Poland – Laboratory reagents – Dostawa odczynników do oznaczeń biochemicznych z najmem analizatora na okres 48 miesięcy

The subject of the order is: the supply of reagents for immunochemical determinations with the rental of an analyser for a period of 48 months. 2. The detailed description of the subject of the order includes a price list and technical specification of the analyser, which are Annexes 1A and 4 to the SWZ. 1.1. The ordering party, in order to confirm the conformity of the offered supplies, requires the submission of the following subject-related evidentiary means with the offer: 1) 1) A declaration that the offered assortment has been approved and placed on the market in accordance with the provisions of the Act of 7 April 2022 on medical devices (Journal of Laws of 2022, item 974) and has current declarations of conformity and certificates from the notified body and will be made available upon each request of the ordering party after signing the contract - the content of the declaration is entered in the offer form, which is Annex 1 to the SWZ 2) Catalogue card of the analyser confirming the parameters indicated in Annex 4 to the SWZ 3) Leaflets for the offered reagents 4) Declaration of conformity of the analyser – a document issued by the manufacturer of the product or its authorised representative. 5) Catalogue cards of the manufacturer and/or user instructions for the analyser confirming the evaluated parameters (criteria for evaluating offers: K2, K3, K4, K5 described in point XV of the SWZ) 2. This concerns point VIII.1 item 1). The ordering party does not envisage the supplementation of the subject-related evidentiary means indicated in point VIII.1 item 1). Offers that do not contain the above documents will be rejected on the basis of Article 226(5) of the PZP Act. 3. This concerns point VIII.1 items 2), 3), 4). In the event that the Contractor does not submit the documents indicated in point VIII.1 items 2), 3), 4) with the offer or the submitted subject-related evidentiary means are incomplete, the ordering party will call for their submission or supplementation within a specified deadline. 4. This concerns point VIII.1 item 5). The ordering party does not envisage the supplementation of the documents indicated in point VIII.1 item 5) confirming the evaluated parameters. In the event of a lack of documents, the Contractor will receive 0 points. 5. Subject-related evidentiary means drawn up in a foreign language shall be submitted together with a translation into Polish. 6. The ordering party requires that the subject-related evidentiary means be drawn up in electronic form and endorsed with a qualified signature by the Contractor. 7. In the event that the subject-related evidentiary means have been drawn up in electronic form and endorsed with a qualified signature by their issuer (authorised entity), they shall be submitted in such form. 8. In the case where the subject-related evidentiary means have been issued in paper form, a digital representation of the document endorsed with a qualified signature by the contractor shall be submitted. 9. The ordering party requires that the subject-related evidentiary means confirm the factual status as of the date of submission of the offers. 10. The ordering party requires that the subject-related evidentiary means be up-to-date as of the date of submission/completion. 7. The ordering party requires that the subject-related evidentiary means be up-to-date as of the date of submission/completion.