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HORIZON EUROPE TOPIC · Cluster 1 · Health

Portable and versatile Point-of-care diagnostics

HORIZON-HLTH-2027-02-IND-02-two-stage — the expected outcomes as checkable statements, what evaluators look for in this topic, and the conditions that shape the proposal.

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ForthcomingIA · lump sumDeadline 17 February 2027EUR 5 million to EUR 7 million per project

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TopicHORIZON-HLTH-2027-02-IND-02-two-stage
StatusForthcoming
CallHORIZON-HLTH-2027-02-two-stage — Cluster 1 - Health (Two stage - 2027)
DestinationMaintaining an innovative, sustainable, and competitive EU health industry (2026-27)
Type of actionInnovation Actions · lump sum · two-stage
Opening29 October 2026
Deadlines17 February 2027 (stage 1) · 16 September 2027 (stage 2)
BudgetEUR 5 million to EUR 7 million per project · 6 projects expected · EUR 39.3 million in total
Part B page limit45 pages (standard application form; check your call)
TemplateWork Programme 2026–2027 application form

Expected outcomes

Projects should contribute to all of the expected outcomes. The topic says: “This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Maintaining an innovative, sustainable, and competitive EU health industry”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes:”

  1. EO1 Healthcare professionals dispose of diagnostic tools at the point of care that accelerate therapeutic decision making.
  2. EO2 Patients benefit from fast and accurate diagnosis leading to improved health outcomes.
  3. EO3 Thanks to more efficient diagnosis, health systems will get better evidence for disease control and prevention strategies.

Expected impacts named in the destination

The wider, long-term effects the destination seeks. Your outcomes feed them; they are not project deliverables.

  1. EI1 Health industry in Europe and Associated Countries is more competitive and sustainable, assuring European leadership in breakthrough health technologies and open strategic autonomy in essential medical supplies and (digital) technologies, contributing to job creation and economic growth, in particular with small and medium-sized enterprises (SMEs).
  2. EI2 Health industry is supported by cross-sectoral Research and Innovation in the context of convergence of health technologies (integrating medical technologies, pharmaceuticals, biotechnologies, digital health, and e-health technologies) while strengthening key market positions.
  3. EI3 Health industry is working more efficiently along the value chain from the identification of needs to the scale-up and take-up of solutions at national, regional or local level, including through early engagement with patients, healthcare providers, health authorities and regulators ensuring suitability and acceptance of solutions.
  4. EI4 Citizens, healthcare providers and health systems benefit from a swift uptake of innovative health technologies and services through the provision of evidence and guidelines for stakeholders, policymakers and regulators. These efforts offer significant improvements in health outcomes, also potentially strengthening access to healthcare for all and reducing health inequities while health industry benefits from decreased time-to-market.
  5. EI5 Citizens, healthcare providers and health systems benefit from increased health security in Europe and Associated Countries due to reliable access to key manufacturing capacity, including timely provision of essential medical supplies and technologies of particularly complex or critical supply and distribution chains.

What evaluators will look for in this topic

Expected outcomes

  • Projects should contribute to all of the expected outcomes.
  • For each outcome (EO1 to EO3), name who will use or adopt your results (a specific group, not “industry” or “society”), how they get them, and the indicator that shows the change, with baseline, target and date.
  • Use the topic's own words for each outcome, so the evaluator can tick it off.

What the scope asks for

Evaluators check the proposal against these sentences of the scope. Answer each one visibly, in the call's own words.

  • “The selection of the PoC device to be developed or optimised should be based on an objectively conducted clinical needs assessment, which includes -next to clinicians’ perspectives- the complete care pathway and system-level needs.”
  • “Moreover, a value-based concept should be applied in the choice and development of the PoC device, taking into account its Health Technology Assessment (HTA) by the relevant HTA bodies, in order to facilitate their decisions for adoption.”
  • “Proposals should be driven by a clear clinical need, integrate a value-based concept and include all the following activities:.”
  • “In general, priority should be given to approaches that are suitable for resource-limited settings.”
  • “In case of targeting infectious diseases, priority should be given to approaches enabling the distinction between viral, bacterial or fungal infections.”
  • “In case of targeting non-communicable diseases, priority should be given to approaches that are used in emergency cases where decisions can have life-saving character.”
  • “Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system.”

Conditions that shape the proposal

  • Part B, sections 1–3: 45 pages (standard application form). Text beyond the limit is not read; tables and figures count.
  • Lump sum: the budget is fixed per work package and paid when each work package is completed. Every work package needs activities and deliverables an evaluator can verify, and the effort must match the money.
  • Two-stage submission: the first stage uses a shorter proposal and is assessed on Excellence and Impact only. Check the page limit and sections in the stage-one form of your call.
  • Innovation action: evaluators expect a plausible path to commercialisation and named first users or customers.
  • Admissibility Conditions, proposal page limit and layout: “Applicants submitting a proposal for a blind evaluation (see General Annex F) must not disclose their organisation names, acronyms, logos nor names of personnel in the proposal abstract and Part B of their first-stage application (see General Annex E).”
  • Other Eligibility Conditions: “In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.”
  • Other Eligibility Conditions: “In line with the “ restriction on control in innovation actions in critical technology areas ” delineated in General Annex B of the General Annexes, entities established in an eligible country but which are directly or indirectly controlled by China or by a legal entity established in China are not eligible to…”
  • Evaluation and award: Award criteria, scoring and thresholds: “The first-stage proposals of this topic will be evaluated blindly.”
  • Evaluation and award: Submission and evaluation processes: “For the first stage, the thresholds for each criterion will be 4 (Excellence) and 4 (Impact). The overall threshold applying to the sum of the two individual scores will be set at a level that ensures the total requested budget of proposals admitted to stage 2 is as close as possible to four times the available…”
  • Evaluation and award: Submission and evaluation processes: “For the second stage, the thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.”

