Purchase of a cardiotocograph

The bidder must confirm that none of the exclusion grounds listed in Section 95(1) of the Public Procurement Act apply to it. The contracting authority will check the absence of exclusion grounds before contract award, and the bidder may need to provide evidence if requested.

The bidder or a participant in a joint bid must be registered in the commercial or a similar register under the laws of its country of establishment. If there is no legal obligation to register, a copy of the founding agreement or an equivalent document must be submitted. The bidder must be the official reseller of the offered device in Estonia and submit the manufacturer’s original document or a copy proving this. The bid must include the bidder declaration in Annex 3 Form I with the required data and confirmations, and, if necessary, the power of attorney in Annex 3 Form II. The declaration must also confirm acceptance of all delivery and installation conditions set out in the tender documents and the contract. The bidder must submit the technical description of the offered device according to Annex 1 Table 1, including all actual parameter values. All numerical requirements must be given as numbers, and compliance must be evidenced with page references in the manufacturer’s information material. The manufacturer’s information material, user manual and a short description of the offered configuration, including separately purchased devices and hardware/software options, must also be provided. The bidder must submit documents proving that the device is a medical device, has undergone conformity assessment under Directive 93/42/EEC or Regulation (EU) 2017/745, and bears the required CE marking. A document showing the medical device risk class must also be submitted. The bidder must provide exact manufacturer and supplier warranty terms: at least 12 months for the device and at least 3 months for spare parts. In addition, the bidder must submit the manufacturer’s maintenance requirements and recommendations and a price list for reusable consumables according to Annex 4 Table 3 for the full contract period. The bidder must also submit the price list for repair works and repair call-outs according to Annex 4 Table 2, and the bid price form in Annex 4 Table 1. The bid price must include all costs related to delivery of the device to SA Pärnu Haigla, Ristiku 1, 80010 Pärnu. If requested by the contracting authority, a sample device must be delivered at the bidder’s own expense within four weeks. The bidder must also confirm that maintenance and repair will take place at the device location or at the manufacturer’s or the manufacturer’s approved partner’s premises, and that a free replacement device will be provided if the device remains in service for more than 2 days outside the contracting authority’s premises. The bid must include confirmation that it complies with the tender documents and, where relevant, an explanation of equivalence and supporting evidence. Conditional bids are not allowed.