Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices

Proposals under topic HORIZON-HLTH-2025-01-IND-02 should aim to deliver results that are directed, tailored towards and contributing to all the following expected outcomes:

• Notified Bodies (NBs), device developers and manufacturers adopt digitalisation in their conformity assessment procedures thus facilitating device development. As certain steps of conformity assessment do also require involvement of regulatory authorities (e.g. consultation of medicines authorities), digitalisation of these steps would also bring relevant benefit;
• Device developers and manufacturers have access to digitalised conformity assessment procedures. These procedures will become more efficient, less onerous, and more predictable, which will reduce costs and shorten the time to market access;
• Device developers and manufacturers, in particular small and medium-sized enterprises (SMEs), can direct a larger part of their resources towards the research and development of innovative devices.

Interested parties can find more information and apply on the Funding and Tenders Portal.