Poland – Reagents and contrast media – In vitro diagnostic medical devices with delivery to direct recipients. Parts 1÷2

Opportunity description

1. DEFINITION OF THE SUBJECT MATTER OF THE CONTRACT: 1.1. The subject matter 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 matter of the contract (hereinafter SzOPZ or OPZ), necessary for monitoring ARV therapy of patients infected with HIV and suffering from AIDS, together with shipment to laboratories performing tests for specialist centers/medical facilities selected through a competition as Implementers, as part of the implementation of the Government Health Policy Program entitled: “Antiretroviral treatment of people living with HIV in Poland for the years 2022-2026” (hereinafter: 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 OPZ constitutes the subject matter of a separate procedure. 1.3. The contract must be performed in full in accordance with the requirements set out in the SWZ and OPZ and under the terms described in the Draft contractual provisions (hereinafter PPU), which constitute annexes to the SWZ. 1.4. The OPZ containing the requirements and conditions for the performance of each part of the contract constitutes an annex to the SWZ. 1.5. The Contracting Authority permits equivalent solutions within the meaning of Art. 99(5–6) of the Act of 11 September 2019 – Public Procurement Law (Journal of Laws of 2024, item 1320, as amended), provided that the offered reagent kits and all components necessary to perform the test/assay covered by the relevant part of the contract, in accordance with the applicable OPZ, have been placed on the market and put into use in the territory of the Republic of Poland, and components constituting in vitro diagnostic medical devices or their accessories bear 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 appropriate to the device’s intended purpose declared by the manufacturer, OR the transitional provisions of Art. 110 IVDR – if they apply to a legacy device, subject to fulfillment of all conditions applicable to the class and status of the device, in particular those concerning the quality management system, timely submission of an application to a notified body, conclusion of an agreement with it, the absence of a significant change in the design and intended purpose of the device, and compliance with statutory deadlines for its continued placing on the market OR meet the requirements of the Act of 7 April 2022 on medical devices (Journal of Laws of 2024, item 1620) 1.5.2. correspond to the clinical purpose, performance technology, scope of the test and all functional, operational, analytical and diagnostic requirements specified in the OPZ for the relevant part of the procedure, ensuring parameters no worse than those required, in particular, as appropriate to the type of package: the type and scope of the parameter being assayed, the type and minimum quantity of material, analytical or diagnostic sensitivity and specificity, precision, repeatability and reproducibility, measurement range, linearity, limit of detection, identification or differentiation capability, read quality, depth of coverage, quality of population separation, range of detected variants/subtypes/alleles/populations or other parameters appropriate to the given method – in accordance with the OPZ; 1.5.3. are fully compatible with the equipment, technical configuration, software, consumables, control or calibration materials, and data and reporting formats required in the OPZ for the relevant Part and all recipients specified therein; compatibility also includes the appropriate software versions, optical or modular configuration, and sample preparation, reaction and analysis technology – where applicable; 1.5.4. enable the test to be performed using the material specified in the OPZ while meeting the requirements concerning sample preparation, material stability, transport, storage, performance time and safety of use, in accordance with the OPZ and the manufacturer’s documentation; 1.5.5. meet the logistical requirements specified in the OPZ, including those concerning the shelf life upon delivery to the location specified in the SWZ/OPZ, transport and storage conditions, and maintenance of the appropriate temperature chain, confirmed by relevant documentation – where applicable; 1.5.6. fulfill – as appropriate to the status of the device – the registration and identification obligations arising from the IVDR, the Act on medical devices and European Union implementing acts in force on the date of submission of tenders and performance of the contract, in particular with regard to SRN, UDI, Basic UDI-DI / EUDAMED-DI and EUDAMED, insofar as applicable; 1.5.7. do not require additional hardware, IT, licensing, servicing or validation equipment not provided for in the OPZ on the part of the Contracting Authority or recipients; 1.5.8. possess the information and instructions required by law for professional users, with the instructions for use in Polish to be available no later than upon delivery, in accordance with the regulations applicable to medical devices. 1.6. Pursuant to Art. 101(5) and (6) of the Public Procurement Law, the burden of demonstrating equivalence rests with the Contractor. The absence of unambiguous confirmation means that equivalence has not been demonstrated. 1. DESCRIPTION 1.1. The subject matter of the contract is the delivery, at the contractor’s expense and risk, of reagent kits for detecting HLA-B*5701 using real-time PCR (Real Time PCR), in accordance with the OPZ. 1.2. The number of reagent kits must allow 300 effective results to be obtained. 1.3. Shelf life – at least 12 months from the date of delivery. 