Impact pathway and traps

  • Users or citizens are part of the scope. Show how they take part in the design and testing, not only that they are informed.
  • The scope expects pilots or demonstration. Name the sites, the partners who run them and what is measured there.
  • Policy or regulation is in scope. Name the policy owners you will reach and what you will give them.
  • Keep outputs, outcomes and impacts apart: what you deliver, what changes when others use it, and the long-term effect.
  • For each destination impact you claim, show which of your outcomes feeds it. Destination impacts are long-term effects, not project deliverables.
  • Name the barriers outside the project (regulation, markets, user behaviour) that could block uptake, and what you will do if they do.
  • Section 2.3 (the summary canvas) is optional on this call; the old split into scientific, economic and societal impact is no longer required.
The scope, as published

Point-of-Care (PoC) medical testing has made great technical progress (e.g. improved extraction, microfluidics, miniaturisation, and data processing techniques) with PoC test accuracies nearly matching those of lab-based tests. PoC tests may thus be an alternative to laboratory testing methods, enabling faster diagnostic results and therapeutic decision making. However, PoC testing is not always achieving a completely accurate diagnosis and one of the major issues with PoC diagnostics is the occurrence of false results during testing, another one is the often-cumbersome sample preparation. Hence there is a need for PoC diagnostics that are more sensitive, selective and easy-to-use allowing for improved clinical practice. The World Health Organization (WHO) has defined a set of criteria for PoC diagnostics in primary care which, in the advent of digital technologies, has been completed with two additional features and is represented by the acronym REASSURED: R eal-time connectivity, E ase of specimen collection and environmental friendliness, A ffordable, S ensitive, S pecific, U ser-friendly, R apid and robust, E quipment-free (or equipment-modest) and D eliverable to end users. To these criteria adds the feature of “sample-to-answer” (sometimes also called “sample-to-result”) and more challenges like: Miniaturisation, power supply, versatility (nature and origin of the human sample), biocompatibility of the used materials and their suitability for mass production, readiness for high-throughput testing, quality control, regulatory compliance, environmental footprint and, last but not least, cost, which is of particular concern in resource-limited settings. All these challenges are not only valid for PoC diagnostics developed for infectious diseases, they equally apply to those that are designed to detect non-communicable diseases as well as their continuous monitoring on patients. Mobile technologies are playing an important role, especially since around 70% of the globally 7.4 billion cell phone users live in developing countries, which are the areas in direct need of advanced and more accessible PoC diagnostics (lower density of relevant health infrastructure, e.g. hospitals and laboratory medicine testing facilities). Mobile phones have not only been proposed and tested for data acquisition and readout of assays, images and other results but also for sample processing (e.g. for heating step), as have been Machine-Learning/Artificial Intelligence (ML/AI) powered algorithms that are integrated in the diagnostic devices to analyse complex biological data and detect patterns that might be missed by human analysis. The selection of the PoC device to be developed or optimised should be based on an objectively conducted clinical needs assessment, which includes -next to clinicians’ perspectives- the complete care pathway and system-level needs. Moreover, a value-based concept should be applied in the choice and development of the PoC device, taking into account its Health Technology Assessment (HTA) by the relevant HTA bodies, in order to facilitate their decisions for adoption. Proposals should be driven by a clear clinical need, integrate a value-based concept and include all the following activities: The optimisation of (the) targeted PoC diagnostic device(s) that take(s) the above-mentioned criteria, challenges and aspects into consideration. The elaboration of a comparative study clearly demonstrating the added value and improved performance of the optimised PoC diagnostic device(s) as compared to the current state of the art for the targeted diagnostic application. The conduct of clinical studies of (the) optimised PoC diagnostic medical device(s) as a preferred information source for their clinical validation; subsequent conformity assessment in agreement with requisite EU’s In-Vitro Medical Device (IVDR) or Medical Device (MDR) regulatory requirements. In general, priority should be given to approaches that are suitable for resource-limited settings. In case of targeting infectious diseases, priority should be given to approaches enabling the distinction between viral, bacterial or fungal infections. In case of targeting non-communicable diseases, priority should be given to approaches that are used in emergency cases where decisions can have life-saving character. Applicants invited to the second stage and envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.

Other topics in HORIZON-HLTH-2027-02-two-stage

Source and attribution

Topic text from the official topic page on the EU Funding & Tenders Portal, retrieved 19 October 2026. © European Union, reused under Commission Decision 2011/833/EU (CC BY 4.0). Changes: the expected outcomes and impacts are split into numbered statements, long passages are shortened, and the evaluator checklist is GrantWise's own commentary. Your call and the Work Programme always win; check them before you submit. GrantWise is independent and not affiliated with, endorsed by, or acting on behalf of the European Commission.