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Strategic Analysis
This call operates as a commercialisation springboard for mature results (starting at TRL 6) originating from completed Horizon Europe Pillar II RIA/IA/PCP projects, requiring a tightly focused consortium of no more than 6 partners. Winning proposals must clearly demonstrate unencumbered IPR/knowledge asset ownership, integrate verified end users directly as beneficiaries, and outline an airtight exploitation pathway backed by early private/public co-investment commitments. Success hinges on presenting a robust business and regulatory de-risking plan that delivers direct European strategic autonomy and market scale-up within a Lump Sum structure.
TRL 6 → 8
Validation and Testing activities: This could include refining or piloting of prototypes through iterative testing, ensuring they meet the required regulatory or other standards before moving forward; testing to gain approval from potential users, or trial in real-world settings, including to understand user preferences and/or optimise outcomes; stress testing for technical feasibility to ensure the robustness of solutions at scale.
Commercialisation aspects: This could include activities around regulatory compliance standardisation or certification, development of business or pricing strategies and planning for market entry.
Scaling and Operations: This could include activities around large scale validation such as interoperability and/or standardising processes for quality assurance and control; preparations for supply chains and operational readiness; planning for ramping up manufacturing or delivery.
Stakeholder, User and Market Readiness: This could include activities that involve engaging users/customers through co-creation and iterative feedback mechanisms to refine products and strategies, and to ensure that the proposed solutions are aligned with industrial and/or societal needs, concerns and expectations.
Deployment and Investment Bridging : This could include partnering activities to expands market reach and securing the required investment commitment for the next phase by EU or national deployment programmes or investment funds.
Describe the expected scale and significance [4] of the identified wider impacts.
Include a business plan or exploitation strategy (including risks and mitigation) that will be further developed during the project. Proposals should identify the beneficiary(ies) (e.g. industry, company, public authority, etc.) responsible for the scaling-up of the solutions. The exploitation strategy should envisage a first deployment in the EU and/or Associated Countries.
End users should be represented as a beneficiary within the consortium (and identified in the proposal) to test the feasibility of the solution and to ensure that the innovations developed meet the specific needs and requirements of the demand. To support the expected outcomes of the topic, additional end users beyond the project consortium can be subcontracted for further testing and validation activities.
Research and Innovation (R&I) solutions funded under Horizon Europe Pillar II are further advanced along the innovation pathway towards uptake and deployment in the EU and/or Associated Countries, including their translation into high value products, services, processes or business models, strengthening the capacity of European public and private organisations to use innovative solutions.
End users [1] and market actors actively co-develop and validate highly innovative solutions in real-world settings, ensuring demand-side needs are integrated, helping to de-risk the innovation journey.
The EU and Associated Countries benefit from accelerated commercialisation, adoption and deployment of Horizon Europe results, thereby reinforcing societal benefits, sustainable competitiveness, resilience and strategic autonomy of the Union.
No expected impacts identified for this destination.
Strategic Technologies for Europe Platform (STEP)
highThe Strategic Technologies for Europe Platform (STEP) is an EU initiative established by Regulation (EU) 2024/795 to boost European leadership and reduce strategic dependencies in critical technology sectors. It mobilizes funding across existing EU programmes towards deep and digital technologies, clean and resource-efficient technologies, and biotechnologies.
Evaluators expect applicants to demonstrate how the proposed innovation fits within one of the critical STEP technological domains (digital/deep tech, clean tech, or biotech). Proposals should clearly articulate the technology's contribution to European sovereignty, supply-chain resilience, and potential for scaling within the Union.
Regulation (EU) No 536/2014 (on clinical trials on medicinal products for human use)
mediumRegulation (EU) No 536/2014 harmonizes the assessment and supervision processes for clinical trials across the EU through the Clinical Trials Information System (CTIS). It establishes high standards for patient safety, ethical conduct, transparency, and data reliability in clinical research on human medicinal products.
Evaluators expect health-related innovation proposals planning human trials to outline a solid regulatory roadmap compliant with the Clinical Trials Regulation. This includes clear planning for submissions via CTIS, ethical approval procedures, and data governance adhering to EU standards.
Regulation (EU) 2017/745 (on medical devices)
mediumRegulation (EU) 2017/745 (MDR) sets the legal framework governing the safety, clinical evaluation, and market placement of medical devices within the European single market. It reinforces requirements for clinical evidence, post-market surveillance, and traceability via the EUDAMED database.