2. SUBJECT-MATTER EVIDENCE: 2.1. Pursuant to Arts. 105 and 106 of the Public Procurement Law, in order to confirm that the offered supplies comply with the requirements, characteristics or criteria specified in the description of the subject matter of the contract, the tender evaluation criteria or the requirements related to contract performance, the Contracting Authority requires contractors to submit the following documents: 2.1.1. Instructions for use (IFU) for the IVD medical device and, for components that do not independently constitute an IVD medical device, a technical data sheet together with a product description or methodology description or other manufacturer’s documentation (if the IFU does not contain all data necessary to assess compliance with the OPZ). These documents must make it possible to verify at least: 1) the intended purpose of the device, 2) the scope of the test/assay 3) the type, quantity and collection conditions of the test material 4) the composition of the kit and the components necessary to perform the test 5) storage conditions, stability and shelf life 6) the basic stages of sample preparation and performance of the assay 7) the analytical, diagnostic and operational parameters required in the OPZ 8) compatibility with the equipment, technical configuration, software and consumables required in the OPZ 9) limitations of the method 2.1.2. The manufacturer’s declaration of full compatibility with each platform, item of equipment, technical configuration, software and consumable required in the OPZ 2.1.3. The EU declaration of conformity issued by the manufacturer for components constituting IVD medical devices, confirming compliance with Regulation (EU) 2017/746 (IVDR), and, in the case of a legacy device, documents confirming eligibility to use the transitional provisions of Art. 110 IVDR; if participation of a notified body is required for the device concerned or a certificate has been issued – also the notified body’s certificate or an equivalent document confirming conformity assessment with its participation. If the statutory deadline for concluding an agreement with a notified body has expired by the tender submission date, the Contractor shall also submit a document confirming its conclusion 2.1.4. A declaration by the manufacturer or authorized representative in the EU concerning the legal and registration status of the device in EUDAMED, including at least: the category/status of the device (new / legacy / being withdrawn – where applicable), the device class according to the IVDR, the SRN number or information on obtaining it, the Basic UDI-DI / EUDAMED-DI number – if assigned – or the declared registration date; and if such an obligation arises from the regulations in force on the date of tender submission or performance of the delivery – also a document confirming fulfillment of the obligations related to the lawful placing of the device on the market or putting it into use in the territory of the Republic of Poland 2.1.5. A document confirming that transport and storage conditions compliant with the manufacturer’s requirements are ensured for all offered components, covering at least the method of temperature monitoring and the ability to maintain the appropriate temperature chain to the delivery location specified in the SWZ/OPZ 2.1.6. Safety data sheets (SDS) – if there is an obligation to prepare them for the relevant component under REACH or CLP regulations 2.2. A Contractor relying on equivalent solutions is required to submit with the tender the subject-matter evidence listed in points 2.1.1. - 2.1.6. and additional subject-matter evidence in the form of: 2.2.1. validation data, a performance evaluation report or other reliable manufacturer’s documents confirming fulfillment of the parameters required in the OPZ for the relevant part, in particular the analytical, diagnostic, operational and compatibility parameters appropriate to the relevant method, together with certificates of analysis for the batch (CoA) or equivalent batch quality-control documents – where applicable 2.2.2. a comparison of the offered solution’s compliance with the requirements of the relevant OPZ for the relevant part, indicating for each requirement the source document and the place where it is confirmed 2.3. Pursuant to Art. 107(1) of the Public Procurement Law, the Contractor is required to submit the above-mentioned subject-matter evidence with the tender. The Contractor should exercise every diligence to ensure that these documents are complete and contain all information necessary to enable the Contracting Authority to verify their correctness and compliance with the requirements of the SWZ 2.4. Pursuant to Art. 107(2) of the Public Procurement Law, the Contracting Authority provides for the possibility of issuing a one-time request to supplement the subject-matter evidence referred to in points 2.1.1. - 2.1.6. and points 2.2.1.-2.2.2. within the time limit specified by the Contracting Authority. A request for supplementation does not apply where the subject-matter evidence serves to confirm compliance with the characteristics or criteria specified in the description of the tender evaluation criteria 2.5. Subject-matter evidence shall be submitted in electronic form in the manner provided for in the provisions of the Regulation of the President of the Council of Ministers of 30 December 2020 on the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in a public procurement or design contest procedure (Journal of Laws of 2020, item 2452), issued pursuant to Art. 70 of the Public Procurement Law 2.6. The Contracting Authority permits the documents referred to in points 2.1.1.-2.1.6. and points 2.2.1.-2.2.2. to be submitted in Polish or English without the need for translation 1. DESCRIPTION 1.1. The subject matter of the contract is the delivery, at the contractor’s expense and risk, of laboratory reagent kits intended for genotypic determination of HIV-1 resistance to antiretroviral drugs belonging to the following inhibitor classes: reverse transcriptase (NRTI and NNRTI), protease (PI) and integrase (INSTI), using the Sanger sequencing method, in accordance with the OPZ. 1.2. The number of reagent kits must allow 1 300 effective results to be obtained. 1.3. Shelf life – at least 5 months from the date of delivery to the final recipients. 