Compliance requirements
The contracting authority will exclude any bidder for whom an exclusion ground under Section 95(1) of the Estonian Public Procurement Act applies and will not conclude a contract with that bidder. The bidder must confirm that no exclusion ground applies. Before concluding the contract, the contracting authority will verify the successful bidder’s status and may require supporting evidence. The bidder must also confirm that the proposed goods are not subject to international sanctions and do not originate from a sanctioned region; otherwise, the bid may be rejected.
Qualification criteria and exclusion grounds
The bidder, or each entity participating in a joint bid, must be registered in a business or similar register in accordance with the laws of its country of establishment. If it is not legally required to register, the bidder must provide a copy of its founding agreement or an equivalent document. The bidder must be an official reseller of the proposed products and hold manufacturer-authorised rights to provide technical support in Estonia, demonstrated by an original manufacturer document or a copy.
The bidder must submit a participation statement with a bid validity period of at least three months from the bid submission deadline. If the person signing the bid does not have representation authority recorded in the relevant register, a power of attorney must be included. In a joint bid, the bidders must appoint an authorised representative and submit the relevant authorisation.
The bid must include a technical description showing the actual parameters of all devices, including numerical values, manufacturer information, user instructions and a description of the proposed configuration listing separately purchased equipment and hardware and software functions. Technical compliance must be demonstrated using manufacturer information, with page references in the compliance table. The devices must meet the minimum requirements in the tender documents, be medical devices authorised for use in the European Union and bear the required CE marking. Documents proving conformity assessment under Directive 93/42/EEC or Regulation (EU) 2017/745, as well as documents showing the risk class of the devices, must be submitted.
The manufacturer’s and supplier’s warranty must be at least 12 months. The bidder must provide the exact warranty terms and the manufacturer’s technical maintenance requirements, recommendations and description of maintenance work. At the time of bid submission, the bidder’s service team must include at least one service engineer who is proficient in spoken and written Estonian and has the skills and experience required to maintain and repair the proposed device.
If requested, the bidder must deliver a system sample to Pärnu Hospital at its own expense within four weeks of the contracting authority’s request. Failure to deliver the sample on time may result in rejection of the bid. The price offer must include all costs related to delivery, installation, configuration and training at Ristiku 1, 80010 Pärnu. Any trade secret must be identified and justified; the bid price and other required evaluation figures may not be classified as trade secrets. If an equivalent solution is offered, its equivalence and supporting evidence must be explained and included in the bid.