Poland – Medical consumables – Dostawa wyrobów medycznych wszczepialnych jednorazowych, endoprotez na potrzeby Szpitala Miejskiego w Siemianowicach Śląskich Sp. z o .o.

The subject of the contract is the supply of single-use implantable medical devices, endoprostheses for the needs of the Municipal Hospital in Siemianowice Śląskie Sp. z o. o. 2. The subject of the contract is divided into 39 parts/packages. 4. The detailed description of the subject of the contract is contained in the Annexes: No. 2, 9 and if applicable 9A to 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. 5. The Contracting Authority, describing the subject of the contract, has detailed the assortment described in Annex No. 2, according to its needs, also allows the possibility of submitting equivalent offers with parameters not worse than those specified by the Contracting Authority, if from the description of the subject of the contract it could be concluded that the subject of the contract was specified by indicating a trademark, patent or origin. By equivalent solutions, the Contracting Authority understands such solutions which at least meet the requirements specified in the specification of the contract conditions and are characterized by technical, quality and usability parameters not 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 it relates. The description of the proposed equivalent solutions should be attached to the offer and must be detailed enough for the Contracting Authority, when evaluating the offer, to assess the fulfillment of the requirements regarding their technical parameters and to 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 in relation 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 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 art. 101 para. 1 point 2) and para. 3 of the Pzp Act, the Contracting Authority allows equivalent solutions in terms of methodology, scope, functionality, application, storage, operation and other features described in the standards. Taking into account the above, the Contracting Authority indicates that in all places in the description of the subject of the contract, where the description was made by reference to specific standards, equivalent solutions described are allowed, and at the same time in each place the Contracting Authority introduces the term "or equivalent" (legal basis art. 42 para. 3 of Directive 2014/24/EU). 6. The offered product must meet all the rules and procedures for the admission to sale of medical devices, 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 basic 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 obliged to ensure that medical devices have markings and information in accordance with the MDR (EU) 2017/745 (medical devices) and IVDR (EU) 2017/746 (in vitro diagnostics). 7. The detailed conditions for the implementation and acceptance of the subject of the contract are contained in the planned provisions of the contract, constituting Annex No. 4 and 9 and Annexes No. 4A and 9A if applicable to SWZ 8. Deliveries will be made by transport at the Contractor's expense according to the rules established in the contract, deposit agreement, Annexes No. 9 and 9A, assortment-price form and detailed description of the subject of the contract. 9. The Contracting Authority reserves the right to request the Contractor to provide proof of proper transport conditions for the offered products in accordance with the manufacturer's requirements. The Contractor is obliged to present the relevant documents confirming the proper storage of medical devices during transport within 48 hours from the request by the Contracting Authority. 10. In the event of the execution of the contract in part relating to 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 according to the rules established in the contract. 11. The Contractor will be obliged to deliver the goods according to the contract (in terms of quantity and quality), in packages guaranteeing safe transport and storage. 12. Each contractor may submit one offer. 13. The shelf life of the supplied medical devices is a minimum of 12 months from the date of delivery. 14. Main place of performance: Municipal Hospital in Siemianowice Śląskie Sp. z o. o. ul. 1-go Maja 9, 41 – 100 Siemianowice Śląskie.