2. SUBJECT-MATTER EVIDENCE: 2.1. Pursuant to Arts. 105 and 106 of the Public Procurement Law, in order to confirm that the offered supplies comply with the requirements, characteristics or criteria specified in the description of the subject matter of the contract, the tender evaluation criteria or the requirements related to contract performance, the Contracting Authority requires contractors to submit the following documents: 2.1.1. Instructions for use (IFU) for the IVD medical device and, for components that do not independently constitute an IVD medical device, a technical data sheet together with a product description or methodology description or other manufacturer’s documentation (if the IFU does not contain all data necessary to assess compliance with the OPZ). These documents must make it possible to verify at least: 1) the intended purpose of the device, 2) the scope of the test/assay 3) the type, quantity and collection conditions of the test material 4) the composition of the kit and the components necessary to perform the test 5) storage conditions, stability and shelf life 6) the basic stages of sample preparation and performance of the assay 7) the analytical, diagnostic and operational parameters required in the OPZ 8) compatibility with the equipment, technical configuration, software and consumables required in the OPZ 9) limitations of the method 2.1.2. The manufacturer’s declaration of full compatibility with each platform, item of equipment, technical configuration, software and consumable required in the OPZ 2.1.3. The EU declaration of conformity issued by the manufacturer for components constituting IVD medical devices, confirming compliance with Regulation (EU) 2017/746 (IVDR), and, in the case of a legacy device, documents confirming eligibility to use the transitional provisions of Art. 110 IVDR; if participation of a notified body is required for the device concerned or a certificate has been issued – also the notified body’s certificate or an equivalent document confirming conformity assessment with its participation. If the statutory deadline for concluding an agreement with a notified body has expired by the tender submission date, the Contractor shall also submit a document confirming its conclusion 2.1.4. A declaration by the manufacturer or authorized representative in the EU concerning the legal and registration status of the device in EUDAMED, including at least: the category/status of the device (new / legacy / being withdrawn – where applicable), the device class according to the IVDR, the SRN number or information on obtaining it, the Basic UDI-DI / EUDAMED-DI number – if assigned – or the declared registration date; and if such an obligation arises from the regulations in force on the date of tender submission or performance of the delivery – also a document confirming fulfillment of the obligations related to the lawful placing of the device on the market or putting it into use in the territory of the Republic of Poland 2.1.5. A document confirming that transport and storage conditions compliant with the manufacturer’s requirements are ensured for all offered components, covering at least the method of temperature monitoring and the ability to maintain the appropriate temperature chain to the delivery location specified in the SWZ/OPZ 2.1.6. Safety data sheets (SDS) – if there is an obligation to prepare them for the relevant component under REACH or CLP regulations 2.2. A Contractor relying on equivalent solutions is required to submit with the tender the subject-matter evidence listed in points 2.1.1. - 2.1.6. and additional subject-matter evidence in the form of: 2.2.1. validation data, a performance evaluation report or other reliable manufacturer’s documents confirming fulfillment of the parameters required in the OPZ for the relevant part, in particular the analytical, diagnostic, operational and compatibility parameters appropriate to the relevant method, together with certificates of analysis for the batch (CoA) or equivalent batch quality-control documents – where applicable 2.2.2. a comparison of the offered solution’s compliance with the requirements of the relevant OPZ for the relevant part, indicating for each requirement the source document and the place where it is confirmed 2.3. Pursuant to Art. 107(1) of the Public Procurement Law, the Contractor is required to submit the above-mentioned subject-matter evidence with the tender. The Contractor should exercise every diligence to ensure that these documents are complete and contain all information necessary to enable the Contracting Authority to verify their correctness and compliance with the requirements of the SWZ 2.4. Pursuant to Art. 107(2) of the Public Procurement Law, the Contracting Authority provides for the possibility of issuing a one-time request to supplement the subject-matter evidence referred to in points 2.1.1. - 2.1.6. and points 2.2.1.-2.2.2. within the time limit specified by the Contracting Authority. A request for supplementation does not apply where the subject-matter evidence serves to confirm compliance with the characteristics or criteria specified in the description of the tender evaluation criteria 2.5. Subject-matter evidence shall be submitted in electronic form in the manner provided for in the provisions of the Regulation of the President of the Council of Ministers of 30 December 2020 on the method of preparing and transmitting information and technical requirements for electronic documents and means of electronic communication in a public procurement or design contest procedure (Journal of Laws of 2020, item 2452), issued pursuant to Art. 70 of the Public Procurement Law 2.6. The Contracting Authority permits the documents referred to in points 2.1.1.-2.1.6. and points 2.2.1.-2.2.2. to be submitted in Polish or English without the need for translation Procedure: open. Estimated value: 49,583.33 PLN. Review the original TED notice for the complete requirement, lots, amendments and attachments.