HbA1c and HbA0 purified

This document presents a pre-information notice regarding a forthcoming procurement opportunity by the European Commission's Joint Research Centre (DG JRC). The purpose of this procurement is to secure purified human Hemoglobin A1c (HbA1c) and Hemoglobin A0 (HbA0) in a stabilizing buffer. The intended use of these materials is to create candidate certified reference materials (CRM) that will replace the previous CRM ERM-AD500/IFCC. These CRMs are essential for clinical chemistry and align with the requirements set forth by EU Regulation 2017/746 concerning in vitro diagnostic medical devices.

The procedure is classified as a planned negotiated procurement contract, specifically a middle to low value contract, with a maximum duration of six months. Important milestones include the start of the expression of interest on July 2, 2025, and a deadline for expressions of interest by July 11, 2025, with the contract launch tentatively scheduled for July 4, 2025. Interested parties are required to submit their electronic expressions of interest.

Eligible applicants for this procurement include any economic operators capable of supplying the necessary materials, with no explicit restrictions mentioned in the tender documentation. The target sector for this procurement falls under clinical diagnostics, specifically materials needed for creating reference standards. Geographic eligibility appears open internationally, given that it is an EU procurement procedure, though entities from EU and EEA countries are likely prioritized.

Details on the funding amount remain unspecified, and the nature of support provided will involve monetary compensation for the supplied goods. Since this is a procurement contract and not a grant, there is no co-funding requirement or declared success rates, as outcomes will depend on competitive bidding processes. The application procedures feature a single stage focused on electronic submissions.

Overall, this notice represents a preliminary announcement rather than a call for tenders. The JRC aims to fulfill its requirements for high-quality, traceable reference materials, vital for ongoing research and diagnostics in the healthcare sector.

This is a pre-information notice, announcing the European Commission, DG JRC Joint Research Centre's intention to publish a future negotiated low or middle value procedure. This is NOT a call for tenders. The procedure identifier is EC-JRC/GEE/2025/MVP/3139-EXA.

The procedure concerns the procurement of purified human HbA1C and HbA0 in stabilizing buffer (containing at least 50 mmol/L MES, 10 mmol/L KCN, 1 or 2 mmol/L Na2EDTA, pH 6.2, additional additives are allowed to be present as well ), subdivided in aliquots.

The objective of the project is the production of candidate certified reference materials (CRM) for HbA0 and HbA1c that will replace the previous CRM ERM-AD500/IFCC. JRC will produce the candidate CRM by mixing solutions of highly purified human HbA1c and HbA0. The final material will consist of a set of 6 solutions with different amount-of-substance fractions of HbA1c and it will be evaluated by the IFCC network of HbA1c Reference Method Laboratories. The production of these reference materials is of crucial importance in clinical chemistry, driven by the EU Regulation on in vitro diagnostic medical devices (IVD-MD) (Regulation (EU) 2017/746), which requires traceability of calibrants and control materials.

The procedure type is a planned negotiated procedure for a middle/low value contract. The nature of the contract is supplies. The maximum contract duration is 6 months. No framework agreement is mentioned.

Milestones:
Start date for expression of interest: 2025-07-02 Europe/Brussels
Deadline for expression of interest: 11/07/2025 04:59 Europe/Brussels
Indicative date of launch of the negotiated procedure: 2025-07-04 Europe/Brussels

The method of expression of interest is electronic. Submissions must be sent exclusively at the address for submission given below.

The main classification (CPV) code is 33141510 Blood products.

A question was asked: Where can I find the procurement documents for calls for tenders with ‘ExA' in the reference? The answer provided was: References that feature an ‘ExA’ are not calls for tenders. They are a publication announcing the contracting authority’s intent to launch in the future a low or middle negotiated procedure. This answer was published on 03/10/2024 16:32.

In summary, this is a pre-information notice from the European Commission's Joint Research Centre (JRC) about a future procurement opportunity. The JRC plans to launch a negotiated procedure to procure purified human HbA1C and HbA0 in a stabilizing buffer, which will be used to produce candidate certified reference materials (CRMs) for HbA0 and HbA1c. These CRMs are essential for clinical chemistry and are driven by the EU Regulation on in vitro diagnostic medical devices (IVD-MD). The contract is for supplies, with a maximum duration of 6 months. The expression of interest period starts on July 2, 2025, and ends on July 11, 2025. The negotiated procedure is expected to launch on July 4, 2025. This notice is not a call for tenders, but rather an announcement of the JRC's intention to launch a negotiated procedure in the future.

Eligible Applicant Types: The eligible applicant types are not explicitly stated in the provided text. However, given the nature of the procurement which involves supplying purified human HbA1C and HbA0, it can be inferred that eligible applicants would likely include companies, research institutions, or other organizations specializing in the production and supply of biochemicals, blood products, or reference materials for clinical chemistry.

Funding Type: This is a procurement opportunity, specifically a planned negotiated procedure for a middle/low value contract. The nature of the contract is for supplies.

Consortium Requirement: The text does not explicitly state whether a single applicant or a consortium is required. Given that it is a procurement for supplies, it is more likely that single applicants are eligible, although consortia that can fulfill the requirements might also be considered.

Beneficiary Scope (Geographic Eligibility): The geographic eligibility is not explicitly mentioned. However, since it is an EU funding opportunity from the European Commission, it is highly likely that entities from the EU and possibly EEA countries are eligible. Further details would need to be checked in the full call for tenders when it is published.

Target Sector: The target sector is clinical chemistry and in vitro diagnostics, specifically related to the production and certification of reference materials for HbA0 and HbA1c. This falls under the broader categories of health, biotech/medtech, and possibly pharma/healthcare.

Mentioned Countries: No specific countries are mentioned. The relevant region is the EU, as the contracting authority is the European Commission, DG JRC Joint Research Centre.

Project Stage: The project stage is related to the supply of purified materials, which suggests a commercialization or production stage. The materials will be used for the production of candidate certified reference materials (CRM).

Funding Amount: The opportunity is described as a "middle/low value contract," but the estimated total value is not specified. This suggests the funding amount is likely under €200k, but without further information, a more precise range cannot be determined.

Application Type: The application type is a planned negotiated procedure. This means that after the expression of interest, selected applicants will be invited to negotiate a contract.

Nature of Support: The beneficiaries will receive money in exchange for supplying the purified human HbA1C and HbA0. Therefore, the nature of support is monetary.

Application Stages: The application process involves at least two stages: an expression of interest and a subsequent negotiated procedure for selected applicants. Therefore, there are at least 2 stages.

Success Rates: The success rates cannot be determined from the provided text, as this is just an announcement of a planned procedure.

Co-funding Requirement: The text does not mention any co-funding requirement.

Summary:

This is a pre-announcement of a planned negotiated procurement procedure by the European Commission, DG JRC Joint Research Centre, for the supply of purified human HbA1C and HbA0 in stabilizing buffer. The purpose of this procurement is to obtain materials needed for the production of candidate certified reference materials (CRM) for HbA0 and HbA1c, which are crucial for clinical chemistry and driven by the EU Regulation on in vitro diagnostic medical devices (IVD-MD). The procedure is classified as a middle/low value contract, and the maximum contract duration is 6 months. The start date for expression of interest is planned for July 2, 2025, with a deadline of July 11, 2025. The indicative date for the launch of the negotiated procedure is July 4, 2025. Interested parties must submit an electronic expression of interest. This announcement is not a call for tenders, but rather a notification of the contracting authority's intention to launch a negotiated procedure in the future.