Compliance requirements
The bidder must confirm that neither it nor its management, supervisory or representative persons 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 ESPD. If an exclusion ground applies, the bidder may submit evidence of self-cleaning where permitted. The machine-readable notice did not include all precise exclusion grounds; they must be checked in the tender documents.
Qualification criteria and exclusion grounds
The bidder must have a product representative employed by the company or otherwise engaged under a contractual basis who has been trained by the manufacturer or has completed training for the diagnostics covered by the tender. The bidder must enter 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 the right to sell the offered diagnostics and consumables in Estonia and the right to provide maintenance and repair services for the Sysmex XN-9100, Sysmex SP-10 and the EIPU and Cellavision interface systems. The bidder must submit declarations of conformity under Regulation (EU) 2017/746 for the diagnostics or, if the products are on the market under the transitional provisions, a declaration of conformity to Directive 98/79/EC together with the manufacturer’s confirmation of compliance by the end of the transition period. The bid must comply with the technical specification, and Appendix 1 technical specification and Appendix 2 pricing form must be submitted. Details of the maintenance technicians must be provided in the ESPD; at least two manufacturer-trained maintenance engineers or technicians are required.