Capacity Reservation for Personal Protective Equipment Pilot

HaDEA has launched an EU4Health public tender (HADEA/2026/OP/0020) to reserve manufacturing capacity and establish contractor‑managed stockpiles for nitrile examination gloves (Lot 1) and FFP2 respiratory masks (Lot 2). Contracts will run up to 36 months, each lot may be awarded to up to three tenderers, and the indicative total procedure value is €34,000,000. Eligible tenderers are manufacturers with production capacity in the EU/EEA able to manage stockpiles and guarantee priority purchase rights for the contracting authority or the European Commission. Submission is via the EU Funding & Tenders Portal with a deadline of 15 October 2026 at 12:00 CEST.

Call type and reference

Tender HADEA/2026/OP/0020 — EU FAB+ PPE Pilot

What it funds:contracts to reserve manufacturing capacity and to set up contractor-managed stockpiles of nitrile examination gloves (Lot 1) and FFP2 respiratory masks without exhalation valves (Lot 2). The Commission/contracting authority has a priority right to purchase stockpiled or manufactured items for preparedness or crisis use.

Who can apply:Manufacturers with production capacity located in the EU/EEA able to create and manage stockpiles and to guarantee priority purchase rights; awards limited to a maximum of three tenderers per lot.

1. 1Scope: Lot 1 nitrile examination gloves; Lot 2 FFP2 masks (compliant with relevant EN standards).
2. 2Contract duration: up to 36 months per contract; each lot awarded to up to three suppliers.

Key dates:submission deadline 15 October 2026 (12:00:59 Brussels time). An earlier date (01 January 2026) appears in metadata; consult tender documents for clarifications.

Lead contracting authority:Health and Digital Executive Agency (HaDEA). Submission via the EU Funding & Tenders Portal eSubmission procedure. ¹

Footnotes

1. 1Tender details and documents: EU Funding & Tenders Portal.

Opportunity summary

This is a call for tenders issued by the Health and Digital Executive Agency (HaDEA) and the European Commission to conclude contracts for reservation of manufacturing capacity and contractor-managed stockpiles for essential Personal Protective Equipment (PPE). The pilot covers two separate lots: Lot 1 Nitrile examination gloves and Lot 2 FFP2 respiratory masks (EU FAB+ PPE Pilot). Contracts awarded under each lot will be for up to 36 months (3 years) and each lot may be awarded to a maximum of three tenderers. The contractor must be established and have manufacturing capacity in the EU/EEA and be able to create and manage stockpiles with an associated priority right for the contracting authority and/or the European Commission to purchase the stockpiled or manufactured Medical Counter-Measures (MCMs) when needed for preparedness or crisis response. Purchased items must be replenished in stockpile or trigger an equivalent reservation of manufacturing capacity for the remainder of the contract. Procurement of items under the contracts, if required, will be executed by the contracting authority and/or the European Commission via a separate purchasing procedure on behalf of EU/EEA countries or EU4Health associated countries.

Key dates:Deadline for submission: 15 October 2026 at 12:00:59 (Europe/Brussels). Additional earlier internal dates: 1 January 2026 10:00:59 (appears in metadata). Open tender event (clarification/remote event) scheduled 15 October 2026 at 15:00 (CEST). Last date to request additional information: 7 October 2026. Tender validity period required: 6 months from submission. ¹

Estimated contract value and duration:Estimated overall procedure value: €34,000,000. Estimated overall contract amount per lot: €17,000,000. Planned contract duration per awarded contract: 36 months (3 years).

Detailed scope and technical requirements

Scope:reservation of manufacturing capacity and establishment of contractor-managed stockpiles for nitrile examination gloves (Lot 1) and FFP2 respiratory masks (Lot 2). The contracting authority and/or the European Commission retain a right to activate purchase of the stockpiled or manufactured MCMs for preparedness or crisis purposes. Purchases must be replenished or produce an equivalent reserved manufacturing capacity for the remainder of the contract. Each lot may be awarded to up to three tenderers. Purchase of products under the framework will be carried out in separate purchasing procedures and may be performed on behalf of any EU/EEA country or any EU4Health associated country.

Technical product standards requirements (as specified in tender documents):

1. 1Lot 1 Nitrile examination gloves: must comply with EN ISO 21420, EN 455 (parts 1 to 4) and EN 374-1 type C, EN 374-4 and EN 374-5; must have valid CE marking.
2. 2Lot 2 FFP2 respiratory masks: must comply with EN 149:2001+A1:2009; must have valid CE marking; must not have an exhalation valve; must not rely on ear loops; securing the mask shall rely on straps around the head and/or neck to provide a good seal with the user’s face.

