Intraocular lenses 2

The bidder must confirm that neither it nor the members of its management, governing or supervisory bodies have been convicted within the last 5 years for participation in a criminal organisation, corruption, fraud, or any other serious offence listed in the tender documents. If any exclusion ground applies, the bidder may submit evidence of self-cleaning measures where permitted. The machine-readable notice did not show all exclusion grounds in full; the remaining grounds must be checked in the tender documents.

The bidder must have properly performed at least one contract within the last 36 months for the supply of intraocular lenses or other comparable ophthalmic implants to healthcare providers. The reference contract must be worth at least EUR 630,000 excluding VAT, and the bidder must provide the contract value, dates and the other contracting parties. The contracting authority may request documents proving the reference and proper performance of the contract. For compliance, the bidder must submit the manufacturer’s technical data sheet, declaration of conformity, instructions for use, package labelling and, where applicable, an EC certificate. The offered intraocular lens must have been in clinical use for at least 5 years before the tender submission deadline. At least one prospective randomized clinical study with at least 100 patients and a minimum follow-up of 6 months must have been published for the lens model in a peer-reviewed international scientific journal, and the bidder must provide the bibliographic reference and DOI number. In addition, the bidder must submit the participation application, pricing form, technical description form, and confirm compliance, equivalence and the absence of international sanctions. If any precise form or evidence requirement is not fully set out here, it must be checked in the tender documents.