Part No. 4: Hygienic underpad

1. The detailed description of the subject of the order is contained in this SWZ and: 1) Annex No. 1 – offer form; 2) Annex No. 2 – assortment and price form, which also constitutes the 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 constitute minimum requirements, and their fulfillment is obligatory. Failure to meet the aforementioned minimum requirements will result in the rejection of the offer as non-compliant with the order conditions pursuant to Art. 226 sec. 1 point 5 of the Public Procurement Law. 3. The Contracting Authority requires the contractor to submit the following, subject-specific evidence with the offer to confirm that the offered supplies meet the requirements specified by the Contracting Authority in the SWZ (in particular in the description of the subject of the order): For medical devices: 1) a current document confirming market access and usability as a medical device meeting the requirements within the meaning of the Act of April 7, 2022, on Medical Devices (Journal of Laws 2024, item 1620) and compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR) / (EU) 2017/746 on in vitro diagnostic medical devices, bearing the CE mark - i.e.: declaration of conformity and/or certificate of conformity issued by the manufacturer or authorized representative confirming that the device complies with the essential requirements; 2) a certificate from a notified body (identifying the manufacturer and type of device), if the assessment was carried out with the participation of a notified body (if an assessment by a notified body was required). For biocidal products: 3) permission from the Minister of Health or the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for the circulation of 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 (brochure, catalog, data sheet, data form, part of the user manual/manufacturer's 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) a statement from the Contractor, confirming that the offered subject of the order meets all requirements specified by the Contracting Authority, and that it is permitted for circulation and use as a medical device in the Republic of Poland in accordance with the law - according to the template constituting Annex No. 8 to the SWZ. 2. The Contracting Authority provides for the possibility of supplementing the subject-specific evidence if the Contractor does not submit the subject-specific evidence or the submitted subject-specific evidence is incomplete. The Contractor may supplement the subject-specific evidence, but only upon the Contracting Authority's request.