Brussels, 24 March 2025
The European Health and Digital Executive Agency (HaDEA) has published the call for tenders HADEA/2025/CPN/0006 – Development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device.
This call for tenders aims to speed up the development of a point-of-care diagnostic medical device that can provide antimicrobial susceptibility testing (AST) results on the bacteria or fungi causing an infection in humans, within one hour or less from sample collection, and ideally, to also allow for pathogen identification. Diagnostic tests that allow for pathogen identification (in addition to AST) should aim at identifying at least one of the bacteria listed in the 2024 WHO bacterial pathogen priority list and/or the fungi Candida spp., and/or Aspergillus fumigatus.
It also has the objective of speeding up the development of rapid, point-of-care AST devices currently in the pipeline. The proposed product shall be at minimum technology readiness level (TRL) 3 onwards with a clear pathway for CE marking in the EU. By the end of the contract, the product developed should aim at reaching system complete and qualified (TRL 8). Tenders aiming at early TRLs will be considered, as long as the product is working towards certification.
Estimated budget: €12,860,000
Interested parties are invited to apply on the Funding and Tenders Portal
The deadline to apply to the first step of the procedure is 12 May 2025, 16:00 CET. Invitations to submit an offer for step 2 will be indicatively sent out at the beginning of June, with a deadline for step 2 indicatively in early September.
A dedicated info session open to all economic operators interested in the call will be organised shortly.
Background
EU4Health is the fourth and largest of the EU health programmes. The EU4Health programme goes beyond an ambitious response to the COVID-19 crisis to address the resilience of European healthcare systems. The programme provides funding to national authorities, health organisations and other bodies through grants and public procurement, contributing to a healthier Europe.
HaDEA manages the vast majority of the total EU4Health budget and implements the programme by managing calls for proposals and tenders from 2021 to 2027.
Source – HaDEA