Surgical consumable sets

The bidder and its representatives must confirm that no exclusion grounds apply. The checks cover, among other matters, participation in a criminal organisation, corruption, fraud, terrorist offences, money laundering or terrorist financing, and offences involving child labour or human trafficking. The bidder must also have no outstanding tax or social security payment obligations; a tax-debt certificate is not issued, among other cases, where the debt is below EUR 100 or payment has been deferred. Further exclusion grounds may include bankruptcy, insolvency or liquidation proceedings, an agreement with creditors, suspended business activities, serious professional misconduct, anti-competitive agreements, conflicts of interest, involvement in preparing the procurement or serious breaches of previous public contracts. False information, failure to provide required information or documents, and improper influence over the contracting authority's decision-making process may also lead to exclusion. The bidder must comply with applicable environmental, social and labour-law obligations and with national grounds concerning the employment of unlawfully present foreign nationals, international sanctions and tax offences. Where permitted by the contracting authority, the bidder may submit evidence of measures taken to restore its reliability. The bidder must confirm that the goods are not subject to international sanctions and do not originate from sanctioned regions. The bidder must also not involve, for more than 10% of the contract value, sanctioned Russian individuals or entities, entities controlled by them, or their subcontractors or suppliers.

The machine-readable procurement passport does not specify separate turnover, previous experience, staffing or other standalone qualification requirements. The bidder must submit a compliant tender, the participation application using Form 1 and, where necessary, an authorisation to represent the bidder using Form 2. The proposed products must comply with the technical specification in Annex 1 of the tender documents. The tender must include detailed technical descriptions and manufacturer-issued technical data in Estonian or English. The completed price tender form, Form 4, must also be submitted. One non-sterile sample set of every proposed product must be delivered at least one day before the tender opening deadline; late submission makes the tender non-compliant, and samples will not be returned. The bidder must have a locally based Estonian-speaking product representative. The products must have a valid type 1, 2 or 3 environmental label, supported by the licence number or relevant documentation. All products must bear a CE marking and comply with Medical Device Regulation MDR 2017/745. If an equivalent solution is offered, the bidder must explain the equivalence and provide supporting evidence. Conditional tenders are not allowed, and joint bidders must submit a joint-bidder authorisation.