EU MDCG Publishes Key 2025 Guidance on Breakthrough Devices and Post-Market Surveillance
The European Union’s Medical Device Coordination Group (MDCG) has issued two important guidance documents in late 2025, providing clarity and support for stakeholders navigating the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) frameworks.
MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
Published in December 2025, MDCG 2025-9 outlines the EU’s approach to breakthrough medical devices and in vitro diagnostics — products that offer significant clinical benefits for serious or unmet medical needs. The guidance sets out criteria for identifying breakthrough devices, focusing on innovation, clinical impact, and unmet need, while still maintaining high standards of safety and performance under MDR/IVDR. It aims to help manufacturers demonstrate eligibility for BtX designation and provides a framework for a proportionate balance between pre-market evidence and post-market follow-up activities.
This guidance is seen as a significant step toward streamlining market access for cutting-edge technologies while upholding patient safety and regulatory compliance.
MDCG 2025-10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
Also published in December 2025, MDCG 2025-10 focuses on post-market surveillance obligations for both medical devices and in vitro diagnostic medical devices across the EU. The document reiterates the requirement for manufacturers to implement an effective PMS system as part of their quality management systems, as mandated by MDR/IVDR. Key elements include the systematic collection, analysis, and reporting of real-world safety and performance data throughout a device’s lifecycle, with the goal of proactively identifying risks, improving patient outcomes, and ensuring ongoing compliance.
Together, these guidance documents reflect the EU’s continued efforts to modernise regulatory support tools, encourage responsible innovation, and strengthen the surveillance of medical technologies on the market.
