HARMONISED APPROACH TO EARLY FEASIBILITY STUDIES FOR MEDICAL DEVICES IN THE EUROPEAN UNION

EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs.

To be effective this approach requires evidence generation plan to be developed since early stages of product development, by engaging all relevant stakeholders.At present, in the EU there are no standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies (EFS), clinical investigations allowed by ISO 14155:2020 conducted early in the development aiming to inform the product development.The ambition of the HEU-EFS project is to develop a harmonised framework for the EU EFS Program, as one integrated step of evidence generation cycle.

Project objectives include: (1) conducting research/analysis on state of play (i.e., characteristics, challenges, impacts) of pre-market programs for MDs, including EFS; (2) building a sustainable network of stakeholders at EU/national level to promote/support EFS implementation; (3) developing a sound, widely applicable, harmonised EU methodology and formulating recommendations to uptake EFS; (4) undertaking pilots to test the proposed framework; (5) developing instruments to monitor the EFS performance; and (6) implementing a dedicated, sustainable, open access online portal dedicated to EFS methodological framework, best practices and network.To achieve these goals, the HEU-EFS consortium has been designed including a wide range of relevant stakeholders: research organisations, HTA bodies, patient organizations, healthcare providers, SMEs (including health technology developers, legal experts, and a CRO), and 6 major private companies that are part of a pre-identified industry consortium.

An Advisory Board made of competent authorities, notified bodies, medical and biomedical engineering professional associations, networks and industry trade association will collaborate to the success of the initiative.