Supply of reagents with lease of hematological analyzers and reagents for immunochemical tests. Order. declares that, being a data controller and taking into account the provisions of the Act of 10.5.2018 on the protection of personal data (hereinafter referred to as GDPR), it has implemented security measures adequate to the risks identified by it and guaranteeing proper protection of personal data provided as part of the proceedings. A detailed information clause from Article 13 of the GDPR is included in the SWZ. Order. does not require a deposit. Order. does not provide for the possibility of awarding contracts referred to in Article 214(1)(8). provides for the application of the so-called reverse procedure referred to in Article 139(1) of the PPL.

A detailed description and manner of performance of the order is contained in Annexes 2,3 and 4 to SWZ.1.The Ordering Party requests that the following means of evidence be submitted together with the offer under pain of nullity in electronic form to confirm that the offered supplies meet the requirements specified by the Ordering Party:

1) Dot. Part No. 1 - Part of the instructions for use and/or technical specification of the device (analyzer) drawn up by the manufacturer of the device confirming the technical parameters specified in OPZ - Appendix. No. 3 to SWZ (regarding part No. 1).

2) Dot. Part No. 1 - Current document confirming marketing authorization and for use as a medical device meeting the requirements within the meaning of the Act of 07.04.2022. on medical devices (Journal of Laws of 2022, item 974) and Directive 93/42/EEC or compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / (EU) 2017/46 on in vitro medical devices, bearing the CE marking of the product - i.e. a declaration of conformity and/or an EU certificate issued by the manufacturer or an authorized / authorized representative confirming that the product complies with the essential requirements. or: Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading and use in the Polish in accordance with applicable regulations in the event that the subject of the contract described in the SWZ has not been classified as a medical device.

2. If the Contractor does not submit the evidence in question or the measures of evidence submitted are incomplete, the Contracting Authority shall call for submission or supplement them within the time limit set.

I. In order to demonstrate the absence of grounds for exclusion and to meet the conditions for participation in the procurement procedure, the Contractor shall attach to the offer a statement of the ESPD in for. electronic – detailed requirements are included in the SWZ and Appendix. No. 6a to SWZ (regarding the grounds for exclusion on Article 7(1) of the Act of 13.04.2022, i.e. Journal of Laws of 2023, item 1497, as amended) and Article 5 k of Regulation 833/2014 as amended by Regulation (EU) 2022/576 (Journal of Laws of 2022). EU No L 111, 8.4.2022, p. 1) referred to in Chapter VIII (5) and (6) SWZ).

A detailed description and method of execution of the order is contained in Annexes 2, 3 and 4 to the SWZ. 1.The Ordering Party requests that the following electronic means of proof be submitted together with the offer under pain of nullity to confirm that the offered supplies meet the requirements specified by the Ordering Party:2) Dot. Part No. 2 - Current document confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07.04.2022. on medical devices (Journal of Laws of 2022, item 974) and Directive 93/42/EEC or compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / (EU) 2017/46 on in vitro medical devices, bearing the CE marking of the product - i.e. a declaration of conformity and/or an EU certificate issued by the manufacturer or an authorized / authorized representative confirming that the product complies with the essential requirements. or: Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading and use in the Polish in accordance with applicable regulations in the event that the subject of the contract described in the SWZ has not been classified as a medical device.

2. If the Contractor does not submit the means of evidence in question or the evidence submitted in question are incomplete, the Contracting Authority shall call for them to be lodged or supplemented within the deadline set.

I. In order to demonstrate the absence of grounds for exclusion and to meet the conditions for participation in the procurement procedure, the Contractor shall attach to the offer a statement of the ESPD in for. electronic – detailed requirements are included in the SWZ and Appendix. No. 6a to SWZ (regarding the grounds for exclusion on Article 7(1) of the Act of 13.04.2022, i.e. Journal of Laws of 2023, item 1497, as amended) and Article 5 k of Regulation 833/2014 as amended by Regulation (EU) 2022/576 (Journal of Laws of 2022). EU No L 111, 8.4.2022, p. 1) referred to in Chapter VIII (5) and (6) SWZ).