For medtech innovations advancing along the development pathway, evaluators look for a clear regulatory and conformity assessment strategy. Proposals must identify the intended device classification, clinical evaluation pathway, and engagement with notified bodies.
Regulation (EU) 2017/746 (on in vitro diagnostic medical devices)
mediumRegulation (EU) 2017/746 (IVDR) establishes the regulatory standards for in vitro diagnostic medical devices for human use in the EU. It introduces a risk-based classification system, stringent clinical performance evaluation requirements, and enhanced oversight by notified bodies.
Evaluators expect diagnostic innovation projects to provide a sound regulatory translation strategy under IVDR rules. This entails specifying the device risk class, performance evaluation plans (scientific validity, analytical, and clinical performance), and steps towards CE marking.
Specific requirements
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS. Other sources may be added but not substitute EU infrastructures.
Civil applications only
Horizon Europe funds exclusively civil applications. Research with exclusive military or dual-use application is excluded.
Gender Equality Plan
Having a Gender Equality Plan (GEP) is an eligibility criterion for public bodies, research organisations, and higher education institutions from Member States and Associated Countries.
Open Science
Mandatory open access to peer-reviewed scientific publications and responsible management of research data (FAIR principles, DMP required).
Maximum consortium size
Consortia may include a maximum of 6 independent eligible entities as participants.
Exclusion of China-controlled entities
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 participate in the action.
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Admissibility conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.
Eligible countries are described in Annex B of the Work Programme General Annexes.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide.
The following additional eligibility criteria apply: consortia may include a maximum of 6 independent eligible entities as participants.
The proposals must be based on results generated within a prior multi-beneficiary project funded directly under the Clusters of Pillar II (Clusters 1 to 6), through a Research and Innovation Action (RIA), an Innovation Action (IA) or a Pre-commercial Procurement Action (PCP). Applicants may submit a proposal based on results generated within more than one such projects (from the same or different Clusters of Pillar II), however only one of these projects will be considered as primary. Applicants must explicitly state in their proposal the project concerned (or the primary project concerned in case the proposal is based on results generated within more than one projects), by providing the relevant grant number and acronym as indicated in the Funding & Tenders Portal.
The project(s) must have been completed before the submission deadline[[The ‘end date’ of the grant must be prior to the submission deadline.]]. Ongoing projects[[Projects that have an ‘end date’ after the submission deadline.]] are not considered eligible. Only projects where the granting authority for the completed project is the Commission or Executive Agency[[This means for example that projects such as the ones funded under a co-funded European Partnership or a joint undertaking are not considered eligible.]] are eligible[[Results generated within projects funded via financial support to third parties are not eligible.]].
Proposals must provide evidence[[In case of proposals that are based on results generated within more than one projects, evidence of ownership or access to the knowledge assets, including intellectual property where relevant, must be provided for all these projects.]] that the consortium owns or has access to the knowledge assets, including intellectual property, where relevant. More specifically, proposals must include at least one of the following:
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 participate in the action.
Some activities, resulting from this topic, may involve using classified background and/or producing of security sensitive results (EUCI and SEN). Please refer to the related provisions in section B Security — EU classified and sensitive information of the General Annexes.
If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).
Other eligibility conditions are described in Annex B of the Work Programme General Annexes.
Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.
To allow a faster access to funds for small collaborative consortia, grants under this topic will be funded under a Fast Track to Research and Innovation Procedure (FTRI).
Indicative timetable for evaluation and grant agreement signature will be:
To ensure a balanced project portfolio covering all Clusters of Pillar II (Clusters 1 to 6), grants will be awarded (within available budget) to proposals not only in order of ranking but at least also to those proposals that are the 2 highest ranked within different Clusters targeted[[A proposal is considered to target a Cluster of Pillar II (Cluster 1 to 6), when it is based on results generated within a prior multi-beneficiary project funded directly under that Cluster. In case of proposals that are based on results generated within more than one projects, the Cluster of the primary project -as stated by the applicants in their proposal- will be considered as being the Cluster targeted.]], provided that the proposals attain all thresholds.
Eligible proposals submitted under this topic and exceeding all the evaluation thresholds will be awarded a STEP Seal [[https://strategic-technologies.europa.eu/about/step-seal_en]].
Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.
The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.
Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.
Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].
