Poland – Medical consumables – Supply of disposable implantable medical devices and endoprostheses for the needs of Szpital Miejski w Siemianowicach Śląskich Sp. z o. o.

Opportunity description

1. The subject of the contract is the supply of disposable implantable medical devices and endoprostheses for the needs of Szpital Miejski w Siemianowicach Śląskich Sp. z o. o. 2. The subject of the contract has been divided into 39 parts/packages. 4. A detailed description of the subject of the contract is contained in Annexes: No. 2, 9 and, if applicable, 9A to the SWZ. The offered subject of the contract must be brand-new, authorized for placing on the market, free from physical and legal defects, and meet the requirements specified by the Contracting Authority. 5. In describing the subject of the contract, the Contracting Authority specified in detail the assortment described in Annex No. 2, in accordance with its needs, and also permits the submission of equivalent tenders with parameters no worse than those specified by the Contracting Authority if the description of the subject of the contract could indicate that the subject of the contract was specified by reference to a trademark, patent, or origin. By equivalent solutions, the Contracting Authority means solutions that at least meet the requirements specified in the procurement specifications and have technical, quality, and functional parameters no worse than those specified in the description of the subject of the contract. A Contractor offering solutions equivalent to those described by the Contracting Authority is required to attach to the tender a list of all equivalent solutions offered and demonstrate their equivalence to the solutions described in the tender documentation, indicating the name and item in the description of the subject of the contract to which this applies. The description of the proposed equivalent solutions should be attached to the tender and must be sufficiently detailed to enable the Contracting Authority, when evaluating the tender, to assess compliance with the requirements concerning their technical parameters and determine whether the proposed solutions are equivalent. This means that the Contractor is obliged to demonstrate that the subject of the contract offered by it is equivalent to that described by the Contracting Authority in the OPZ through reference to trademarks, patents or origin, source, or a particular process that characterizes the products supplied by a specific contractor; All proper names used in the SWZ serve only to specify the technical parameters, dimensions, or compatibility of the subject of the contract and do not constitute an indication of the manufacturer. The Contracting Authority treats all names used in the description of the subject of the contract as clarifying information used exclusively to define the Contracting Authority’s needs more precisely. If the description of the subject of the contract contains references to standards, technical assessments, technical specifications, and technical reference systems referred to in Article 101(1)(2) and (3) of the Pzp Act, the Contracting Authority permits equivalent solutions in terms of the methodology of procedure, scope, functionality, applicability, storage, operation, and other characteristics 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 reference to specific standards, solutions equivalent to those described are permitted, and at the same time, in each such place, the Contracting Authority introduces the phrase "or equivalent" (legal basis: Article 42(3) of Directive 2014/24/EU). 6. The offered product must comply with all rules and procedures for placing medical devices on the market, taking into account in particular the requirements concerning their quality, effectiveness, and safety of use, in accordance with: 1) the Act on Medical Devices of 07.04.2022 (consolidated text, Journal of Laws of 2024, item 1620); 2) the 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) the Regulation of the Minister of Health on essential requirements and conformity procedures for medical devices of 17 February 2016 (Journal of Laws of 2016, item 211). 4) In the case of medical devices placed on the market for the first time after 26 May 2021, the Contractor is obliged to ensure that the medical devices bear markings and information in accordance with the MDR Regulation (EU) 2017/745 (medical devices) and IVDR (EU) 2017/746 (in vitro diagnostics). 7. Detailed conditions for the performance and acceptance of the subject of the contract are contained in the draft contractual provisions constituting Annexes No. 4 and 9 and Annexes No. 4A and 9A, if applicable, to the SWZ. 8. Deliveries will be made by transport at the Contractor’s expense in accordance with the rules established in the contract, deposit agreement, Annexes No. 9 and 9A, assortment and price form, and detailed description of the subject of the contract. 9. The Contracting Authority reserves the right to request that the Contractor provide certification of the proper transport conditions for the offered products in accordance with the manufacturer’s requirements. Within 48 hours of being requested by the Contracting Authority, the Contractor is obliged to present appropriate documents confirming the proper storage of medical devices during transport. 10. If the part of the contract concerning transport is performed using a subcontractor, the Contractor shall be liable for the subcontractor’s acts, omissions, and negligence as for its own acts, omissions, and negligence, including for the subcontractor’s compliance with the rules established in the contract. 11. The Contractor will be obliged to deliver the goods in accordance with the order (in terms of quantity and quality), in packaging ensuring safe transport and storage. 12. Each contractor may submit one tender. 13. The shelf life of the delivered medical devices shall be at least 12 months from the date of delivery. 14. Main place of performance: Szpital Miejski w Siemianowicach Śląskich Sp. z o. o., ul. 1-go Maja 9, 41–100 Siemianowice Śląskie. Revision knee joint endoprosthesis Cementless hip joint endoprosthesis with a cup manufactured using 3D technology Meniscus suturing set Polyethylene hip joint cups Set for stabilization of periprosthetic femoral fractures Schanz-type pins for external bone fixators Knee joint meniscus suturing set Set for fixation of long-bone shafts External fixator for long bones Set for fixation of fractures of the distal fibular epiphysis. Set for revision reconstruction of the hip joint Set for reconstruction of the anterior and posterior cruciate ligaments. Set for fixation of the distal 1/2 of the tibia Cannulated bone screws Total hip joint endoprosthesis Total cementless HA-coated hip joint endoprosthesis expandable to a bipolar option Total cemented knee joint endoprosthesis Vacuum cement mixing set Osteosynthesis materials Hip and condylar screw-plate (sterile) Cement with gentamicin and clindamycin Set for osteotomy of the first metatarsal Set for fixation of fractures of the humeral epiphyses Set for fixation of fractures of the distal radial epiphysis. Set for fixation of the proximal tibial epiphysis Set for fixation of the proximal ulnar epiphysis Total cementless metaphyseal hip joint endoprosthesis Locked intramedullary nails Set for fixation of the distal femoral epiphysis Set for peri-knee osteotomies. GAMMA-type nail or equivalent TITANIUM Cannulated titanium bone screws Membrane for reconstruction of cartilage and osteochondral defects Set for clavicle fixation Inside-out meniscus suturing set Knotless implant and PEEK implant for tissue fixation in bone Cone reducer system for revision hip joint surgery Set for fixation of hand bones Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.