The Medical Device Coordination Group has published MDCG 2025-9 – Guidance on Breakthrough Devices (BtX) under Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
This guidance introduces a structured EU framework to support the development, conformity assessment, and market access of breakthrough medical devices and IVDs, while maintaining high standards of safety and clinical evidence. A pilot to roll out the guidance is expected to launch in Q2 2026.
🔍 Key points:
Defines Breakthrough Devices (BtX) as MDs or IVDs that:
– Introduce a high degree of novelty, AND
– Are expected to deliver a significant positive clinical impact for life-threatening or irreversibly debilitating conditions, or address an unmet medical need.
Establishes clear criteria for BtX designation, including assessment of novelty, clinical impact, state of the art, and available alternatives.
Introduces flexibility in pre-market clinical evidence, allowing proportionate reliance on PMS, PMCF/PMPF, when justified.
Clarifies the role of expert panels in:
– BtX status designation,
– Early scientific and pre-clinical advice,
– Clinical Evaluation Consultation Procedure (CECP).
Calls for prioritisation and structured dialogue by Notified Bodies for BtX assessments.
Addresses specific considerations for:
– High-risk and implantable devices,
– IVDs,
– MDAI, including alignment with the AI Act,
– SMEs, with emphasis on proportionality and support.
Allows certification with specific conditions or provisions, including enhanced surveillance and milestone-based PMCF/PMPF activities.
Guidance document:
https://lnkd.in/eTjiiGvs