EMA Launches Pilot Programme for Breakthrough Medical Devices and IVDs in Q2 2026
核心洞察
The European Medicines Agency (搜索) will launch a pilot programme in Q2 2026 providing expert panel advice for developers of breakthrough medical devices and in vitro diagnostics.
Breakthrough technologies must demonstrate high novelty in device technology or clinical application and provide significant positive clinical impact for life-threatening or debilitating conditions.
The programme allows early-stage designation of breakthrough technologies and provides guidance on clinical development strategies and appropriate pre-clinical or clinical data requirements.
The European Medicines Agency (搜索) (EMA) is set to launch a pilot programme in the second quarter of 2026 that will provide expert panel advice for developers of breakthrough medical devices and in vitro diagnostic medical devices (IVDs). This initiative represents a significant step toward addressing regulatory gaps in supporting innovative medical technologies within the European Union.
Programme Foundation and Regulatory Context
The pilot programme builds upon guidance issued by the Medical Device Coordination Group (搜索) (MDCG) in December 2025 and aligns with the European Commission's proposal for revising the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The Commission's proposal recognizes that the current regulatory framework lacks sufficient support and dedicated pathways for breakthrough technologies, prompting the introduction of adaptive certification procedures.
Breakthrough Technology Criteria
To qualify for the programme, medical devices or IVDs must meet two specific criteria as outlined in MDCG 2025-9 guidance and proposed new Articles 52a(2) of the MDR and 48a(2) of the IVDR:
Novelty Requirements: The technology must introduce a high degree of novelty to the EU market regarding device technology, related clinical procedures, or clinical practice applications.
Clinical Impact Standards: The device must provide significant positive clinical impact on patients or public health for life-threatening or irreversibly debilitating diseases or conditions. This can be achieved by offering superior clinical or health impact compared to available alternatives or by fulfilling unmet medical needs where alternative options are absent or insufficient.
Programme Structure and Process
Manufacturers seeking to participate must first request an opinion from relevant expert panels to determine whether their products meet breakthrough technology criteria. The EMA will publish detailed guidance and templates for applicants before the pilot's launch.
The programme is designed to accommodate early-stage designation of breakthrough technologies, potentially occurring months to years before market entry in the EU. Expert panels, composed of independent scientific, technical, and clinical experts and administered by the EMA, will evaluate applications.
Advisory Services and Support
Once breakthrough status is confirmed, manufacturers can request advice from expert panels on their planned clinical development strategies and appropriate pre-clinical or clinical data for clinical evaluation of medical devices. For IVDs, manufacturers can seek guidance on performance evaluation strategies and appropriate analytical or clinical performance data.
The MDCG 2025-9 guidance indicates that requests for opinion may also encompass proposed post-market clinical follow-up (PMCF) activities when relevant to demonstrating ongoing safety and performance.
Industry Preparation and Information Access
The EMA will conduct an online information session on April 24 to clarify practical considerations for manufacturers intending to participate in the programme. This session will provide additional details about registration processes and programme requirements.
Strategic Objectives
This pilot programme supports the European Commission's objective to improve cost-effectiveness and overall competitiveness of the EU medtech industry by supporting innovation while maintaining high levels of health protection. The experience gained from this programme will contribute to shaping the future legal framework for breakthrough technologies as proposed in the MDR and IVDR revision.