The BioMed Alliance is a partner in the CORE -MD project, a European project funded under Horizon 2020 that contributes to evidence-based decision making for medical devices. The project, which was launched in April 2021, will last three years and aims at translating expert knowledge into advice for regulatory guidance and building expertise and Regulatory Science in the clinical community. It will review methodologies for the clinical evaluation of high-risk medical devices and recommend new designs to set an appropriate balance between innovation, safety, and clinical effectiveness.

BioMed Alliance is co-leading work package 4 “Network and Community Building” and thus plays an important role in the dissemination of the results, while also ensuring input from its members is included in different parts of the project.

The consortium is led by ESC and EFORT and is composed of a mix of medical societies, patient organisations, national regulatory agencies, academic institutions, notified bodies and other health stakeholders. 

Work packages:

• WP5 Project management
• WP1 Understanding methods used to generate clinical evidence for high-risk medical devices
• WP2 Strengthening evidence for high-risk medical devices: New methods for generating clinical evidence.
• WP3 Extracting maximal value from medical device registries and real-world evidence.
• WP4 Networking and community building

For more information and results see the CORE-MD website.

‘This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 965246.’