Eligibility and applicant requirements

Eligible applicants must be economic operators (tenderers) with manufacturing capacity in the EU/EEA. Tenderers must demonstrate they can set up and manage stockpiles and provide the priority right to the contracting authority/European Commission to purchase stockpiled or manufactured items. Tenderers must submit evidence of conformity with the required product standards and valid CE marking where applicable. Specific selection and qualification criteria are set out in the procurement documents (tender specifications and annexes) and must be consulted by tenderers.

1. 1Eligible Applicant Types: manufacturing companies with production capacity in the EU/EEA, including SMEs and large enterprises. The procurement is targeted at entities capable of running contractor-managed stockpiles and fulfilling manufacturing reservation obligations. (Research institutes, universities or pure service providers are not the primary target unless they have manufacturing capacity.)
2. 2Consortium Allowed/Requirement: The procurement is framed as a tender for single contractors per contract. The procurement documents include specific tenderer qualification requests and may permit or define the structure for subcontracting or consortium arrangements; however the procurement metadata and draft contract indicate contracts will be concluded with tenderers (single legal entities). Tenderers should consult the tender specifications for rules on joint bids or use of subcontractors.
3. 3Geographic Eligibility: Tenderers must have manufacturing capacity located in the EU/EEA (European Union and European Economic Area). Purchases may be made on behalf of EU/EEA countries or EU4Health associated countries.
4. 4Applicant legal and administrative requirements: standard procurement declaration of honour and financial offer forms are provided in the tender dossier. Tenderers must supply the requested procurement documentation and satisfy the selection criteria (financial, technical, legal) described in the tender specifications and annexes.

Award criteria and evaluation

Award criteria are quality and price. The weight indicated in the procurement metadata is 60 for quality and 40 for price, but tenderers must consult the procurement documents for the full description and sub-criteria applied to quality and price assessment. Evaluation will be performed following the rules and scoring mechanisms set in the tender specifications and the draft contract.

Tenderers must complete the provided financial offer forms (Annex 6.1 for Lot 1, Annex 6.2 for Lot 2) and may review an example financial offer form (Annex 6.3 example). A draft contract and contract appendix are provided in the dossier for bidders to understand contractual terms.

Submission, procedure and documents

Submission method:electronic submission via the EU Funding & Tenders Portal (eSubmission). Tender documentation and all annexes are published with the call (invitation to tender, tender specifications including annexes, draft contract and appendices, declaration on honour, and financial offer forms). Tenderers must follow the eSubmission requirements and upload signed declarations and the financial and technical offers in the formats requested.

1. 1Application Type: open call (call for tenders) with published documentation and eSubmission. Submission required by the deadline published.
2. 2Number of submission stages: Single-stage submission of tenders (submission of qualification, technical and financial offers in one procedure). There is an open tender event and clarifications period; purchasing of products will follow under separate procedures if options are exercised.
3. 3Tender validity period: tenders must remain valid for at least 6 months from the submission deadline (as specified).

Funding type, nature of support and co-funding

Funding Type:This is a procurement/ tender for services and reserved capacity rather than a grant. The contracting authority will enter into service contracts for capacity reservation and stockpile management. The estimated total procedure value is €34,000,000 (budgetary estimate) and the estimated value per lot is €17,000,000. Nature of support: contracts will result in monetary payments by the contracting authority to contractors under the terms of the awarded contracts (service contract / procurement payment), and the contracting authority/European Commission obtains rights to priority purchase. Co-funding: No co-funding by tenderers is described in the procurement metadata; contractors will be paid under the contract terms. Tenderers should consult the contract and tender specifications for any financial guarantees, performance securities, or advance payment rules. The procurement is EU-funded and classified under eu-funds funding program codes.

Selection and award process specifics

Consortium requirement and subcontracting:The procurement documents include specific tenderer qualification requirements and may allow joint bids or subcontracting in line with procurement rules, but the contractual documentation is designed to conclude contracts with tenderers who will take primary responsibility. Tenderers should carefully read the tender specifications and draft contract to understand permitted use of subcontractors and requirements for demonstrating manufacturing capacity in the EU/EEA. Award will be to a maximum of three tenderers per lot; each awarded contract will be individually implemented for up to 36 months.

Success rates:Not published. As an open tender with a limited number of awards per lot (max three), success depends on competition, compliance with requirements, and scoring against quality and price criteria. No explicit historical success rate is provided in the procurement notice.

