Compliance requirements
The bidder and its management or control body members must not have been finally convicted within the last five years for participation in a criminal organisation, corruption, fraud or other serious offences listed in the tender documents. If such a ground exists, the bidder may submit evidence of self-cleaning measures where permitted. The contracting authority may also request evidence that no exclusion ground applies.
Qualification criteria and exclusion grounds
The bidder must have successfully performed at least one contract in the 36 months before the start of the procurement whose subject was 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. The contracting authority may request evidence of the reference and of proper performance of the contract. The bid must also include the required technical data sheet for the offered medical device/product, manufacturer declarations of conformity, instructions for use, packaging 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 randomised clinical study with at least 100 patients and a follow-up period of at least 6 months must have been published for the offered lens model in a peer-reviewed international scientific journal, and the bidder must provide the bibliographic reference and DOI number.