Delivery of medical devices and tests divided into 23 parts. Lot No. 22: Foley catheters, urine collection bags, urine bag hangers

Delivery of medical devices and tests divided into 23 parts. Lot No. 22: Foley catheters, urine collection bags, urine bag hangers
1. A detailed description of the subject of the order is included in this ToR and: 1) Annex No. 1 - offer form; 2) Annex No. 2 - assortment and price form, which is also a description of the subject of the order; 3) Annex No. 4 - draft contract. 2. All requirements specified in the SWZ and the documents indicated above are minimum requirements and their fulfillment is obligatory. Failure to meet the above-mentioned minimum requirements will result in rejection of the offer as inconsistent with the terms of the contract pursuant to Art. 226 section 1 point 5 of the Public Procurement Law. 3. The Ordering Party requests that the contractor submit, together with the offer, the following evidence to confirm that the supplies offered meet the requirements specified by the Ordering Party in the ToR (in particular in the description of the subject of the order): For medical devices: 1) a current document confirming admission to trading and use as a medical device meeting the requirements within the meaning of the Act of April 7, 2022 on medical devices (consolidated text: Journal of Laws of 2024 item 1620) and compliance with the Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / (EU) 2017/746 on in vitro medical devices, having the product marked with the CE mark - i.e.: declaration of conformity and/or certificate of conformity issued by the manufacturer or authorized representative confirming that the product complies with the requirements essential; 2) certificate of a notified body (identifying the manufacturer and type of product), if the assessment was carried out with the participation of a notified body (if an assessment of a notified body was required). For biocidal products: 3) permission of the Minister of Health or the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to trade a biocidal product in accordance with the provisions of the Act of October 9, 2015 on biocidal products; For all parts of the order: 4) information materials (prospectus, catalogue, card, data form, part of the user manual/manufacturers description, statements and information or other materials specifying the subject of the order and its parameters, etc.), confirming the requirements contained in Annex No. 2. 5) declaration of the Contractor confirming that the offered subject of the order meets all the requirements specified by the Ordering Party, and that it is approved for marketing and use as a medical device in the territory of the Republic of Poland in accordance with the provisions of law - according to the template constituting Annex No. 8 to the SWZ. 2. The Ordering Party provides for the possibility of supplementing the evidence if the Contractor fails to submit the evidence or the evidence submitted is incomplete. The Contractor may supplement the evidence in question, but only at the request of the Ordering Party.