The @IHIEurope HEU-EFS project has officially launched recently at the Bocconi University in Milan

The @IHIEurope HEU-EFS project has officially launched recently at the Bocconi University in Milan

Press Release | 19.12.2023

The @IHIEurope HEU-EFS project, which stands for "Harmonized Approach to Early Feasibility Studies for Medical Devices in the European Union" has officially launched recently at the Bocconi University in Milan. 

EU regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonized lifecycle approach for clinical evidence generation for Medical Devices. To be effective, this approach requires evidence generation strategy to be planned since early stages of the product design and development stage by engaging all relevant stakeholders. Evidence generation strategy could include Early Feasibility Studies (EFS), a type of Clinical Investigation which is described by the ISO 14155:2020 as a study conducted early in the development of a medical device, aiming to provide initial information and that could guide device modifications.

Currently, in the EU, there are no optimal standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies, but to overcome this situation the HEU-EFS consortium has been designed.

The ambition of the @IHIEurope HEU-EFS project is to develop a harmonized framework for the EU EFS program for medical devices, as one integrated step of evidence generation cycle. Project objectives include:


  1. Conducting research/analysis on methods currently being applied in pre-market programs for Medical Devices, including Early Feasibility Studies
  2. Building a sustainable network of stakeholders at EU/National Level to promote/support Early Feasibility Studies implementation
  3. Developing a sound, widely applicable, harmonized EU methodology and formulation recommendations to uptake Early Feasilibility Studies
  4. Undertaking pilots to test the proposed framework
  5. Developing instruments to monitor the Early Feasibility Studies performance
  6. Implementing a dedicated, sustainable, open access online portal dedicated to Early Feasibility Studies methodological framework, best practices and network

Fundació Clínic per a la Recerca Biomédica and Hospital Clínic de Barcelona are members of the HEU-EFS consortium, which includes 22 partners from the public and private sectors. This diverse group brings together universities, hospitals, patient associations, contract research organisations, HTA agencies, SMEs, and large healthcare companies. Besides the relevant stakeholders, it will also involve the collaboration of an Advisory Board made of Competent Authorities, Notified Bodies, Medical and Biomedical Engineering Professional Associations, Networks and Industry Trade Associations. Collaboration between the stakeholders and the Advisory Board will indeed lead to the success of the initiative.

The HEU-EFS project is supported by the Innovative Health Initiative Joint Undertaking (JU) under grant agreement No 101112185. The JU receives support from the European Union’s Horizon Europe research and innovation programme and life science industries represented by MedTech Europe, COCIR, EFPIA, Vaccines Europe, and EuropaBio.

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