The granting authority may, up to 4 years after the end of the action, object to a transfer of ownership or to the exclusive licensing of results, as set out in the specific provision of Annex 5.
Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.
Specific conditions are described in the specific topic of the Work Programme.
Application and evaluation form templates
Please use the application form that you will find in the Submission System. You can find examples of standard application forms in the Reference Documents page.
Standard evaluation form (HE RIA, IA) - will be used with the necessary adaptations
Guidance
Model Grant Agreements (MGA)
Call-specific instructions
Information on clinical studies (HE)
Guidance: "Lump sums - what do I need to know?"
Information on security issues/Security section (HE)
Information on security practitioners (HE)
HE Main Work Programme 2026-2027 – 1. General Introduction
HE Main Work Programme 2026-2027 – 14. Horizontal Activities
HE Main Work Programme 2026-2027 – 15. General Annexes
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
EU Financial Regulation 2024/2509
Decision authorising the use of lump sum contributions under the Horizon Europe Programme
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Evaluators operate under the Fast Track to Research and Innovation (FTRI) procedure and will apply a strict elimination filter to eligibility prerequisites before scoring:
Everything the call asks for, seen from the call's point of view. Each line shows what answers it, and which partner carries it.
This matrix lists everything the call asks for: outcomes, impacts, scope, the requirements buried in the call text, and policy alignment. Sign up free and GrantForge tracks each line against the concept you build.
| Requirement | Covered by | Carried | Status |
|---|---|---|---|
| Scope activities | |||
| SC1Validation and Testing activities: This could include refining or piloting of prototypes through iterative testing, ensuring they meet the required regulatory or other standards before moving forward; testing to gain approval from potential users, or trial in real-world settings, including to understand user preferences and/or optimise outcomes; stress testing for technical feasibility to ensure the robustness of solutions at scale. | · | · | Sign up to track |
| SC2Commercialisation aspects: This could include activities around regulatory compliance standardisation or certification, development of business or pricing strategies and planning for market entry. | · | · | Sign up to track |
| SC3Scaling and Operations: This could include activities around large scale validation such as interoperability and/or standardising processes for quality assurance and control; preparations for supply chains and operational readiness; planning for ramping up manufacturing or delivery. | · | · | Sign up to track |
| SC4Stakeholder, User and Market Readiness: This could include activities that involve engaging users/customers through co-creation and iterative feedback mechanisms to refine products and strategies, and to ensure that the proposed solutions are aligned with industrial and/or societal needs, concerns and expectations. | · | · | Sign up to track |
| SC5Deployment and Investment Bridging : This could include partnering activities to expands market reach and securing the required investment commitment for the next phase by EU or national deployment programmes or investment funds. | · | · | Sign up to track |
| SC6Describe the expected scale and significance [4] of the identified wider impacts. | · | · | Sign up to track |
| SC7Include a business plan or exploitation strategy (including risks and mitigation) that will be further developed during the project. Proposals should identify the beneficiary(ies) (e.g. industry, company, public authority, etc.) responsible for the scaling-up of the solutions. The exploitation strategy should envisage a first deployment in the EU and/or Associated Countries. | · | · | Sign up to track |
| SC8End users should be represented as a beneficiary within the consortium (and identified in the proposal) to test the feasibility of the solution and to ensure that the innovations developed meet the specific needs and requirements of the demand. To support the expected outcomes of the topic, additional end users beyond the project consortium can be subcontracted for further testing and validation activities. | · | · | Sign up to track |
| Expected outcomes | |||
| EO1Research and Innovation (R&I) solutions funded under Horizon Europe Pillar II are further advanced along the innovation pathway towards uptake and deployment in the EU and/or Associated Countries, including their translation into high value products, services, processes or business models, strengthening the capacity of European public and private organisations to use innovative solutions. | · | · | Sign up to track |
| EO2End users [1] and market actors actively co-develop and validate highly innovative solutions in real-world settings, ensuring demand-side needs are integrated, helping to de-risk the innovation journey. | · | · | Sign up to track |
| EO3The EU and Associated Countries benefit from accelerated commercialisation, adoption and deployment of Horizon Europe results, thereby reinforcing societal benefits, sustainable competitiveness, resilience and strategic autonomy of the Union. | · | · | Sign up to track |
| Other requirements | |||
