Poland – Reagents and contrast media – Wyroby medyczne do diagnostyki in vitro z dostawą do bezpośrednich odbiorców. Części 1÷2

1. OBJECT OF THE CONTRACT: 1.1. The subject of the contract is the purchase of in vitro diagnostic medical devices (diagnostic tests) in the quantities specified in the Detailed Description of the Subject of the Contract (hereinafter referred to as DDS or DS), necessary for monitoring ARV therapy for patients infected with the HIV virus and AIDS patients, including delivery to laboratories performing tests for specialist centres/medical facilities selected through a tender for Implementers, within the implementation of the Government Health Policy Program entitled: "Antiretroviral treatment of people living with HIV in Poland for the years 2022-2026" (hereinafter referred to as: Health Policy Program) https://www.gov.pl/web/zdrowie/rzadowy-program-polityki-zdrowotnej-leczenie-antyretrowirusowe-osob-zyjacych-z-wirusem-hiv-w-polsce-na-lata-2022-2026) 1.2. Each of the parts listed in the DS is the subject of a separate procedure. 1.3. The contract must be fully implemented in accordance with the requirements specified in the SWZ, DS and the rules described in the Draft Contract Clauses (hereinafter referred to as PPC), which are annexes to the SWZ. 1.4. The DS containing the requirements and conditions for the implementation of each part of the contract is an annex to the SWZ. 1.5. The Contracting Authority allows equivalent solutions in accordance with Article 99(5) and (6) of the Act of 11 September 2019 – Public Procurement Law (Journal of Laws of 2024, item 1320, as amended), provided that the offered sets of reagents and all components necessary to perform the test/marking covered by the given part of the contract, in accordance with the relevant DS, are introduced into circulation and use in the territory of the Republic of Poland, and the components constituting in vitro diagnostic medical devices or their accessories have a valid CE marking and: 1.5.1. meet the requirements of Regulation (EU) 2017/746 of the European Parliament and of the Council (IVDR) – in the class and according to the classification rule applicable to the intended use of the product declared by the manufacturer, OR the transitional provisions of Article 110 IVDR – if they apply to a legacy product, provided that all the conditions applicable to the class and status of the product are met, particularly with regard to the quality management system, timely submission of an application to a notified body, conclusion of an agreement with it, absence of a significant change in the design and intended use of the product and compliance with the statutory deadlines for further introduction into circulation OR meet the requirements of the Act of 7 April 2022 on medical devices (Journal of Laws of 2024, item 1620) 1.5.2. meet the clinical purpose, technology of execution, scope of the test and all functional, operational, analytical and diagnostic requirements specified in the DS for the given part of the procedure, ensuring parameters not worse than required, in particular appropriately to the type of package: type and scope of the marked parameter, type and minimum amount of material, analytical or diagnostic sensitivity and specificity, precision, repeatability and reproducibility, measurement range, linearity, detection limit, identification or differentiation capability, quality of reading, coverage depth, quality of population separation, range of detectable variants/subtypes/alleles/populations or other parameters applicable to the given method – in accordance with the DS; 1.5.3. are fully compatible with the equipment, technical configuration, software, operating materials, control or calibration materials and data formats and reporting required in the DS for the given Part and all recipients indicated therein; compatibility also includes the correct software versions, optical or modular configuration and sample preparation, reaction and analysis technology – if applicable; 1.5.4. enable the performance of the test from the material indicated in the DS while maintaining the requirements related to sample preparation, material stability, transport, storage, execution time and safety of use, in accordance with the DS and the manufacturer's documentation; 1.5.5. meet the logistical requirements specified in the DS, including those related to the validity period at delivery to the place indicated in the SWZ/DS, transport and storage conditions and maintenance of the proper temperature chain, confirmed by the appropriate documentation – if applicable; 1.5.6. meet – according to the status of the product – the registration and identification obligations resulting from the IVDR, the Act on medical devices and the executive acts of the European Union in force on the date of submission of offers and implementation of the contract, particularly in the scope of SRN, UDI, Basic UDI-DI / EUDAMED-DI and EUDAMED, if applicable; 1.5.7. do not require additional, unplanned in the DS equipment, IT, licensing, service or validation upgrading on the part of the Contracting Authority or recipients; 1.5.8. have the information and instructions required by the regulations for a professional user, with the instruction for use in Polish being available no later than at delivery, in accordance with the regulations applicable to medical devices. 1.6. In accordance with Article 101(5) and (6) of the pzp Act, the burden of proof of equivalence lies with the Contractor. Lack of unambiguous confirmation means that equivalence has not been demonstrated.