Poland – Disposable non-chemical medical consumables and haematological consumables – Dostawa wyrobów medycznych jednorazowego użytku dla potrzeb Centrum Pulmonologii i Torakochirurgii w Bystrej (powtórka w zakresie unieważnionych Pakietów)

The subject of the contract is the supply of single-use medical products for the needs of the Pulmonology and Thoracic Surgery Centre in Bystra (repetition in the scope of annulled packages). The detailed description of the subject of the contract in terms of assortment and quantities is specified in the assortment-price form - Annex No. 2 to the SWZ. The contract consists of 26 Packages. Partial offers for individual Packages (one or several) are allowed, within individual Packages, an offer for the full scope of the subject of the contract relating to a given Package is required. A validity date of the offered assortment of at least 6 months from the date of delivery of the contract to the Purchaser is required, unless a different validity date is indicated in Annex No. 2 to the SWZ. The Purchaser requires that the entire assortment be new and unused. All offered medical materials, being medical devices, must be placed on the market and used in the territory of Poland, classified according to the applicable regulations: Regulation (EU) 2017/745 on medical devices, Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Act of 7.04.2022 on medical devices (i.e. Journal of Laws 2024, item 1620) in the scope to which it applies. The offered medical devices must have the manufacturer's EU Declaration of Conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorized to certify under the MDR/MDD regulations. In the case of using the extended transitional period (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or directive 93/42/EEC) in connection with the need to confirm that the offered medical device can be placed on the market under the transitional provisions, a declaration of use of the transitional period, the manufacturer's own declaration specifying the end date of the transitional period, the manufacturer's quality management system certificate, confirmation of the conclusion of a contract for the assessment of conformity of the product with a notified body. The offered products must be marked with the CE marking, have instructions for use in Polish and be marked with the name/brand name or trademark, address of the registered place of business of the manufacturer. If the registered place of production is outside the EU, they must have the name of the authorized representative and the address of their registered place of business. The requirements for the subject of the contract are indicated in Section II of the SWZ, Item 1 Subject of the Contract, in Annex No. 2 to the SWZ - assortment-price form and in Annex No. 7 to the SWZ - contract draft. The Contractor will be bound by the offer until 08.12.2026 (90 days), Contract execution period 10 months.