Emerging Health Technologies reports 2026-2028 pursuant to Regulation (EU) 2021/2282 on Health Technology Assessment

HaDEA is procuring preparation and finalisation of Emerging Health Technologies (EHT) reports for 2026–2028 under Article 22 of Regulation (EU) 2021/2282 (tender HADEA/2026/MVP/0034-EXA) via a negotiated procedure. The contract is for services with an estimated value of €130,000 and a planned duration of 36 months. Participation is strictly limited to appointed representatives of the EHT Subgroup (EHT SG) of the Member States Coordination Group on HTA due to access to confidential data. Registration and submission are via the EU Funding & Tenders Portal (EXA registration deadline 30 May 2026, planned contract award 3 June 2026).

What it funds

Scope

Contract for preparation and finalisation of Emerging Health Technologies (EHT) reports for 2026 2028 under Regulation (EU) 2021/2282. Reports must assess expected clinical impact and organisational and financial consequences for national healthcare systems and include a public anonymised version.

Who can apply:Only appointed representatives of the EHT Subgroup of the Member States Coordination Group on HTA (EHT SG) may participate and access confidential data; this is a negotiated procedure restricted to those representatives ¹.

1. 1Lead contracting authority: Health and Digital Executive Agency (HaDEA).
2. 2Procedure type: negotiated, restricted to EHT SG appointed representatives; submission registration deadline 2026-05-30.

Application and full tender documents via the EU Funding & Tenders Portal tender page Tender details. ¹

Footnotes

1. 1Source: Tender notice HADEA/2026/MVP/0034-EXA on the EU Funding & Tenders Portal.

Opportunity summary

This is a procurement (tender) managed via the Funding & Tenders Portal and tender identifier HADEA/2026/MVP/0034-EXA for the preparation and finalisation of Emerging Health Technologies (EHT) reports covering 2026 to 2028, pursuant to Article 22 of Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR). The contract is for services to produce EHT reports that assess expected major impacts on patients, public health and health systems, based on existing scientific reports and relevant information sources, and to produce a public version containing anonymised, aggregated non-confidential information. The contract duration is planned for 36 months, with an estimated overall contract value of €130,000 and CPV main code 73200000.

Contracting authority:Health and Digital Executive Agency (HaDEA). The procurement is entrusted by the Member States Coordination Group on HTA (HTACG) to its Emerging Health Technologies Subgroup (EHT SG), and the contractor will work in close consultation and coordination with, and on behalf of, the EHT SG.

Key dates and procedural points:Publication/first ingest dates: 13 May 2026. Planned CFT date: 3 June 2026 (Europe/Brussels timezone). Registration deadline shown: 30 May 2026 23:59:59 (Europe/Brussels). Submission method: ESUBMISSION via the Funding and Tenders Portal. Procedure: negotiated procedure restricted to appointed representatives of the EHT Subgroup (EHT SG). Estimated duration: 36 months. Estimated overall contract amount: €130,000.

Eligibility and who may apply

Participation is restricted. Only appointed representatives of the Emerging Health Technologies Subgroup (EHT SG) of the Member States Coordination Group on HTA may participate and express interest in this negotiated procedure and may access and process the relevant confidential data under the legal framework (HTAR and Implementing Regulations). The tender therefore is not open to general market participants; it is reserved to those authorised and appointed as EHT SG representatives by Member States.

