Harmonised approach to early feasibility studies for medical devices in the European Union


Before a new medical device can be released to patients, evidence is needed regarding its safety and effectiveness. An evidence generation plan, prepared in the early stages of product development and engaging all relevant stakeholders, is key here. The plan aims to highlight the benefits of the new device, ensure that its safety and effectiveness align with regulatory expectations, and anticipate future evidence requirements.

Early Feasibility Studies (EFS) constitute a crucial phase in the journey towards device approval. An EFS is a clinical study conducted on a medical device in the early developmental stages. Typically involving a small number of participants, an EFS primarily assesses the initial clinical safety and performance of the device, providing guidance for product modifications. EFS play a pivotal role in enabling medical device developers to focus their efforts on products with genuine potential to improve access for patients with unmet needs or with life-threatening or highly debilitating diseases.

The aim of HEU-EFS is to develop a harmonised framework and accompanying recommendations for conducting EFS in the EU. By facilitating EFS in the EU, project seeks to bring Europe in line with the United States, which already has a dedicated EFS programme. HEU-EFS will therefore enhance the EU's competitiveness.  Even more importantly, it will ensure that patients in the EU gain access to innovative medical technologies that are safe, effective, and aligned with their needs, and will improve clinical excellence for healthcare professionals in the EU.

The HEU-EFS project's methodological framework will undergo testing and refinement through pilot use cases. The final methodology, along with templates, instruments for monitoring the EFS programme, and educational materials, will be published on an open-access, dedicated online portal. This portal will also feature templates and online tools dedicated to all relevant stakeholders involved in EFS.


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Universities, research organisations, public bodies, non-profit groups
  • Agenzia Nazionale Per I Servizi Sanitari Regionali, Roma, Italy
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Folkehelseinstituttet, Oslo, Norway
  • Fondazione Policlinico Universitario Agostino Gemelli Irccs, Roma, Italy
  • Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer, Barcelona, Spain
  • Philipps Universitaet Marburg, Marburg, Germany
  • Region Syddanmark, Vejle, Denmark
  • Trinity College Dublin, Dublin, Ireland
  • Universita Commerciale Luigi Bocconi, Milan, Italy
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Carmat, Velizy Villacoublay, France
  • Idris Oncology B.V., Leiden, Netherlands
  • Meditrial S.R.L., Roma, Italy
  • Newronika S.A, Milano, Italy
  • Qurasoft GMBH, Koblenz, Germany
Patient organisations
  • Forum Des Patients Europeens, 1040, Belgium
  • Global Heart Hub Company Limited By Guarantee, Galway, Ireland
Third parties
  • Abbott BV, Hoofddorp, Netherlands
  • Abbott France, Rungis cedex, France
  • Abbott GMBH & Co Kg, Wiesbaden, Germany
  • Abbott Laboratories Limited, Maidenhead, United Kingdom
  • Edwards Lifesciences AG, Nyon, Switzerland
  • Edwards Lifesciences BV, Breda, Netherlands
  • Edwards Lifesciences GMBH, Unterschleissheim, Germany
  • Edwards Lifesciences Llc, Irvine California, United States
  • Edwards Lifesciences SAS, Guyancourt, France
  • Evalve, Inc, Menlo Park, United States
  • Hospital Clinic De Barcelona, Barcelona, Spain
  • Sofradim Production Sasu, Trevoux, France
  • St Jude Medical Business Services Inc, Plymouth, United States
  • St Jude Medical Cardiology Division Inc, St Paul, United States
  • St Jude Medical Coordination Center, Zaventem, Belgium
  • W L Gore & Associates BV, Tilburg, Netherlands
IHI industry partners
  • Abbott Vascular International, Diegem, Belgium
  • Edwards Lifesciences Belgium BV, Dilbeek, Belgium
  • Medtronic Bakken Research Center B.V., Maastricht, Netherlands
  • Philips Medical Systems Nederland BV, Best, Netherlands
  • Synthes GMBH, Zuchwil, Switzerland
  • W.L. Gore & Associati S.R.L., Verona, Italy

NameEU funding in €
Agenzia Nazionale Per I Servizi Sanitari Regionali575 380
Assistance Publique Hopitaux De Paris725 494
Carmat112 500
Folkehelseinstituttet1 087 221
Fondazione Policlinico Universitario Agostino Gemelli Irccs478 500
Forum Des Patients Europeens329 375
Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer273 720
Global Heart Hub Company Limited By Guarantee260 616
Idris Oncology B.V.68 450
Meditrial S.R.L.520 000
Newronika S.A183 125
Philipps Universitaet Marburg626 274
Qurasoft GMBH102 500
Region Syddanmark313 910
Trinity College Dublin729 880
Universita Commerciale Luigi Bocconi3 999 489
Third parties
NameFunding in €
Hospital Clinic De Barcelona145 764
Total Cost10 532 198