Compliance requirements
The exclusion grounds mainly concern criminal convictions. The bidder, or a member of its management, representative or person with control rights, must not have a final conviction within the last 5 years for participation in a criminal organisation, corruption, fraud or other offences listed in the ESPD, if the exclusion period is still in force. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures, where permitted. The contracting authority also requires confirmation that, in performing the contract, the bidder will not use subcontractors or suppliers who are Russian citizens, entities established in the Russian Federation, or persons or entities linked to them, for more than 10% of the contract value, as described in the procurement documents.
Qualification criteria and exclusion grounds
The bidder must submit the tender in the form required by the procurement documents and confirm that the tender complies with all conditions. The tender must be prepared on the basis of the technical specification and the tender form, with all required fields completed. All offered products must bear the CE marking and comply with Medical Device Regulation MDR 2017/745. The bidder must provide the manufacturer’s technical documentation so that the contracting authority can verify the product characteristics and compliance. If requested, the bidder must be ready to provide one sterile instrument in original packaging for testing within 5 working days. The bidder must also provide contact person details: the name and position of the person signing the contract and the name, telephone number and email address of the contact person for contract performance. The tender price must be entered in the structure set out in the worksheet “Award criteria and evaluated indicators”. If the bidder relies on equivalence, it must explain this and attach supporting evidence. The machine-readable notice did not include precise qualification or suitability criteria; these must be checked in the procurement documents.