Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices
Maintaining an innovative, sustainable, and competitive EU health industry
Amount not specified
16/09/2025
Private Business, Research Institution, Public Institution
Trusted by
What is the Digitalisation of conformity assessment procedures of medical devices and in vitro diagnostic medical devices Call?
Expected Outcomes
• Conformity assessment procedures that are more efficient, less onerous and more predictable, leading to reduced costs and shorter time-to-market for medical and in vitro diagnostic devices
• Enhanced capacity of SMEs to redirect resources from administrative processes to research and development of innovative devices
• Improved transparency, accuracy, interoperability and communication among stakeholders through pre-defined data elements, automated completeness checks, error-rate reduction and single-entry information exchanges
Scope Requirements
• Address all steps of the MDR/IVDR conformity assessment process, from manufacturer preparation of technical documentation and pre-application activities through to issuance of the certificate by an NB
• Engage all key actors: device manufacturers (including SMEs), Notified Bodies (public/private, small/large, covering medical and in vitro diagnostic devices), EU reference laboratories, expert panels and consulted regulatory agencies
• Demonstrate a major, Europe-wide step towards digitalisation under the existing MDR/IVDR regulatory framework (no proposals to change regulations)
• Ensure a representative mix of NBs and manufacturers across Member States and Associated Countries, with strong consensus-building among stakeholders
• Optionally liaise with the ongoing EC-commissioned study on monitoring the availability of medical devices in the EU market
Special Conditions
• Total indicative budget for this topic: EUR 2 000 000, one grant, single-stage submission; coordinator must be a legal entity in an EU Member State or Associated Country
• Eligible participants and conditions follow General Annexes A–G: use of Copernicus/Galileo if satellite data are used; US NIH entities may exceptionally receive EU funding; exclusion of entities assessed as “high-risk suppliers” of EU communication networks; specific page limits, thresholds (Excellence 4, Impact 4, Implementation 4, total 12)
• Governance of any developed IT infrastructure is outside the scope
• No amendments to MDR/IVDR requirements are permitted
Open from: 22/05/2025
Deadline:16/09/2025
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