Development of a rapid point-of-care antimicrobial susceptibility testing diagnostic medical device

Amounts and figures

Description

This call for tenders aims to speed up the development of a point-of-care diagnostic medical device that can provide antimicrobial susceptibility results on the bacteria or fungi causing an infection in humans, within one hour or less from subject 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. The call aims to speed 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.

Award criteria

Awards

Official publications

• Facilitating the implementation of decentralised manufacturing for biotech medicinal products
  Published: 21 October 2026
• Implementation of the new SoHO Regulation: training and networking of SoHO Competent Authorities’ staff for oversight
  Published: 7 October 2026
• Capacity Reservation for Personal Protective Equipment Pilot
  Published: 29 September 2026
• Strengthening national implementation of organ transplant practices, in particular through cooperation between national authorities and…
  Published: 24 September 2026
• Supply of antiviral to respond to the Andes Hantavirus outbreak
  Published: 27 August 2026
• Supply of point of care diagnostic to respond to the Ebola Bundibugyo outbreak
  Published: 27 August 2026
• Supply of RT-PCR diagnostic kits to respond to the Ebola Bundibugyo outbreak
  Published: 24 August 2026
• Capacity Reservation for Personal Protective Equipment Pilot
  Published: 22 July 2026
• Harmonising the implementation of EU legal requirements in the fields of Food, Feed, Animal By-products and Food Processing Technologies…
  Published: 13 July 2026
• Harmonising the implementation of EU legal requirements in the fields of Food, Feed, Animal By-products and Food Processing Technologies…
  Published: 7 July 2026

Previous and next from Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency

• Enhancing Animal Health and Welfare in EU Member States, Candidate, and Neighbourhood Countries: Harmonising the Implementation of EU Legal… — 2 March 2026
• Strategic Upskilling and/or Reskilling for the Space Industry Workforce — 17 February 2026
• Implementation of the new SoHO Regulation: training and networking of SoHO Competent Authorities’ staff for oversight — 23 December 2025
• Strengthening national implementation of organ transplant practices, in particular through cooperation between national authorities and… — 1 December 2025
• Service contract to translate and validate the European medical device nomenclature (EMDN) and the International medical device regulators… — 25 November 2025
• Strengthening national implementation of organ transplant practices, in particular through cooperation between national authorities and… — 21 November 2025

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Frequently asked questions

What is the estimated value of this tender?

The estimated value published by the buyer is €12,860,000.

Who is the buyer of this tender?

The contracting authority is Health and Digital Executive Agency (HaDEA) , HADEA - Health and Digital Executive Agency (European Union).

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