Application templates and documents provided

The tender dossier (published 22 July 2026) contains the following principal documents (examples of filenames shown in the procurement metadata):

• Invitation to tender (1.HADEA2026OP0020 - Invitation to tender_V1.pdf)
• Tender specifications (3.1 HADEA2026OP0020 - Tender specifications_V1.pdf and Annex 8 and Annex 9 docx/pdf files)
• Draft contract (2.1 HaDEA2026OP0020 - Draft contract_V1.pdf) and draft contract appendix (2.2 HaDEA2026OP0020 - Draft contract - Appendix 1_V1.pdf)
• Declaration on honour - Annex 2 (4. HADEA2026OP0020 - Declaration of honour - Annex 2_V1.docx)
• Financial offer forms: 5.1 HADEA2026OP0020 - Financial offer form - Lot 1 - Annex 6.1.xlsx; 5.2 HADEA2026OP0020 - Financial offer form - Lot 2 - Annex 6.2.xlsx; 5.3 example financial offer form (PDF)
• Tender specifications annexes detailing technical, legal and contractual requirements (Annex 8 and Annex 9).

Template structure and how to fill:The procurement package provides specific templates for the financial offer (Excel forms per lot) and a declaration of honour. Tenderers must complete the financial offer form for their chosen lot, supply required supporting evidence for technical and conformity claims (CE certificates, test reports, production capacity documentation), and fill in the declaration of honour and other administrative forms. Tenderers must also ensure compliance with the draft contract terms and be prepared to accept the priority purchase and replenishment/reservation obligations under the contract. Exact fields, required annexes and submission formats are specified in the tender specifications and the annexed financial forms.

Procurement classification and CPV codes

Main CPV codes referenced in the procurement metadata:63120000 (Safety clothing) is the main classification. Additional CPV code: 33100000 (Medical and surgical equipment).

Benefitting zones and contracting authority

Lead contracting authority:Health and Digital Executive Agency (HaDEA). Benefitting zones: EU/EEA countries and EU4Health associated countries may benefit since purchases can be made on their behalf by the contracting authority/European Commission.

Answers to required classification questions

1. 1Eligible Applicant Types: Manufacturing companies with production capacity in the EU/EEA, including SMEs and large enterprises; entities able to manage stockpiles and fulfil procurement contractual obligations. Research institutes or universities only if they operate qualifying manufacturing facilities or act within permitted bidder structures. Nonprofits and governments are not the primary addressees unless functioning as manufacturers.
2. 2Funding Type: Procurement / service contract (tender). This is not a grant or loan. The mechanism is a public procurement for reservation of capacity and stockpile management with payment under a contract.
3. 3Consortium Requirement: Not explicitly required as a consortium; procurement is structured to conclude contracts with tenderers (single contracting legal entities). The tender specifications should be consulted for joint tender rules and subcontracting provisions; consortium/joint bids may be possible if allowed but are not mandated.
4. 4Beneficiary Scope (Geographic Eligibility): Tenderers must have manufacturing capacity in the EU/EEA. Purchases may be executed on behalf of EU/EEA countries or EU4Health associated countries.
5. 5Target Sector: Health / medical supplies / personal protective equipment; specifically medical PPE and medical counter-measures.
6. 6Mentioned Countries: EU and EEA (European Union and European Economic Area) and EU4Health associated countries (region-level references). No individual Member States are named in the notice.
7. 7Project Stage: Operational production and preparedness (production, stockpiling, supply readiness). Expected maturity: manufacturing and commercial production capacity, stockpile management and operational readiness (demonstration/implementation stage rather than pure research).
8. 8Funding Amount: Estimated total procedure value €34,000,000; estimated €17,000,000 per lot (indicative). Each lot may be awarded to up to three tenderers; the individual contract value will depend on awarded shares and financial offers.
9. 9Application Type: Open call for tenders published on the EU Funding & Tenders Portal with eSubmission required; closing date 15 October 2026.
10. 10Nature of Support: Monetary contracts (payments under service/procurement contracts) and operational obligations (non-monetary: requirement to create and manage stockpiles and reserve manufacturing capacity).
11. 11Application Stages: Single main submission stage for tender (submit qualification, technical and financial documentation), plus clarification period and potential negotiation/post-award contracting stage. Overall applicants pass through 1 primary submission stage and post-award contractual implementation stages.
12. 12Success Rates: Not specified. As each lot will be awarded to a maximum of three tenderers, competition level will determine success probability. No historical success rate provided.
13. 13Co-funding Requirement: Not described as required. Tenderers are paid under procurement contracts; however performance securities or guarantees may be required per draft contract. Tenderers must consult tender specifications for financial guarantees or liability clauses.

