Purchase of diagnostics and maintenance for Sysmex hematology analyzers

The bidder must confirm the standard exclusion grounds in the ESPD, including no final convictions in the last five years for participation in a criminal organisation, corruption, fraud and the other listed grounds in the tender documents. If an exclusion ground applies, the bidder may, where allowed, provide evidence of self-cleaning. The notice also requires confirmation that the offered goods are not subject to international sanctions and do not originate from sanctioned areas. In addition, the bidder must confirm that it does not involve, for more than 10% of the contract value, subcontractors or suppliers covered by the EU sanctions restrictions against Russian persons or entities. The exact exclusion grounds and confirmations must be checked in the official tender documents.

The bidder must have, in its company or working for it under another contractual basis, a representative for the offered diagnostics who has been trained by the manufacturer or has completed training for the diagnostics covered by the tender. The bidder must state the representative’s name in the ESPD and, if requested by the contracting authority, submit copies of certificates or the manufacturer’s written confirmation of the training. The bidder must also have at least two maintenance engineers/technicians trained by the manufacturer to service and repair the Sysmex XN-9100 analyzer line and the Sysmex SP-10 staining automaton. The bidder must provide their details in the ESPD and, if requested, submit copies of the training certificates or the manufacturer’s written confirmation. The bidder must have representation rights in Estonia for the offered diagnostics and consumables, and the right to provide maintenance and repair services for the listed equipment in Estonia. Supporting documents from the manufacturer, or from the manufacturer’s authorised representative if the manufacturer is outside the EU, must be submitted. If rights were further sub-authorised, the corresponding documents must also be provided. The bidder must submit the technical offer in the required form and confirm that the offer complies with the tender documents. The machine-readable notice also requires declarations of conformity for the diagnostics under Regulation (EU) 2017/746, or, where applicable, declarations under Directive 98/79/EC together with the manufacturer’s confirmation for the transition period. The exact technical and documentary requirements must be checked in the tender documents.