Compliance requirements
The bidder must confirm the standard exclusion grounds, including no final conviction in the last five years for participation in a criminal organisation, corruption, fraud and other listed offences. If an exclusion ground exists, the bidder may provide evidence of self-cleaning, where allowed. The notice also requires confirmation that the offered goods are not subject to international sanctions and do not originate from sanctioned regions. In addition, the bidder must confirm that subcontractors or suppliers representing more than 10% of the contract value are not Russian nationals, residents, or entities established in the Russian Federation, are not more than 50% owned by such persons or entities, and do not act on their instructions.
Qualification criteria and exclusion grounds
The machine-readable notice did not include precise qualification criteria beyond the exclusion grounds and compliance requirements; these must be checked in the tender documents. The bidder must nevertheless confirm that the offer meets the tender documents, provide the required contact person details, submit the technical description form from Annex I, attach manufacturer technical documentation proving the product’s characteristics, and be ready to deliver one original-pack sterile instrument sample for testing within 5 working days after notice from the contracting authority. All offered products must have CE marking and comply with MDR 2017/745. If equivalence is relied on, the bidder must explain it and attach supporting evidence.