Compliance requirements
The bidder must confirm that none of the exclusion grounds set out in section 95(1) of the Estonian Public Procurement Act apply to it. Before concluding the framework agreement, the contracting authority will check the successful bidder’s status using public databases. If requested, the successful bidder must provide evidence that these exclusion grounds do not apply before the contract is concluded.
Qualification criteria and exclusion grounds
No separate financial-capacity, experience or personnel qualification thresholds are specified. The bid must be unconditional and comply with the tender documents. The bidder must provide the requested contact details for the person authorised to sign the contract (including the basis of authority and, where applicable, a power of attorney) and for the contract contact person, as well as submit the price in the prescribed structure and complete Annex I, the technical description and bid form. All offered products must bear the CE marking and comply with Medical Devices Regulation (EU) 2017/745. The bidder must provide manufacturer-issued technical documentation supporting the stated product characteristics and compliance.
If requested by the contracting authority, the bidder must deliver one sterile instrument in its original packaging for testing within 5 working days of receiving the request; the deadline may be extended by agreement. The sealed, marked sample must identify the procurement, reference number and bidder and be delivered to H-building, Ravi 18, Tallinn. The sample will be tested and used to assess suitability; the bid may be rejected if the sample is late, fails the technical description or stated use technology, or has technical problems in use. Samples submitted become part of the bid and will not be returned. The authority may order additional samples for compliance checks. These will be paid for at the offered unit price, but the goods will be returned without payment if the order is not completed in full, is late, contains fewer items than ordered or has product codes that differ from the bid. Such orders must be fulfilled within 5 working days.
The bidder must identify and justify any claimed trade secrets; prices and other specified evaluation-related figures or characteristics may not be classified as trade secrets. Where equivalence is relevant, the bidder must explain it and provide supporting evidence; acceptable alternative evidence may be used where the bidder demonstrates compliance with the stated requirements. The bidder must confirm that the offered goods are not subject to international sanctions and do not originate in sanctioned regions. It must also confirm that it will not involve, for more than 10% of the contract value, subcontractors or suppliers that are Russian nationals, residents or entities established in Russia, are more than 50% directly or indirectly owned by such persons or entities, or act on their behalf or under their direction. No award-scoring method is specified in the supplied document.