet medical need, either by providing a solution where no adequate alternatives exist or by offering a substantial improvement over current options.

Manufacturers must demonstrate how their device meets these criteria, considering the current state of the art and available alternatives. The breakthrough designation of the BtX remains unaffected by the introduction of another medical device or IVD with the same intended purpose to the market.

Clinical and Performance Evaluation

Manufacturers are required to conduct clinical evaluations (for medical devices) or performance evaluations (for IVDs) to demonstrate compliance with the MDR or IVDR. The guidance supports a balanced approach, allowing for some uncertainty regarding safety or performance at the time of market access, provided there are robust plans for post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF). These plans are essential for collecting confirmatory data and ensuring patient safety.

Manufacturers should:

• Provide clear justification for any data collected post-market rather than pre-market
• Develop comprehensive PMCF/PMPF plans, including milestones and timelines
• Use real-world data and registries where appropriate to supplement evidence

Risk Management and Technical Documentation

Risk management is a central element in the development of breakthrough devices. Manufacturers must document risk management strategies early, detailing how risks - especially those arising from innovative features - are identified and mitigated. The risk management process must be closely linked to the clinical evaluation, with residual risks weighed against the anticipated benefits. Technical documentation must include a comprehensive clinical evaluation plan (CEP), pre-clinical testing, usability studies, and manufacturing validation. For IVDs, as usual, the initial performance evaluation must already cover analytical performance, scientific validity, and clinical performance.

Role of Notified Bodies and Expert Panels

Notified bodies play a crucial role in the assessment and certification of breakthrough devices. They are expected to prioritize BtX files, support manufacturers in evidence generation, and may issue certificates with specific conditions, such as enhanced PMCF requirements. Manufacturers, especially those of high-risk devices, are encouraged to seek early scientific advice from expert panels. The advice and its consideration must be documented in the clinical evaluation report. Early engagement can help optimize clinical development strategies and reduce regulatory uncertainty.

Within the BtX framework, expert panels may

• Provide an opinion on the BtX status designation,
• Provide early scientific advice,
• Provide early pre-clinical or clinical advice in line with Article 106 MDR,
• Conduct consultation under the Clinical Evaluation Consultation Procedure.

Transparency and User Information

Manufacturers must ensure that the breakthrough status of the device is clearly communicated in all relevant documentation, including labeling, instructions for use (IFU), and the Summary of Safety and Clinical Performance (SSCP). Instructions on how to report incidents, complaints, and clinical experiences must be included. Transparency is further supported by a planned public dashboard for BtX designations and certifications.

Special Considerations and Support

The guidance addresses special considerations for small and medium enterprises (SMEs), and funding opportunities through EU and national programs. Notified bodies should provide support and structured dialogue mechanisms and establish procedures to facilitate the conformity assessment of breakthrough devices in a transparent and timely manner that is cost-effective and proportionate to the interests of SMEs.

Various EU and national funding mechanisms are available to support innovation in breakthrough devices. European funding includes the following programs: EU4Health Programme, European Innovation Council (EIC) Accelerator, Horizon Europe health clusters, Innovative Health Initiative (IHI), Invest EU Programme, and Enterprise Europe Network (EEN).

Certification and Post-Market Surveillance

Notified bodies may issue certificates with specific conditions for BtX devices, such as

• defined PMCF activities, e.g., PMCF studies within a specified period of time,
• enhanced surveillance and monitoring, including periodic milestone reporting on safety and performance,
• informing users and patients on the BtX status of the device, the supporting clinical evidence and instructions for reporting incidents, complaints, and clinical experience to the manufacturer,
• information of EMA/MDCG about market access.

Manufacturers must ensure compliance with these conditions and maintain a comprehensive post-market surveillance system to monitor safety and performance throughout the device’s lifecycle. Regular updates to the clinical evaluation report are required as soon as new information affecting the benefit-risk profile is available, and notified bodies should re-assess clinical evaluation reports at increased frequencies, proportionate to the level of clinical risk.

Conclusion

The MDCG 2025-9 Guidance offers a supportive regulatory environment – guidance, adapted procedures, support, funding – for breakthrough devices, balancing the need for innovation with patient safety. Manufacturers should focus on demonstrating novelty and clinical benefit, implementing robust risk management and post-market strategies, and maintaining transparency throughout the device lifecycle. Early and structured engagement with notified bodies and expert panels is strongly recommended to facilitate successful market access and ongoing compliance.