Compliance requirements
The exclusion grounds apply to all lots. Neither the bidder nor any member of its representative, management or supervisory body may have received a final conviction within the last five years for participation in a criminal organisation, corruption, fraud, terrorist offences or offences related to terrorist activity, money laundering or terrorist financing, illegal use of child labour, or human trafficking. Any exclusion period still in force also applies. Where permitted, the bidder may provide evidence of measures taken to restore its reliability.
A bidder may also be excluded for failing to meet tax or social security contribution obligations in Estonia or in its country of establishment. In Estonia, the tax authority does not issue a tax-debt certificate where the debt is below EUR 100 or payment has been deferred; tax debts of foreign bidders are dealt with under the law of their country of establishment. A contract must not be awarded if doing so would breach an international or Estonian government sanction. The bidder must provide a declaration on this point, and the contracting authority may request further information or evidence where it has reasonable grounds for doubt.
Qualification criteria and exclusion grounds
No specific financial-capacity, turnover, or previous-experience thresholds are stated in the provided documents. For each lot, the bidder must submit a technically compliant offer using the relevant technical offer annex (Annex 1 for Lot 1 and Annex 2 for Lot 2), and an application to participate using Form II. The bidder must hold the right to sell the offered products in Estonia and provide evidence from the manufacturer or, where the manufacturer is outside the European Union, its authorised representative; any further authorisations in the chain must also be documented. For jointly submitted bids, the joint bidders must appoint an authorised representative and submit the power of attorney in Form I. Conditional offers are not allowed, and submission confirms acceptance of the procurement-document requirements.
The offer must state the total price of one cochlear implant system in the specified price-form structure. The price must include delivery and unloading at the Tartu University Hospital Ear Clinic, including the equipment, hardware and software, and must be final with no additional charges. The bidder must provide manufacturer-issued user manuals for every item in the set in Estonian, Russian and/or English, maintenance instructions and plans, and a technical description with drawings. The products must bear CE marking and be lawfully marketed under Regulation (EU) 2017/745 or its transitional provisions; copies of declarations of conformity and, where applicable, EC certificates must be submitted, with the offered products clearly identified if the documents cover other products as well. The bidder must confirm that the offered goods are not subject to international sanctions and do not originate in sanctioned regions. Equivalent solutions may be offered where relevant, with an explanation and supporting evidence. The bidder must also confirm that subcontractors and suppliers representing more than 10% of the contract value are not Russian persons or entities, entities more than 50% owned by them, or persons acting on their behalf or instructions. Any claimed trade secrets must be identified and justified; the offer price and evaluable numerical information may not be designated as trade secrets.