Intraocular injection preparation and administration kit

The bidder must confirm that neither it nor the members of its management, administrative or supervisory bodies have been finally convicted in 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 measures where permitted. The ESPD also requires confirmation of tax and social security payment information and the absence of sanctions-related restrictions, where applicable.

The bid must comply with the procurement documents and the technical specification. The bidder must submit the RHAD Annex I technical description/bid form, the manufacturer’s technical documentation, documents confirming CE marking and compliance with MDR 2017/745, and five sterile samples in original packaging before the bid opening deadline. The sample packaging must show the tender name, reference number and bidder name. The bid must be submitted in the required structure, and conditional bids are not allowed. If the bidder relies on equivalence, it must explain it and attach supporting evidence. No additional precise qualification or suitability criteria were included in the ESPD; they must be checked in the tender documents.