Poland – Diagnostics and radiodiagnostic devices and supplies – Dostawa wyrobów radiodiagnostycznych, do chirurgii naczyń i kardiochirurgii do Wojewódzkiego Szpitala Specjalistycznego im. Stefana Kardynała Wyszyńskiego SP ZOZ w Lublinie

The subject of the contract is the supply of radiodiagnostic products for vascular surgery (package no. 1-23) and cardiothoracic surgery (package no. 24) to the Stefan Cardinal Wyszyński Specialised Voivodeship Hospital SP ZOZ in Lublin, in accordance with the details in the assortment-price form, which is Annex no. 3 to the SWZ (packages no. 1-24). 2. The subject of the contract offered by the Contractor must have characteristics in accordance with the description contained in the assortment-price form, which is Annex no. 3 to the SWZ, and must meet the conditions specified in this SWZ. Failure to meet any of the specified requirements will result in the rejection of the offer. 3. Place of delivery: Warehouse, located at Al. Kraśnickiej 100 (deliveries) or directly to the Department of Vascular Surgery, Imaging and Interventional Radiology, Cardiothoracic Surgery (deposit). 4. The offered medical devices must be approved for sale and use in Poland in accordance with the applicable legal provisions and must have documents confirming the completion of the appropriate conformity assessment procedure in accordance with the requirements specified in the Act of 7 April 2022 on medical devices (i.e. Journal of Laws of 2024, item 1620) and be marked with the CE mark. 5. The subject of the contract covers the supply of medical devices within the meaning of the CPV code from 33100000-1 to 33199000-1, with an estimated value of at least 5,000,000 EUR net. The provisions of the European Parliament and Council Regulation (EU) 2022/1031 of 23 June 2022 on the access of operators, goods and services from third countries to the Union's public procurement and concession markets and procedures supporting negotiations on access to third country public procurement and concession markets for Union operators, goods and services (International Procurement Instrument – IPI) and the Commission Implementing Regulation (EU) 2025/1197 of 19 June 2025 imposing a measure of the International Procurement Instrument limiting the access of operators and medical devices originating in the People's Republic of China to the Union's public procurement market for medical devices in accordance with this Regulation, to the extent that this procedure covers medical devices subject to this Regulation. Detailed provisions in this respect are set out in Section V, point 4 of the SWZ. 5. The subject of the contract has been divided into parts. The Contracting Authority allows the submission of partial offers. The Contractor may submit an offer for any part/parts or for the entire subject of the contract. 6. The subject of the contract is also leasing (package no. 3, 7, 9) and the loan of equipment (package no. 11). Equipment requirements: equipment not older than the year of manufacture 2025. The cost of technical and servicing is borne by the Contractor – for package no. 3, 7, 9, 11. The loan agreement is Annex no. 4a to the SWZ, and the lease agreement is Annex no. 4b to the SWZ. 7. The provisions of the European Parliament and Council Regulation (EU) 2019/881 of 17 April 2019 on ICT products, ICT services and ICT processes, hereinafter jointly referred to as "ICT Elements", do not apply in this procedure. THE OFFER MUST INCLUDE THE FOLLOWING DECLARATIONS AND DOCUMENTS: 1) JEDZ Declaration - Annex no. 1 to the SWZ 2) Correctly completed Offer Form, prepared according to the template which is Annex no. 2 to the SWZ; 3) Correctly completed assortment-price forms, in accordance with Annex no. 3 to the SWZ – for each of the packages for which the Contractor submits an offer (including it is recommended to attach an editable version for calculation purposes); 4) Contractor's declaration regarding exclusion grounds – Annex no. 7 to the SWZ 5) Subject evidence, in accordance with the details in Section V, point 25 of the SWZ. 6) Power of attorney specifying the scope of authorisation and signed by persons authorised to represent the Contractor – if the Contractor seeking to be awarded the contract is represented by an agent; 7) Power of attorney to represent Contractors jointly seeking to be awarded the contract – if applicable.