HEU EFS

An EFS focuses primarily on assessing the initial clinical performance and safety of a medical device, and this can help guide any potential product modifications. Conducting early feasibility studies can enable developers of medical devices to focus their efforts on products that have genuine potential to alleviate patients' suffering when it comes to debilitating or life-threatening diseases.

AIM

The HEU EFS project's aim is to establish a harmonised EU methodology for EFS to support the evidence generation pathway for developers of innovative medical devices.

With a harmonised EFS methodology, medical device developers can gain earlier insights into their product development, thus ensuring a smoother development process, while patients can ultimately benefit from access to innovative medical devices.

The objectives of the project are:

1. To conduct research and analysis on state of play of regulatory framework and characteristics and impacts of pre-market programmes
2. To build a sustainable network of stakeholders to promote the implementation of EFS in the EU
3. To develop a widely applicable and harmonised EU methodology and recommendations to uptake EFS
4. To undertake pilot use cases to test the proposed methodological framework
5. To develop instruments to monitor the performance of the EU's EFS programme
6. To implement a dedicated, sustainable, open access informative online portal dedicated to EFS and disseminate the project results and recommendations

Read more about the project at the HEU EFS website or follow it on LinkedIn.

PARTNERS

The project involves a consortium consisting of 22 public and private partners. View the partners here.

FUNDING

The project is supported by the European Union's Horizon Europe programme.