Structured extraction: eligibility, funding and process

1. 1Eligible Applicant Types: Only appointed representatives of the EHT Subgroup (EHT SG). Practically this means nominated individuals/organisations designated by EU Member States to serve in the EHT SG. Not open to the general public, SMEs, universities, NGOs, or other market actors unless specifically appointed as EHT SG representatives.
2. 2Funding Type: Procurement / service contract (tender). The contracting authority will pay the successful contractor for services rendered (monetary payment under a public contract).
3. 3Consortium Requirement: Other. The procedure is a negotiated procedure limited to appointed EHT SG representatives. The call text indicates participation and expression of interest are limited to those appointed; it does not explicitly require a consortium. Given the negotiated nature, a single contractor is expected to be awarded, but appointed representatives could be organisational entities that may subcontract according to contract rules. Clarification will be provided in the formal tender documentation.
4. 4Beneficiary Scope (Geographic Eligibility): EU Member States via appointed EHT SG representatives. The legal basis is EU Regulation (EU) 2021/2282, and the EHT SG is part of the Member States Coordination Group on HTA. Therefore eligibility is limited to Member State-appointed representatives (EU).
5. 5Target Sector: Health policy and Health Technology Assessment. The subject is assessment of Emerging Health Technologies (EHT) with focus on clinical impact and organisational and financial consequences for national healthcare systems.
6. 6Mentioned Countries: No individual Member States are listed by name in the provided text. The opportunity is EU-level and applies to EHT SG appointed representatives from EU Member States.
7. 7Project Stage: Analysis, synthesis and reporting. The work is policy/assessment stage (research/reporting/validation), not product development or commercialization. Expected maturity: research/analysis and policy assessment leading to public reporting and recommendations.
8. 8Funding Amount: Estimated overall contract amount €130,000 (EUR). This is the total estimated value for the three-year period.
9. 9Application Type: Negotiated procedure restricted to appointed EHT SG representatives. Registration and submission are via the Funding and Tenders Portal (ESUBMISSION). The portal registration deadline indicated: 30 May 2026. The open/competition stage is effectively limited by appointment; therefore it functions as invitation-only within the appointed group.
10. 10Nature of Support: Money in exchange for services (procurement/service contract). The successful tenderer will deliver services (preparation and finalisation of reports) and receive payment under the contract.
11. 11Application Stages: Other. The procurement is a negotiated procedure limited to appointed representatives. Typical negotiated procedures include at least one selection phase and then negotiation/award. The public metadata does not spell out multiple formal stages; expect a limited number of stages (registration/confirmation of appointment, submission of proposal/technical and financial offer, evaluation and award).
12. 12Success Rates: Very high selectivity but practically low competition because only appointed EHT SG representatives can participate. From the public information the likely outcome is a single awarded contractor; therefore success rate for eligible appointed participants depends on the number of appointed representatives submitting offers but cannot be quantified from the available data.
13. 13Co-funding Requirement: No co-funding is indicated in the tender metadata. This is a public procurement for services where the authority pays the contractor; there is no requirement for applicants to bring matching funds mentioned in the provided information.
14. 14Templates: No specific application templates were included in the scraped content. Submission is via the Funding and Tenders Portal eSubmission system. Formal tender documents, invitation instructions, technical specifications, selection and award criteria, and any templates will be available in the full call for tenders package on the Portal when published. Applicants should consult the Funding & Tenders Portal and the HaDEA pages for downloadable CFT documents and forms. The CFT documents section in the scraped data is empty; therefore applicants must review the official tender notice on the portal for mandatory templates, terms of reference, and required deliverable formats.

Scope and required outputs

The contractor will be primarily responsible for preparing and finalising Emerging Health Technologies reports for the 2026-2028 period. Reports must be based on existing scientific reports and initiatives, and on information from relevant sources (including sources listed in Article 22(2) of the HTA Regulation). Reports shall in particular address: estimated clinical impact; potential organisational consequences for national healthcare systems; potential financial consequences for national healthcare systems. The contractor must also produce a public version of each report in accordance with Article 30(3)(m) of the HTA Regulation, containing anonymised, aggregated and non-confidential information. The contractor will perform the work in close consultation and coordination with the EHT SG and in line with the HTA Regulation and its Implementing Regulations.

Confidential data access and handling:Only appointed representatives of the EHT SG may access and process relevant confidential data in accordance with the HTA Regulation and Implementing Regulations. The tender explicitly restricts participation to those appointed representatives because the work will involve confidential information that has legal protections and handling requirements. Contractors and any subcontractors will need to comply fully with confidentiality, data protection and legal requirements specified in the tender dossier.

Practical implications for potential applicants

This procurement is not a standard open call for market suppliers. Only Member State-appointed EHT SG representatives may express interest and submit under this negotiated procedure. Organisations or experts not appointed to the EHT SG cannot legitimately participate unless formally designated. Appointed representatives should prepare to demonstrate capacity and experience in health technology assessment, health policy analysis, clinical impact assessment, and analysis of organisational and financial impacts on healthcare systems. The contractor is expected to coordinate closely with the EHT SG and HaDEA and to deliver public and confidential report versions in the formats and timelines laid out in the full tender documentation. For administrative steps, appointed representatives must register and submit via the Funding & Tenders Portal using the eSubmission tool.

• Expected required expertise: HTA methodology; clinical evidence appraisal; health economics; health systems and organisational analysis; scientific literature synthesis; report drafting for policy audiences.
• Deliverables likely required: confidential EHT reports; public anonymised versions; stakeholder consultation records; data management and confidentiality compliance documentation.
• Administrative requirements: compliance with eSubmission rules, required declarations, and any standard HaDEA procurement contractual clauses.

