The consortium has 22 partners among which there are universities, hospitals, contract research organisations (CROs), patient associations, health technology assessment agencies and small- and medium-sized firms, 6 industrial partners, and an extensive Advisory Board with regulatory authorities, notified bodies and professional associations.

Global Heart Hub is part of the consortium and is teaming up with the European Patients’ Forum (EPF) to advance patient centricity in the project.

Why is the project important?

In recent years, regulators in various countries have been taking a closer look at how health technologies get approved for the market. Attention has been paid to the quantity, type and quality of evidence needed for the approval of medical devices, which has been traditionally considered weaker than for drugs and sometimes insufficient to fully ensure patients’ safety, especially for implantable, high-risk medical devices. For this reason, EU Regulations on medical devices, in-vitro diagnostics, and Health Technology Assessment (HTA) were established to promote a stricter process for clinical evidence generation before medical devices can enter the market and be used by patients.

This is where EFS come in. 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 guidelines for conducting EFS in the EU. The ambition of the HEU-EFS project is to create a harmonised framework for the EU EFS programme. This programme is a crucial opportunity to introduce patient perspectives early on, benefitting all stakeholders involved in the development and use of medical devices.

More information is available here.