How to apply and next steps

Steps for interested tenderers:download the full tender dossier and annexes from the EU Funding & Tenders Portal; verify eligibility (manufacturing capacity in EU/EEA); prepare technical documentation proving product conformity (CE certificates, test reports to the mentioned EN standards), production capacity evidence, stockpile management capability, and financial offer using the provided Excel templates; complete the declaration on honour and any other administrative forms; submit all documents via eSubmission on the portal before 15 October 2026 12:00:59 (Brussels time). Attend or monitor the open tender event on 15 October 2026 and use the clarification period ending 7 October 2026 to request clarifications.

Procurement documents and templates are available in the tender dossier published 22 July 2026 on the EU Funding & Tenders Portal, including the draft contract, tender specifications (Annex 8 and Annex 9), financial offer forms for Lot 1 and Lot 2, declaration on honour, and example financial form. Tenderers must consult these documents for full legal, technical and administrative requirements. ¹

Comprehensive summary

This procurement seeks to pre-position production capacity and contractor-managed stockpiles of two PPE categories (nitrile examination gloves and FFP2 masks) to strengthen the EU/EEA preparedness for health emergencies. It is a public tender (procurement) managed by HaDEA on behalf of the European Commission. The contracts are service contracts combining capacity reservation and stockpile management obligations, with the contracting authority/Commission holding purchase activation rights for preparedness or crisis needs. Tenderers must be manufacturers with production capacity within the EU/EEA and demonstrate compliance with specified EN standards and CE marking. The procurement is estimated at €34 million in total, split roughly €17 million per lot, with awards to up to three suppliers per lot. Submission is electronic via the Funding & Tenders Portal, deadline 15 October 2026. Tenderers must use the provided financial offer templates, deliver technical evidence of product conformity and production/stockpile capability, and comply with the draft contract obligations including replenishment or reservation of equivalent manufacturing capacity when purchases are activated.

Footnotes

1. 1Tender dossier and submission portal: Capacity Reservation for Personal Protective Equipment Pilot - Tender details on the EU Funding & Tenders Portal (HADEA/2026/OP/0020). Available at Tender notice.

This is a HaDEA EU4Health tender for reservation of manufacturing capacity and managed stockpiles for nitrile examination gloves and FFP2 respiratory masks, not a grant award.[1][3]

What the tender covers

The call aims to improve the accessibility and availability of medical countermeasures in the EU and EEA by concluding contracts for two lots: lot 1 for nitrile examination gloves and lot 2 for FFP2 respiratory masks.[1][3]

The selected contractor is expected to maintain contractor-managed stockpiles and an associated priority right for the contracting authority or the European Commission to purchase the products when needed for preparedness or crisis purposes.[1][3]

If stockpiled products are purchased, they must either be replenished in the stockpile or be replaced by an equivalent reservation of manufacturing capacity for the remainder of the contract.[1]

Who can apply

The opportunity is aimed at tenderers with manufacturing capacity in the EU or EEA, and the description also implies the ability to manage stockpiles for the products in scope.[1][3]

The supplied results do not show the full exclusion, selection, or documentation requirements, so applicants should verify the tender specifications in the portal before submitting.

Commercial terms and award structure

• Each lot will be awarded to a maximum of three tenderers.[1][3]
• Each contract will last 3 years, or 36 months.[1][3]
• Purchases of the actual products will be made separately by the contracting authority or the European Commission, including on behalf of EU or EEA countries or EU4Health associated countries.[1]
• The tender is therefore a capacity reservation and stockpiling arrangement rather than a direct supply contract for immediate delivery.[1][3]

Budget and timeline

The metadata supplied with the query also contains a 1 January 2026 timestamp, but that is inconsistent with the published call information and should not be treated as authoritative ¹.

What applicants should watch carefully

Because the action relies on reserved capacity and stockpile management, applicants should be prepared to demonstrate production capability, supply chain control, and the operational ability to activate or replenish stock on demand.[1][3]

The source material does not provide the detailed award criteria, financial guarantees, or technical minimums, so those points should be checked in the tender specifications before bid preparation.[1]

Footnotes

1. 1The HaDEA notice published on 22 July 2026 states that interested parties are invited to apply via the EU Funding and Tenders Portal by 15 October 2026, 12.00 CEST.[1]