Poland – Operating theatre devices and instruments – Dostawa staplerów chirurgicznych oraz ładunków do staplerów dla potrzeb CPiT w Bystrej.

The subject of the contract is the supply of surgical staplers and stapler loads for the needs of CPiT in Bystra. A detailed description of the subject of the contract in terms of assortment and quantities has been specified in the assortment-price form - Annex No. 2 to SWZ. The contract consists of 3 Lots. The Contracting Authority allows for the submission of partial offers for individual Lots. Each contractor has the option to submit an offer for any number of Lots chosen by them, with the proviso that the offer must include the valuation of the entire assortment within the Lots for which the Contractor submits an offer. A validity date of the offered assortment of at least 6 months from the moment of delivery of the order to the Contracting Authority is required. The Contracting Authority requires that all offered products be placed on the market and used in the territory of Poland, classified according to the applicable regulations: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, Act of 7 April 2022 on medical devices in the scope to which it relates. The offered medical devices (applies to all Lots and their positions) have EU declarations of conformity for the offered products issued by the manufacturer, signed by the authorised representative of the manufacturer and in the case of product classes higher than Class I, certificates of conformity issued by a notified body authorised 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 statement 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 product conformity assessment agreement with a notified body in the scope to which it relates. The offered medical devices (applies to all Lots and their positions) are marked with the CE marking, have instructions for use and are 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 have the name of the authorised representative and the address of their registered place of business. The requirements regarding the subject of the contract have been indicated in Section II of SWZ, Article 1 Subject of the Contract, in Annex No. 2 to SWZ - assortment-price form and in Annex No. 7 to SWZ - contract draft. The Contractor will be bound by the offer until 23.02.2027 (90 days). Contract implementation period 12 months (contract implementation will begin no earlier than 13.01.2026).