Compliance requirements
The tender documents include the standard exclusion grounds, including convictions for participation in a criminal organisation, corruption, fraud and other mandatory grounds under the Public Procurement Act. If an exclusion ground applies, the bidder may be allowed to show self-cleaning measures where the law or tender documents permit it. The machine-readable notice did not provide the full list in a compact form, so the exact exclusion grounds must be checked in the tender documents.
Qualification criteria and exclusion grounds
The bidder must be registered in the commercial register or another equivalent register in its country of establishment. If there is no registration obligation, a copy of the memorandum of association or an equivalent document must be submitted. The bidder must be the official distributor of the offered products in Estonia and must have manufacturer-authorised representation for technical support, spare parts supply, maintenance and repair; a manufacturer-issued original document or copy must be provided as evidence. The offered device must meet the requirements for a medical device, have undergone conformity assessment under Directive 93/42/EEC or Regulation (EU) 2017/745, and bear the CE mark. Documents showing the device’s risk class and electrical safety class must also be submitted. The device must comply with standards EVS-EN ISO 15883-1:2009/A1:2014 and EVS-EN ISO 15883-2:2009, and copies of the relevant certificates must be provided. The bidder must submit the technical specification with all actual parameter values, the manufacturer’s information material, the user manual, and a short description of the offered configuration. The bidder must confirm that the device is new and unused; at the time of handover, no more than 12 months may have passed since manufacture, and the device must not be a demo unit or refurbished. At the time of submitting the tender, the maintenance team must include at least one maintenance engineer in Estonia who speaks and writes Estonian and has received manufacturer training for servicing and repairing the device; a copy of the training certificate must be submitted. In addition, the bidder must submit the manufacturer’s and supplier’s warranty terms, under which the device warranty must be at least 12 months and the spare parts warranty at least 6 months, the manufacturer’s maintenance requirements and recommendations, the maintenance service price list, and the repair and call-out price list for the entire framework agreement period. In the case of a joint tender, an authorised representative must be appointed and a power of attorney must be submitted. The tenderer’s declaration form must be submitted together with the required confirmations, and the tender validity period must be at least 3 months from the tender submission deadline. The machine-readable notice did not provide any more precise qualification requirements, so the official tender documents should be checked for full details.