The publication of MDCG 2025-9 marks a significant development in the European regulatory landscape for medical devices and in vitro diagnostic devices. The guidance introduces a structured framework for qualifying, assessing and certifying breakthrough medical devices and IVDs under the MDR and IVDR. It clarifies how innovation that delivers meaningful clinical impact should be evaluated while maintaining high levels of patient safety and scientific rigour. The guidance does not apply to custom-made devices, in-house devices or products listed in Annex XVI without an intended medical purpose. Instead, it focuses specifically on devices that demonstrate both a high degree of novelty and a significant positive clinical impact.
What Qualifies as a Breakthrough Device
Under MDCG 2025-9, a medical device or IVD qualifies as a breakthrough device only if it meets two cumulative criteria. First, it must demonstrate a high degree of novelty. Second, it must be expected to provide a significant positive clinical impact for patients or public health in the context of serious, life threatening or irreversibly debilitating conditions. Both criteria must be satisfied. Novelty alone is insufficient, and incremental improvements without meaningful clinical impact will not qualify.
Understanding Novelty Under the Guidance
Novelty under the breakthrough framework refers to characteristics that do not have an established history of use within the current state of the art. A high degree of novelty is required, meaning that the innovation must be substantial rather than incremental. Novelty can relate to the device technology itself, the associated clinical procedure or the application of the device in clinical practice.
With respect to device technology, novelty may involve new materials with different chemical, physical or biological properties, altered duration of tissue contact, modified release characteristics of substances, innovative design specifications or a new mechanism of action. In the IVD context, novelty may include use of a different sample type or novel analytical methods. Portability, integration of medical device artificial intelligence, nanotechnology, advanced materials or precision medicine applications may also contribute to a finding of novelty.
Novelty may also arise from changes to intended purpose, new clinical indications, different user groups such as lay users or application of existing technologies in new contexts such as early detection, screening or predictive monitoring. However, novelty must be demonstrably significant and not simply a routine evolution of established practice.
Defining Significant Positive Clinical Impact
In addition to novelty, a device must provide a significant positive clinical impact compared to available alternatives and the state of the art, or it must address an unmet medical need where alternatives are absent or insufficient. The assessment of impact occurs at both the individual patient level and the population level.
At the individual level, considerations include whether the device improves diagnosis, treatment, management or prevention of serious conditions. Clinical outcome improvements may include reduced mortality or morbidity, enhanced quality of life, reduced treatment burden, shorter hospital stays or fewer re-interventions. Mode of care delivery is also relevant, such as easier administration or procedural efficiency. Risks and harms must be assessed in parallel, including device related adverse events, compatibility issues and risks associated with vulnerable patient groups. The overall benefit-to-risk balance determines whether the net impact is positive and significant.
At the public health level, the guidance considers the aggregate effect of widespread device use. This includes population level outcome improvements, contribution to addressing serious public health threats, reinforcement of health system resilience and emergency preparedness, and system level benefits such as improved cost-effectiveness or scalable care delivery. Market penetration potential also matters because the number of patients who may benefit or be exposed to risk influences the public health impact assessment.
Evidence Expectations for Breakthrough Devices
MDCG 2025-9 recognises that breakthrough devices may require alternative approaches to evidence generation due to their novelty. Nevertheless, compliance with MDR and IVDR requirements remains mandatory. Manufacturers must demonstrate conformity, including an acceptable benefit-to-risk ratio, through a combination of non-clinical data, pre-clinical evaluation and clinical or performance evaluation.
Non-clinical data may include bench testing, analytical performance studies, biocompatibility, software validation and other preclinical assessments appropriate to the technology. Clinical evaluation or performance evaluation must be robust and proportionate to risk. Clinical investigations or performance studies may be necessary where existing data are insufficient. The guidance emphasises that post-market surveillance plays an active and enhanced role for breakthrough devices. PMS, PMCF and PMPF activities are expected to confirm safety and clinical or diagnostic performance over time. Comprehensive PMCF or PMPF plans, registries and ongoing data collection mechanisms should be integrated into the conformity strategy from an early stage.
Expert Panels and Breakthrough Designation
Part B of the guidance addresses procedural considerations, including the role of expert panels under Article 106 of the MDR. Expert panels are independent scientific, clinical and technical bodies that support robust and consistent assessment.
Manufacturers may submit applications for breakthrough status at any stage of development, provided sufficient supporting data are available. Panels aim to provide an opinion within 60 days. Once designated as a breakthrough device, the status is retained even if similar devices later enter the market. This provides regulatory predictability and protects early innovation efforts.
Manufacturers of certain high-risk devices, such as class III devices and class IIb active devices administering or removing medicinal products, may seek early scientific advice under Article 61(2) MDR. Panels review clinical development strategies and investigation plans, including PMCF where relevant. Breakthrough devices are prioritised for this early advice. For lower risk classes, expert panels may provide guidance on data set requirements and clinical evidence strategies, including analytical performance expectations for IVDs.
Notified Body Responsibilities for Breakthrough Devices
Notified bodies play a central role in conformity assessment of breakthrough devices. The guidance requires them to apply scientific rigour while remaining proportionate and responsive to innovation. Breakthrough dossiers should be prioritised, and notified bodies are encouraged to engage in early and structured dialogue with manufacturers regarding clinical evidence and post-market plans. Alignment with expert panel advice is expected where applicable.
Notified bodies may seek supplementary scientific input from expert panels beyond the standard clinical evaluation consultation procedure if necessary. They must also ensure fair and transparent terms for small and medium-sized enterprises, including fee structures and appropriate support. Where premarket clinical evidence is sufficient but incomplete, notified bodies may issue certificates with specific conditions, such as defined PMCF or PMPF activities and enhanced reporting obligations tailored to the device’s risk profile. Enhanced surveillance is anticipated, with more frequent reassessment of updated clinical evaluations and post-market data proportionate to clinical risk.
Strategic Implications for Manufacturers
For manufacturers, MDCG 2025-9 introduces both opportunity and responsibility. The breakthrough framework offers earlier engagement, prioritised review and structured dialogue with regulators and notified bodies. However, it also imposes heightened expectations for scientific justification, post-market follow-up and ongoing evidence generation.
Manufacturers should carefully assess whether their device meets both the novelty and significant positive clinical impact criteria before pursuing a breakthrough designation. Early planning of clinical evidence strategies, PMCF or PMPF integration and expert panel engagement will be essential. Breakthrough status does not reduce safety standards but instead reshapes how evidence is generated and assessed across the lifecycle.
LFH supports manufacturers in assessing eligibility for breakthrough designation under MDR and IVDR, preparing evidence strategies aligned with MDCG 2025-9 and navigating expert panel and notified body engagement. Our regulatory specialists help innovators balance scientific rigour with proportionate development pathways, ensuring compliance while advancing transformative technologies.
FAQs – MDCG 2025-9 Breakthrough Devices
Does MDCG 2025-9 apply to all innovative devices?
No, it applies only to devices that meet both the novelty and significant positive clinical impact criteria.
Can a device retain breakthrough status if similar devices later enter the market?
Yes, once designated, breakthrough status is retained.
Are custom made devices covered by this guidance?
No, custom made and in-house devices are outside the scope.
Does breakthrough designation reduce evidence requirements?
No, compliance with MDR and IVDR remains mandatory, although alternative evidence generation approaches may be considered.
Can SMEs apply for a breakthrough designation?
Yes, and notified bodies must ensure fair and transparent support for SMEs.
Is post-market surveillance more important for breakthrough devices?
Yes, enhanced PMS, PMCF and PMPF obligations are central to the framework.
