Compliance requirements
The tender documents include the standard exclusion grounds. The bidder must confirm that none of the mandatory exclusion grounds apply, including participation in a criminal organisation, corruption, fraud and the other grounds listed in the ESPD. If an exclusion ground applies, the bidder may have to provide details and evidence of self-cleaning, where allowed by the procurement documents.
Qualification criteria and exclusion grounds
The bidder must be registered in the commercial register or an equivalent register in its country of establishment. If registration is not required by law, a copy of the founding document or an equivalent document must be provided.
The bidder must hold the activity licences needed to perform the framework agreement, including a radiation activity licence. In a joint tender, a valid licence is required for all legal entities that will supply, install, maintain or repair the equipment.
The bidder's net turnover for the last three completed financial years must be at least EUR 2,000,000. If the bidder relies on the resources of another entity, it must prove that the necessary resources are available for performance of the framework agreement and can be used when needed. If applicable, Appendix 5 Form II must also be submitted when other entities participate directly in performance.
The bid must include the bidder declaration in Appendix 3 Form I with the required data, confirmations and a bid validity period of at least 3 months from the deadline for submission of tenders. If the signatory does not have representation rights in the register, a power of attorney must be submitted.
The bidder must submit the technical description of the offered device according to Appendix 1 Tables 1, 2 and 3, with the actual values of all parameters, as well as the manufacturer's information material and user manual. A short description of the configuration, the manufacturers' trade names and exact model names, and a list with prices of all additional functionalities that can be purchased later must also be provided.
The bidder must submit the CE certificate and declaration of conformity proving that all offered devices except the UPS are medical devices, have undergone conformity assessment under Directive 93/42/EEC or Regulation (EU) 2017/745, and bear the required CE marking. Documents showing the risk class and electrical safety class of the devices must also be submitted.
The bidder must submit the manufacturer's and supplier's warranty terms. The warranty for the device and additional functionalities must be at least 12 months, and the warranty for spare parts at least 6 months. In addition, the bidder must provide the manufacturer's technical maintenance requirements and recommendations, the maintenance price list, the repair and call-out price list, and the price list for additional functionalities. The price lists must remain valid for the entire framework agreement period or for at least three years from signature, as required.