What is new for clinical investigations of medical devices in Europe - dissecting the MDR evaluation

The Evaluation of the Medical Device Regulation (MDR), published yesterday, the 16.12.2025, spans nearly 200 pages — a reflection of both progress and complexity.

The MDR was introduced to address key issues: insufficient safety of medical devices, barriers within the EU internal market, and fragmented or incomplete data.

Over the years, the number of clinical investigation applications has remained stable, with around 85% approved. However, variations between countries persist, prompting calls for a central EU structure to coordinate multi-national clinical investigations and improve transparency. Encouragingly, research-related studies and post-market clinical follow-ups have increased, signalling ongoing innovation and stronger clinical evidence.

While the new post-market surveillance and vigilance systems have enhanced coordination and safety monitoring, gaps remain. Resource constraints and uneven implementation still limit the full potential of the MDR framework — but the direction of travel is clearly positive.