The Medical Device Coordination Group (MDCG) has published guidance MDCG 2025-91 to streamline the pathway for breakthrough devices (BtX) under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This guidance aims to facilitate timely patient access to innovative technologies without compromising safety and performance requirements. It provides detailed recommendations on designation criteria, regulatory benefits, clinical evidence strategies, and post-market obligations. The document also clarifies roles of expert panels, notified bodies, and funding opportunities for manufacturers.
A breakthrough device (BtX) refers to a medical device (MD) or in vitro diagnostic device (IVD) that offers a novel diagnostic or therapeutic option for serious or life-threatening conditions compared to the current state of the art. These devices address unmet medical needs and represent significant innovation in technology, design, or clinical application. Importantly, BtX designation does not confer market exclusivity; multiple devices can share this status if they meet the criteria.
To qualify as a BtX, a device must meet two key criteria:
Manufacturers are required to describe the current state of the art and justify how the device improves health outcomes compared to alternatives supported by scientific literature, pre-clinical data, and preliminary clinical evidence.
BtX designation can be granted early in development, even years before market access. Multiple devices may share BtX status, which does not confer exclusivity. Benefits include:
Expert panels, established under MDR Article 106, play a critical role in the breakthrough device pathway. Manufacturers seeking BtX designation must apply to these panels for an official opinion on whether their device meets the breakthrough criteria. Beyond designation, expert panels provide scientific and clinical advice at various stages of development, including early guidance on clinical strategies and evidence-generation plans. Engagement with expert panels early can help reduce regulatory uncertainty, optimize study design, and accelerate conformity assessment—particularly for high-risk devices and those addressing unmet medical needs.
A balanced approach is recommended: sufficient pre-market data to demonstrate safety and performance, complemented by confirmatory post-market data through PMCF/PMPF. Manufacturers must implement robust risk management strategies, linking risk evaluation to clinical evidence generation. For AI-based devices, compliance with the AI Act and bias mitigation in datasets is essential. For IVDs, analytical performance and scientific validity must be rigorously demonstrated.
Manufacturers must clearly communicate BtX status in labeling, SSCP/SSP, and EUDAMED. The guidance emphasizes increased transparency around BtX devices, with further transparency mechanisms expected to evolve. Post-market surveillance and PMCF/PMPF activities are critical to confirm safety and performance throughout the device lifecycle.
The guidance highlights EU and national funding programs to support innovation, including EU4Health, Horizon Europe, EIC Accelerator, and InvestEU. These mechanisms are complementary to BtX designation; they are not embedded within the designation process. Manufacturers may explore these opportunities to reduce financial barriers and foster development of breakthrough technologies.
The new MDCG 2025-9 guidance is a welcome step for both medical devices and IVDs. It brings helpful clarity on what counts as a breakthrough device, how evidence can be built over time, and how expert panels and notified bodies are involved. The definitions and criteria presented for “novel technology” and expected clinical outcomes closely reflect concepts already used in earlier EU guidance—such as CECP interpretation guidance2—strengthening consistency across regulatory processes. Europe now has a framework that resembles the FDA’s Breakthrough Device Program, although the two systems operate differently and should not be viewed as equivalent.
However, practical implementation raises some concerns. The guidance is quite focused on regulatory qualification and there is less detail on how breakthrough technologies fit into everyday clinical work. Some concrete examples of real clinical impact, like changes in diagnostic pathways, treatment decisions, or patient management, would make this easier to understand in practice.
The role of the expert panels is clear, but early discussions may be still limited by expert panel capacity and the structured nature of current consultation processes. Easier access to EU-level scientific advice could improve predictability, especially for smaller companies.
It’s also worth mentioning that breakthrough innovation doesn’t have to mean completely new technology. Sometimes real progress comes from modest meaningful improvements, like better test accuracy or clearer support for clinical decisions. More detailed guidance on how such improvements are considered would strengthen the BtX framework.
Finally, while transparency and post-market evidence are emphasized, it remains to be seen what acceptable uncertainty at market entry and practical PMCF/PMPF expectations are in real life.
Overall, MDCG 2025-9 is a solid step forward. The industry would, however, benefit from clearly defined practical use examples and easier engagement with experts/expert panels.
MDCG 2025-9 represents a significant step toward enabling innovation while safeguarding patient safety. Manufacturers planning to apply for BtX designation benefit from creating solid evidence strategies and utilizing the regulatory support available.
At Aurevia, our experts can help you navigate these processes and ensure compliance with MDR and IVDR requirements. Contact us to learn more.