The HEU-EFS project has submitted its second set of recommendations on the proposed targeted revision of the European Union Medical Device Regulation (EU MDR), following the publication of the European Commission’s revision proposal in December 2025.
Building on its previous submission, the consortium welcomes several positive developments in the proposed revision, including greater emphasis on dialogue with regulators and improvements in the management of clinical investigations throughout the medical device lifecycle. At the same time, HEU-EFS highlights several areas where additional clarification and targeted measures could further strengthen Europe’s ability to support innovative medical technologies and early clinical research.
A key recommendation from the consortium is the explicit recognition of Early Feasibility Studies (EFS) within the MDR framework.
EFS play a crucial role in the development of innovative medical devices by generating early clinical evidence and enabling iterative improvements before final device design is finalised. While the revised proposal acknowledges various types of exploratory investigations, EFS are not specifically referenced.
The HEU-EFS consortium recommends formally recognising EFS, including their different development stages, and aligning terminology with internationally recognised standards such as ISO 14155:2020. Such recognition would help create a clearer clinical development pathway, improve consistency across Member States, and support future initiatives aimed at making Europe a more attractive location for early-stage clinical research.
The proposed MDR revision introduces new provisions encouraging dialogue between manufacturers and notified bodies, an important step towards greater regulatory predictability.
However, HEU-EFS believes similar opportunities should be available between manufacturers and National Competent Authorities (NCAs) during the planning and conduct of clinical investigations. Early scientific and regulatory discussions can help sponsors design appropriate evidence-generation strategies, particularly for highly innovative and high-risk medical devices.
The consortium therefore recommends introducing structured and voluntary dialogue mechanisms throughout the clinical investigation process, helping developers navigate regulatory requirements more efficiently while maintaining high standards of patient protection.
Another area highlighted by HEU-EFS relates to the timing of non-clinical testing requirements.
Early-stage investigations often seek to answer fundamental questions about device performance and design. In some cases, not all non-clinical testing can reasonably be completed before clinical studies begin. The consortium proposes a more risk-based approach that would ensure participant safety while allowing certain non-critical tests to be completed later in the development process when scientifically justified.
This approach could help facilitate iterative innovation without compromising safety.
Medical device development is frequently an iterative process. Insights gained during early clinical investigations may lead to design improvements that enhance safety, usability, or performance.
HEU-EFS therefore calls for clearer guidance on how design modifications should be managed during early-stage clinical investigations. Greater clarity would help sponsors understand when modifications require amendments and when a complete resubmission is necessary, reducing unnecessary administrative burden while preserving regulatory oversight.
The consortium also highlights the need for a dedicated and more predictable review process for Early Feasibility Studies across Europe.
Current implementation can vary significantly between Member States, creating uncertainty for innovators. HEU-EFS recommends exploring a dedicated submission and review pathway, supported by clear timelines, templates, and guidance, to improve efficiency and encourage investment in clinical research within Europe.
Through these recommendations, the HEU-EFS project aims to contribute to a regulatory framework that supports innovation while maintaining the highest levels of patient safety.
By recognising Early Feasibility Studies, encouraging early dialogue between developers and regulators, and enabling more flexible and proportionate clinical development pathways, Europe can strengthen its position as a global leader in medical device innovation and bring promising technologies to patients more efficiently.