Compliance requirements
The bidder must confirm that no exclusion ground under Section 95(1) of the Public Procurement Act applies to it. The contracting authority will verify the absence of exclusion grounds before contract award, and supporting evidence must be provided if requested. If an exclusion ground exists, the bidder will be excluded from the procedure.
Qualification criteria and exclusion grounds
The bidder must be registered in a business or similar register in its country of establishment. If registration is not required by law, a copy of the incorporation agreement or an equivalent document must be provided. The bidder must be an official dealer of the offered equipment or its main components and must be able to provide technical support, including spare parts supply and repairs. The bid must include completed Annex 3 Form I with bidder details and confirmations, and, if necessary, a power of attorney. For the offered device, the bidder must submit a technical specification with actual parameter values, manufacturer information, a user manual and a short description of the configuration. The device must be a medical device, have undergone conformity assessment under Directive 93/42/EEC or Regulation (EU) 2017/745, and bear the CE mark; documents proving the risk class must also be submitted. The warranty must be at least 60 months, and exact manufacturer and supplier warranty terms plus technical maintenance requirements and recommendations must be provided. The contracting authority may request a sample, which must be delivered within 4 weeks. The bid validity period must be at least 3 months from the submission deadline. The price offer must be submitted on Annex 4 and must include delivery, installation, configuration and training. The bidder must also confirm that the bid complies with the tender documents, that equivalence has been explained where necessary, and that the offered goods are not subject to international sanctions and do not originate from sanctioned territories.