Project information 

Full title: Harmonised Approach to Early Feasibility Studies for Medical Devices in the European Union (HEU-EFS) 

Duration: 48 months (1 October 2023 – 30 September 2027) 

Status: Ongoing 

Funding programme: Horizon Europe under Innovative Health Initiative Joint Undertaking (IHI JU), Grant agreement no. 101112185 

What will the project do? 

  • The ambition of the HEU-EFS project is to create a harmonised framework for conducting Early Feasibility Studies (EFS) in the EU. EFS are small-scale research studies or tests done in the very early stages of developing a medical device or treatment to see if it is practical, safe, and worth pursuing further. EFS help assess whether an idea or concept has potential before investing more time and resources into full-scale development and testing. Currently, there are no standardised procedural rules or guidance frameworks for carrying out EFS in the EU – a gap that the HEU-EFS project aims to fill. This also supports efforts by EU regulators to promote a stricter process for the generation of clinical evidence before medical devices can enter the market and be used by patients. 

What are the expected outcomes? 

  • Adoption of the HEU-EFS methodological framework across EU member states, creating a harmonised approach to conducting EFS in the EU. 
  • Increased number of EFS carried out in the EU due to harmonised rules and procedures. 
  • Recording and monitoring of EFS in the EU through an ad hoc database. 
  • Improved quality of clinical evidence produced, including patient contributions in medical device developments, and increased efficiency in producing evidence. 
  • Attracting more clinical research/trials and R&D investments in the EU due to harmonised and stimulating innovation environment. 
  • Building a network and fostering collaboration among relevant stakeholders. 

What is EPFs’ role? 

  • EPF is teaming up with patient organisation Global Heart Hub (GHH) to make EFS for medical devices more patient-centred by ensuring that patients are actively and meaningfully involved in the process. To do this, EPF and GHH will set up and engage a Patient Advisory Group of individuals with different profiles who will make contributions to, and give advice on, various workstreams across the project. 

Why does this matter for patients? 

Adequately including patient perspectives in Early Feasibility Studies: 

  • ensures that newly developed medical devices are better tailored to patients’ needs. 
  • supports patients’ active role in managing their own health, co-creating healthcare solutions. 

The consortium 

The consortium is a public-private partnership composed of patient organisations, research organisations, Health Technology Assessment (HTA) bodies, healthcare providers, small and medium-sized companies (health technology developers, legal experts, and a contract research organisation (CRO)), and private companies: 

  • Università Commerciale Luigi Bocconi, Italy 
  • Fundació de Recerca Clínic Barcelona – Institut d’Investigacions Biomèdiques August Pi i Sunyer (FCRB), Spain 
  • Hospital Clinic de Barcelona (HCB), Spain 
  • Agenzia nazionale per i servizi sanitari regionali (AGE.NA.S), Italy 
  • Assistance publique Hôpitaux de Paris (APHP), France 
  • Idris Oncology, Netherlands 
  • Meditrial, Italy 
  • Folkehelseinstituttet – Norwegian Institute of Public Health (NIPH), Norway 
  • Trinity College Dublin, Ireland 
  • Philipps-Universität Marburg (UMR), Germany 
  • Region Syddanmark – Region of Southern Denmark (CIMT), Denmark 
  • Carmat, France 
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Italy 
  • European Patients’ Forum (EPF), Belgium 
  • Newronika, Italy 
  • Global Heart Hub (GHH), Ireland 
  • Qurasoft, Germany 
  • Edwards Lifesciences, Belgium 
  • Edwards Lifesciences, Switzerland 
  • Edwards Lifesciences, Germany 
  • Edwards Lifesciences, France 
  • Edwards Lifesciences, Netherlands 
  • Edwards Lifesciences, United States 
  • Medtronic Bakken Research Center (Medtronic), Netherlands 
  • Sofradim Production, France 
  • W.L. Gore & Associati (Gore), Italy 
  • W.L. Gore & Associates (Gore), Netherlands 
  • Philips Medical Systems Nederland, Netherlands 
  • Abbott Vascular International, Belgium 
  • Abbott, Netherlands 
  • Abbott, Germany 
  • Abbott, France 
  • Abbott Laboratories, United Kingdom 
  • St. Jude Medical Coordination Center, Belgium 
  • St. Jude Medical Cardiology Division, United States 
  • St. Jude Medical Business Services, United States 
  • Evalve, United States 
  • Synthes, Switzerland