Poland – Medical consumables – Dostawa wyrobów medycznych jednorazowych na potrzeby Szpitala Miejskiego w Siemianowicach Śląskich Sp. z o .o. – część 2

The subject of the contract is the supply of single-use medical products for the needs of Szpital Miejski w Siemianowicach Śląskich Sp. z o.o. The subject of the contract is divided into 51 parts/sets. The detailed description of the subject of the contract is contained in Annex No. 2 to the SWZ. The offered subject of the contract must be factory new, approved for sale, free from physical and legal defects, and meet the requirements specified by the Contracting Authority. The Contracting Authority, in describing the subject of the contract, has detailed the assortment described in Annex No. 2, in accordance with its needs, and also allows for the submission of equivalent offers with parameters no worse than those specified by the Contracting Authority, if it follows from the description of the subject of the contract that the subject of the contract has been specified by indicating a trademark, patent, or origin. By equivalent solutions, the Contracting Authority means those that at least meet the requirements specified in the specification of the contract conditions and are characterized by technical, quality, and usability parameters no worse than those specified in the description of the subject of the contract. The Contractor who offers equivalent solutions described by the Contracting Authority is obliged to attach to the offer a list of all equivalent solutions offered and to prove their equivalence in relation to the solutions described in the tender documentation, indicating the name and position of the description of the subject of the contract to which they relate. The description of the proposed equivalent solutions should be attached to the offer and must be detailed enough so that the Contracting Authority, when evaluating the offer, can assess the fulfillment of the requirements regarding their technical parameters and decide whether the proposed solutions are equivalent. This means that the Contractor has the obligation to prove that the subject of the contract offered by him is equivalent to the one described by the Contracting Authority in the OPZ by indicating trademarks, patents, or origin, source, or a special process that characterizes the products supplied by a specific contractor. All trade names used in the SWZ serve only to specify the technical parameters, dimensions, or compatibility of the subject of the contract and are not an indication of the manufacturer. All names used in the description of the subject of the contract, the Contracting Authority treats as detailed information, which was used exclusively for the purpose of specifying the needs of the Contracting Authority. In the event that the description of the subject of the contract contains references to standards, technical assessments, technical specifications, and technical reference systems, as mentioned in Article 101(1)(2) and (3) of the Pzp Act, the Contracting Authority allows equivalent solutions in terms of methodology, scope, functionality, application possibilities, storage, operation, and other features described in the standards. Taking the above into account, the Contracting Authority indicates that in all places in the description of the subject of the contract, where the description was made by indicating specific standards, equivalent solutions described are allowed, and at the same time in each place the Contracting Authority introduces the definition "or equivalent" (legal basis: Article 42(3) of Directive 2014/24/EU). The offered product must meet all the principles and manner of approval for the sale of medical products, taking into account in particular the requirements regarding the quality, effectiveness, and safety of their use in accordance with: 1) Act on medical devices, i.e. of 07.04.2022 (i.e. Journal of Laws of 2024, item 1620); 2) Regulation of the Minister of Health of 5 November 2010 on the classification of medical devices (Journal of Laws of 2010, No. 215, item 1416); 3) Regulation of the Minister of Health on the essential requirements and conformity assessment procedures for medical devices of 17 February 2016 (Journal of Laws of 2016, item 211). 4) In the case of medical devices introduced into circulation for the first time after 26 May 2021, the Contractor is obligated to ensure that the medical devices have markings and information in accordance with the MDR (EU) 2017/745 (medical devices) and IVDR (EU) 2017/746 (in vitro diagnostics). The detailed conditions for the performance and acceptance of the subject of the contract are contained in the projected provisions of the contract, constituting Annex No. 4 to the SWZ. Deliveries will be made by transport at the Contractor's expense according to the rules established in the contract and the assortment-price form. The Contracting Authority reserves the right to request from the Contractor the provision of a certificate of proper transport conditions of the offered products in accordance with the manufacturer's requirements. The Contractor is obligated to present the appropriate documents confirming the proper storage of medical devices during transport within 48 hours from the request by the Contracting Authority. In the event of performance of the contract in part concerning transport using a subcontractor, the Contractor is responsible for the actions, omissions, and negligence of the subcontractor as for his own actions, omissions, and negligence, including compliance by the subcontractor in accordance with the rules established in the contract. The performance of orders must be carried out in full, original packaging. The Contractor will be obligated to deliver the goods according to the order (in terms of quantity and quality), in packaging guaranteeing safe transport and storage. Each contractor may submit one offer. The offer must be complete; otherwise, it will be rejected. The shelf life of the delivered medical devices is a minimum of 12 months from the date of delivery. Main place of performance: Szpital Miejski w Siemianowicach Śląskich Sp. z o. o. ul. 1-go Maja 9, 41 – 100 Siemianowice Śląskie.