Reagents and accessories for urine analyser 2

The exclusion grounds mainly concern participation in a criminal organisation, corruption and fraud. The bidder must confirm whether it or any member of its administrative, management or supervisory body, a procurator or another person authorised to represent it has been finally convicted of these offences within the last five years, or whether the disqualification period set out in the conviction is still in force. If an exclusion ground applies, the bidder may submit evidence of self-cleaning measures to restore reliability. The tender documents also include references to whether the information is electronically available. The machine-readable notice did not include any more precise exclusion grounds; these must be checked in the procurement documents.

The machine-readable notice did not include precise qualification, suitability or compliance requirements beyond the tender documents; these must be checked in the procurement documents. The tender documents also require the bidder to be the official representative and/or official distributor of the offered product and to submit a document or copy proving the manufacturer’s authorisation to sell and provide technical support. The bidder must also submit the completed participation application, the completed price form, the completed technical description form, and manufacturer-issued technical data documents such as certificates, safety data sheets, user manuals, and storage and preservation conditions. For the offered reagents and accessories, CE marking is required and they must comply with Regulation (EU) 2017/746, or be on the market under the transitional provisions of that Regulation; if the bidder offers products that currently comply with Directive 98/79/EC, the manufacturer’s confirmation of replacement by an IVDR-compliant product by the end of the transition period must be submitted.