Tender detail

Purchase of immunoassay diagnostic reagents with testing capability

Summary

The contracting authority intends to conclude a framework agreement for the purchase of immunoassay diagnostic reagents, with the capability to perform analyses and service the necessary equipment. The procurement is divided into three lots: therapeutic drug monitoring, hormone and other immunoassays, and infectious-agent antibody testing. The supplier must provide the diagnostics and equipment needed for the analyses, together with installation, training, software, scheduled maintenance and repairs. Prices must be submitted for each lot on a five-year basis and include all costs specified in the tender documents. Bidders must submit the required technical and price offers, product compliance evidence, proof of sales representation rights and details of the required technical team.

Reference number
315918-0000
Buyer
sihtasutus Tartu Ülikooli Kliinikum
Country
Estonia (EST)
Procedure
Open procedure
CPV
33696500 Laboratory reagents
Deadline
2026-10-29
Status
Open
Contract subject
Supplies
Estimated value
Not published
Source
RHR

Participation requirements

Tender requirements are available in the official tender documents.

Compliance requirements

The bidder must declare whether it or its relevant representatives have final convictions within the previous five years for participation in a criminal organisation, corruption, fraud, terrorist offences, money laundering or terrorist financing, child labour or human trafficking. Exclusion grounds also cover unpaid taxes or social security contributions; bankruptcy, insolvency, liquidation, suspended business or similar situations; serious professional misconduct; agreements intended to distort competition; unmanageable conflicts of interest; involvement in preparing the procurement; serious or repeated breaches of previous contracts resulting in early termination, damages or comparable penalties; false or misleading information, failure to provide required information or documents, or attempts to obtain confidential information improperly. The bidder must also declare breaches of environmental, social or labour-law obligations, unlawful employment of foreign nationals, relevant tax offences and circumstances that would make contract award contrary to international sanctions. Where permitted, the bidder may provide evidence of remedial measures restoring its reliability. The stated tax-debt rules include an exception for debts below EUR 100 or debts whose payment has been rescheduled.

Qualification criteria and exclusion grounds

For all three lots, the bidder must have a product representative, employed or engaged under another contractual arrangement, who has been trained by the manufacturer or has completed training on the offered products. The bidder must also have at least two service engineers or technicians; at least one must have manufacturer training to maintain and repair the equipment needed for the analyses. If the second engineer is not yet trained, that person must be registered for the relevant training. The contracting authority may request training certificates, or, where training is pending, a manufacturer-approved training plan and proof of registration. The bidder must hold the right to represent and sell the offered products in Estonia and provide documentary evidence from the manufacturer or, where applicable, its authorised representative, including evidence of any onward authorisation. The offer must follow the technical specification and be supported by the manufacturer’s technical data and English-language instructions. Submit conformity declarations and, where applicable, notified-body certificates under Regulation (EU) 2017/746; for products placed on the market under its transitional provisions, submit the required declaration under Directive 98/79/EC and the manufacturer’s commitment to achieve compliance with Regulation (EU) 2017/746 by the end of the transition period. Submit the participation statement and the required technical and price forms; joint bidders must also provide an authorisation for their representative. Prices must be provided in the prescribed format for each lot for five years and include the specified diagnostics, consumables, equipment use, maintenance, software and updates, training for up to five contracting-authority employees per lot, delivery, installation and commissioning. The repair hourly rate must include all repair costs except spare parts. The bidder must confirm that the goods are not subject to international sanctions or from sanctioned regions and that it will not use, for more than 10% of the contract value, subcontractors or suppliers covered by the specified EU restrictions concerning Russia.