For full tender documents, technical specifications, award and selection criteria, templates and other procurement documents consult the Funding & Tenders Portal entry for this tender and the HaDEA website. The public tender reference is available on the portal Tender details ¹.

Comprehensive summary

This tender procures expert services to prepare Emerging Health Technologies reports for 2026-2028 under Article 22 of Regulation (EU) 2021/2282 (HTA Regulation). The scope covers synthesis of existing scientific evidence and data to estimate clinical, organisational and financial impacts of EHTs on national healthcare systems, and requires production of both confidential and public anonymised report versions. The procurement is handled by HaDEA on behalf of the Member States Coordination Group on HTA and is executed through the EHT Subgroup; participation is strictly limited to appointed EHT SG representatives because access to confidential data is required. The contract is for services, has an estimated total value of €130,000 for a 36-month period, uses the Funding & Tenders Portal eSubmission, and follows a negotiated restricted procedure. Interested parties must be formally appointed to the EHT SG to participate. Full tender documents, templates and evaluation criteria will be available on the Funding & Tenders Portal; appointed representatives should register and consult the portal to obtain all required documentation and formal instructions for submission ¹.

Footnotes

1. 1Official tender publication and further procurement documents are published on the Funding & Tenders Portal at the above link. Registered and appointed EHT SG representatives should use the portal to access the full CFT documentation, templates and submission forms.

Overview

This is a negotiated tender procedure (call identifier HADEA/2026/MVP/0034-EXA) issued by the European Health and Digital Executive Agency (HaDEA) for the preparation of Emerging Health Technologies (EHT) reports for the period 2026-2028, pursuant to Article 22 of Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR). The reports will identify and analyze emerging health technologies expected to significantly impact patients, public health, or healthcare systems. They must cover estimated clinical impact, potential organisational and financial consequences for national healthcare systems, and include a public version with anonymised, aggregated, non-confidential information as per Article 30(3)(m) of the HTAR. The work is entrusted to the Member States Coordination Group on HTA (HTACG) and its EHT Subgroup (EHT SG), with the contractor responsible for preparation and finalisation in close coordination with the EHT SG.

Eligibility and Participation

Participation is strictly limited to appointed representatives of the EHT Subgroup of the HTACG. Only these representatives may express interest and participate in this negotiated procedure, as they are the only entities authorised to access and process relevant confidential data under the HTAR and implementing regulations. General applicants, SMEs, or other entities are not eligible. This restriction ensures compliance with data protection and procedural rules.

Contract Details

Estimated Value:€130,000.

Duration:36 months.

CPV Code:73200000 (Research and development consultancy services).

Procurement Type:Services contract via negotiated procedure without prior publication.

Key Deadlines

• Publication Date: 13 May 2026.
• EXA Registration Deadline: 30 May 2026, 23:59 CEST.
• Planned Contract Award Date: 3 June 2026.

Scope of Work

The contractor will base reports on existing scientific reports, initiatives, and information from sources listed in Article 22(2) of the HTAR. Reports must be prepared annually for 2026-2028, with both confidential and public versions. Close consultation with the EHT SG is required throughout, including coordination on content, data handling, and finalisation. Only EHT SG representatives handle confidential data.

Regulatory Context

Regulation (EU) 2021/2282 entered into force on 11 January 2022 and became applicable from 12 January 2025. It establishes joint clinical assessments (JCA) for certain medicinal products and medical devices, with implementing acts like Commission Implementing Regulation (EU) 2025/2086 providing procedural rules, templates, and cooperation frameworks for JCAs of medical devices and in vitro diagnostics. The EHT reports support this framework by anticipating impacts of innovative technologies, such as advanced therapeutics and oncology assets, aligning with broader EU health initiatives like Europe's Beating Cancer Plan.

Contracting Authority

Health and Digital Executive Agency (HaDEA), responsible for implementing EU funding in health, digital, and related fields, including EU4Health and Horizon Europe Cluster 1 (Health). HaDEA Website

Application Process

Eligible EHT SG representatives must register interest via the EU Funding & Tenders Portal by the EXA deadline. Submission is electronic (eSubmission). Full tender documents and details are available on the portal. Access requires signing in to the Funding & Tenders Portal.

Primary source:Tender Details. Regulation (EU) 2021/2282 ¹.

Footnotes

1. 1Additional resources: Implementing Regulation (EU) 2025/2086 on JCA procedures for medical devices Pharmavibes Summary.