| REQ1Direct end-user participation as consortium beneficiaryEnd users (public or private entities) must be represented as a beneficiary within the consortium and identified in the proposal to test solution feasibility and validate demand-side requirements; additional end users may be subcontracted. | · | · | Sign up to track |
| REQ2Integration of European space data (Copernicus and Galileo/EGNOS)If projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS. | · | · | Sign up to track |
| REQ3Clinical studies documentation and CTIS submission complianceWhere relevant, applicants must provide details of clinical studies in the dedicated annex template, comply with Clinical Trials Information System (CTIS) submission rules, and are encouraged to follow WHO guidance for best practices. | · | · | Sign up to track |
| REQ4Use of ESFRI research and technology infrastructuresProposals should focus on late-stage innovation activities, including the use of European Strategy Forum on Research Infrastructures (ESFRI) research and technology infrastructures where relevant. | · | · | Sign up to track |
| REQ5Handling of EU classified background or sensitive results (EUCI and SEN)Some activities may involve using classified background and/or producing security-sensitive results (EUCI and SEN), requiring adherence to the security provisions in General Annex B. | · | · | Sign up to track |
| REQ6Restriction on control by Chinese entities in critical technology areasIn line with restrictions on control in innovation actions in critical technology areas, entities established in an eligible country but directly or indirectly controlled by China or a legal entity established in China are not eligible to participate. | · | · | Sign up to track |
| Expected impacts | |||
| No expected impacts in this call. | |||
| Underlying policies | |||
| POL1strategic technologies for europe platformThe Strategic Technologies for Europe Platform (STEP) is an EU initiative established by Regulation (EU) 2024/795 to boost European leadership and reduce strategic dependencies in critical technology sectors. It mobilizes funding across existing EU programmes towards deep and digital technologies, clean and resource-efficient technologies, and biotechnologies. | · | · | Sign up to track |
The binding rules of this call. Items marked auto are verified by GrantForge from the call and the template. The others are yours to confirm.
LMIC entities auto-eligible
Low/middle-income country entities are automatically eligible for funding.
EU space data infrastructures
If the project uses satellite-based Earth observation, positioning, navigation or timing data/services, beneficiaries must use Copernicus and/or Galileo/EGNOS. Other sources may be added but not substitute EU infrastructures.
Civil applications only
Horizon Europe funds exclusively civil applications. Research with exclusive military or dual-use application is excluded.
Gender Equality Plan
Having a Gender Equality Plan (GEP) is an eligibility criterion for public bodies, research organisations, and higher education institutions from Member States and Associated Countries.
Open Science
Mandatory open access to peer-reviewed scientific publications and responsible management of research data (FAIR principles, DMP required).
Maximum consortium size
Consortia may include a maximum of 6 independent eligible entities as participants.
Exclusion of China-controlled entities
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 participate in the action.
5 key insights you must internalise before writing. Each is grounded in the call text and tells you what evaluators will actually look for. Share these with your consortium before drafting.
Consortia are strictly capped at 6 independent entities. Furthermore, demand-side end users cannot be relegated to advisory boards or subcontracted exclusively; they must be integrated directly as beneficiaries to validate the solution in real-world settings. Failure to meet either condition triggers immediate rejection before scoring.
Source: Evaluation_pre_award
Proposals must originate from a completed Pillar II RIA, IA, or PCP project. Evaluators apply a strict elimination filter checking for the mandatory grant agreement number and written proof of IPR ownership or a binding commitment letter. Ongoing projects or those lacking explicit IPR access documentation will not proceed to scoring.
Source: Evaluation_pre_award
The evaluation applies elevated thresholds requiring a minimum score of 4 out of 5 across all three criteria. Because the call enforces a portfolio balancing rule that guarantees awards to the top 2 proposals per Pillar II Cluster, your designation of the primary project's Cluster dictates exactly which proposals you compete against for these reserved slots.
Source: Eligibility
Under the restriction on control in innovation actions in critical technology areas, any entity directly or indirectly controlled by China or a Chinese legal entity is strictly ineligible. Consortia must rigorously vet the corporate ownership structures of all partners to avoid disqualifying the entire proposal at the eligibility check.
Source: Eligibility
Proposals operating in digital, clean tech, or biotech domains must explicitly articulate their contribution to the Strategic Technologies for Europe Platform (STEP) by demonstrating reduced strategic dependencies. Eligible proposals that pass the elevated cumulative threshold of 12 but miss direct funding will receive a STEP Seal to unlock alternative investment bridging.
Source: Scope
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