Compliance requirements
The bidder must confirm that neither it nor the members of its management body have been finally convicted within the last five years for participation in a criminal organisation, corruption, fraud, or any other exclusion ground listed in the tender documents. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures where permitted. The contract notice did not set out all exclusion grounds in full; they must be checked in the tender documents.
Qualification criteria and exclusion grounds
The bidder must have at least 1 person on the team who has received manufacturer training for servicing and repairing the devices covered by the tender. The bidder must provide details of that person, including their qualification and completed training. For the tendered device, the bidder must submit the technical compliance table, a short description of the offered configuration, the manufacturer’s and supplier’s exact warranty terms, the manufacturer’s technical maintenance requirements and recommendations, evidence that the device is a medical device and has passed conformity assessment under Directive 93/42/EEC or Regulation (EU) 2017/745 and bears the required CE certificate, technical documentation for the device and its main components/accessories, the user manual, and a price list for consumables/spare parts. The bidder must also provide confirmation from the manufacturer or the manufacturer’s authorised representative that the bidder is entitled to sell, provide warranty service and repair the offered devices in Estonia. If the bid is submitted by an authorised representative, a power of attorney must be attached. If the bid is a joint bid, a joint bidders’ power of attorney must be attached. The machine-readable notice did not include any more precise qualification or compliance requirements; the exact requirements must be checked in the tender documents.