Compliance requirements
The bidder must confirm that neither it nor members of its representative, management or supervisory bodies have been finally convicted within the last five years of participation in a criminal organisation, corruption, fraud, terrorism-related offences, money laundering, terrorist financing, illegal child labour or human trafficking offences. The exclusion grounds also cover significant tax or social security payment arrears, bankruptcy or insolvency proceedings, liquidation, suspended business activities, serious professional misconduct, anti-competitive agreements, conflicts of interest, improper involvement in preparing the procurement, serious breaches of previous public contracts, and the submission of false information or failure to provide required documents. The bidder or its representatives must also not be subject to national or international sanctions. The threshold for tax and social security payment obligations is EUR 0; however, the tax authority may not treat tax debt below EUR 100 or rescheduled tax debt as debt requiring a tax-debt certificate. Where an exclusion ground applies, the bidder may in certain circumstances provide evidence of remedial measures restoring its reliability.
Qualification criteria and exclusion grounds
The bidder must submit the participation declaration using Form II. In the case of a joint bid, a power of attorney for the joint bidders must be submitted using Form I, appointing an authorised representative. The proposed diagnostic products must comply with Regulation (EU) 2017/746 or its transitional provisions. The bid must include declarations of conformity and, where applicable, conformity certificates issued by a notified body. Where the transitional provisions apply, the bidder must also submit a declaration of conformity with Directive 98/79/EC and a manufacturer’s confirmation that compliance with Regulation (EU) 2017/746 will be ensured by the end of the transitional period. The bidder must confirm that the goods are not subject to international sanctions and do not originate from sanctioned regions. The bidder must also confirm that subcontractors or suppliers who are Russian citizens, residents or entities established in Russia, entities more than 50% owned by them, or entities acting under their control will not be used for more than 10% of the contract value. The bid must include the technical description in Annex 1, informative materials supporting the bid and the diagnostic product package inserts. The price must be submitted using the price form in Annex 2 and stated as the total four-year price excluding VAT in euros. The price must include all costs related to delivery and unloading at the joint laboratory of Tartu University Hospital at L. Puusepa 8, Tartu, and the quoted price is final. The machine-readable notice did not specify precise financial capacity, turnover, previous experience or team qualification requirements; any such requirements must be checked in the tender documents.