Compliance requirements
The bidder must confirm the standard exclusion grounds: participation in a criminal organisation, corruption, fraud, and the other grounds listed in the ESPD under Section 95 of the Estonian Public Procurement Act. If any such ground applies, the bidder must provide the answers, the date of conviction, the reason, the person convicted, the duration of exclusion if stated in the judgment, and information on any self-cleaning measures. The tender documents also require confirmations that the offered goods are not subject to international sanctions and that subcontractors or suppliers linked to the Russian Federation do not account for more than 10% of the contract value. If the exact content or evidence is not fully visible in the machine-readable notice, it must be checked in the tender documents.
Qualification criteria and exclusion grounds
The bidder must submit an offer that complies with the technical requirements in Annex 1 and must include the manufacturer’s technical data sheet and/or user manual so that the contracting authority can verify compliance. The bidder must also submit maintenance plans for the warranty period and the post-warranty period, showing the frequency of routine maintenance, the work to be performed and the time required. The bidder must have the right, granted by the manufacturer or the manufacturer’s authorised representative, to sell and service the offered device; where applicable, documents on sub-authorisation must be provided. The offered devices must bear the CE marking and comply with Regulation (EU) 2017/745 or have a Medicines Agency use authorisation for the entire service life of the device; declarations of conformity, where applicable certificates of conformity, or the use authorisation must be submitted. As to technical capacity, the bidder must have, throughout the entire contract performance period, a maintenance engineer or maintenance technician who has received manufacturer training for installation, commissioning, maintenance and repair of the device, as well as a person trained by the manufacturer’s factory to deliver the training referred to in point 4.1 of Annex 1. Details of these persons and copies of the training certificates must be provided in the ESPD and with the tender.