Compliance requirements
The bidder must confirm that neither the bidder nor its management, administrative or supervisory body members have been finally convicted within the last five years for participation in a criminal organisation, corruption, fraud, or other exclusion grounds named in the tender documents. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures where permitted.
The bidder must confirm that the offered goods are not subject to international sanctions and do not originate from sanctioned regions.
The bidder must also confirm that it will not use subcontractors or suppliers representing more than 10% of the contract value who are Russian nationals, Russian residents, entities established in the Russian Federation, entities more than 50% owned by such persons or entities, or representatives acting on their instructions.
The machine-readable notice did not set out the full list of exclusion grounds; the exact list must be checked in the tender documents.
Qualification criteria and exclusion grounds
The bidder must have, in its company or under another contractual arrangement, a product representative for the offered diagnostics who has been trained by the manufacturer or has completed training for the products covered by the tender. The bidder must state the representative’s name in the ESPD and, on request, provide copies of training certificates or the manufacturer’s written confirmation.
The bidder must also have at least two maintenance engineers or technicians who have received manufacturer training for maintaining and repairing the equipment needed to perform the analyses. The bidder must provide the details of these technicians, including their place of work, in the ESPD and, on request, copies of training certificates or the manufacturer’s written confirmation.
The bid must include conformity declarations for the equipment and diagnostics, and where applicable conformity certificates. If the products are on the market under transitional provisions, the bidder must also submit a declaration of conformity to Directive 98/79/EC and the manufacturer’s confirmation that compliance with Regulation (EU) 2017/746 will be ensured by the end of the transition period.
The bidder must have the right to represent and sell the offered equipment and diagnostics in Estonia. This must be proven by a document from the manufacturer or, if the manufacturer is outside the EU, from the manufacturer’s authorised representative, and any further sub-delegation documents if relevant.
The bid must include a technically compliant offer, the manufacturer’s English technical datasheet and user manual, the analyser LIS connection guide, the English analyser user manual, the English methodological instructions for the analyses, and the regular maintenance plan for the analysers. A maintenance schedule for the full period purchased must also be provided, together with a description of the maintenance procedures.