MDCG releases guidance on breakthrough devices
16 December 2025
The Medical Device Coordination Group (MDCG) has published the MDCG 2025-9 “Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746“. This guidance document introduces a structured EU framework to support the development, conformity assessment, and market access of breakthrough medical devices (BtMD) and in vitro diagnostic devices (BtIVD), thereby ensuring high safety and clinical evidence standards.
The guidance defines breakthrough devices as medical devices or IVDs that demonstrate a high degree of innovation and are expected to deliver a significant positive clinical impact on life-threatening or irreversibly debilitating conditions, or address unmet medical needs. Key criteria for BtX designation include assessing novelty, clinical impact, the state of the art, and available alternatives.
The document offers flexibility in the pre-market clinical evidence requirements, allowing for proportional consideration of post-market surveillance (PMS), post-market clinical follow-up (PMCF), and post-market performance follow-up (PMPF) when justified. Expert panels play a crucial role in the designation of BtX status, providing early scientific and pre-clinical advice, and supporting the Clinical Evaluation Consultation Procedure (CECP).
The MDCG encourages prioritisation and structured dialogue by notified bodies for BtX assessments, addressing specific considerations for high-risk and implantable devices, IVDs, devices incorporating artificial intelligence (MDAI), and SMEs. Certification under specific conditions or provisions, enhanced surveillance, and milestone-based PMCF/PMPF activities are also facilitated.
A pilot project to implement the guidance is scheduled for the second quarter of 2026.
If you are unsure whether your device belongs to the BtX or BtIVD groups, our experts can help. Get in touch!
