Poland – Orthopaedic implants – Dostawy innych implantów ortopedycznych, cementów kostnych, pozostałych wyrobów medycznych do magazynu szpitala przez okres 24 miesięcy

The subject of the contract is the supply of other orthopaedic implants, bone cements, remaining medical products to the hospital's warehouse for a period of 24 months. 2. The order has been divided into 7 lots. 3. A detailed description of the subject of the contract contains a form constituting Annex No. 1A to SWZ. If any trademark, patent or origin, source or special process that characterizes the products or services provided by a specific contractor is indicated in the description of the subject of the contract – it should be assumed that the indicated patents, trademarks, origin, processes define the technical, operational, and user parameters, which means that the Purchaser allows the submission of an offer in this part of the subject of the contract with equivalent technical, operational and user parameters. The following regulations apply to this procedure: 1) Regulation of the European Parliament and of the Council (EU) 2025/1197 of 19 June 2025 imposing the International Procurement Instrument restricting the access of contractors and medical products from the People's Republic of China to the Union's public procurement market for medical products in accordance with Regulation (EU) 2022/1031 of the European Parliament and of the Council 2) Regulation of the European Parliament and of the Council (EU) 2022/1031 of 23 June 2022 on the access of contractors, goods and services from third countries to Union public procurement and concession markets and procedures supporting negotiations on the access of Union contractors, goods and services to third country public procurement and concession markets (International Procurement Instrument - IPI) The Purchaser informs that the value of the order awarded in parts in separate procedures and with division into parts exceeds the amount of 10,000,000 euro expressed in zlotys for supplies. VIII LIST OF SUBSTANTIVE EVIDENTIARY MEANS 1. The Purchaser, in order to confirm the compliance of the offered supplies, requires the submission of the following substantive evidentiary means together with the offer: 1) A declaration that the offered assortment has been approved and placed on the market in accordance with the provisions of the Act of 7 April 2022 on medical devices and has current declarations of conformity and certificates of the notified body * the content of the declaration is contained in the offer form 2) Producer's catalogue cards and/or operating techniques and/or other producer's materials confirming the parameters required in the description of the subject of the contract, containing catalogue numbers/catalogue groups or another identifier of the offered assortment. *** The Purchaser allows the possibility of submitting catalogues issued by an authorized representative/distributor of the producer in Poland together with the offer 2. Substantive evidentiary means drawn up in a foreign language are to be submitted together with a translation into Polish. 3. The Purchaser requires that the substantive evidentiary means be drawn up in electronic form and signed with a qualified signature by the Contractor. 4. In the event that the substantive evidentiary means have been drawn up in electronic form and signed with a qualified signature by their issuer (authorized entity), they should be submitted in such form. 5. In the case where the substantive evidentiary means have been issued in paper form, a digital copy of the document signed with a qualified signature by the contractor should be submitted. 6. If any of the required documents submitted by the Contractor is drawn up in a foreign language, such a document should be submitted together with a translation into Polish. 7. In the event that the Contractor does not submit the substantive evidentiary means together with the offer or the submitted substantive evidentiary means are incomplete, the Purchaser will call for their submission or completion within the specified deadline. 8. The Purchaser requires that the substantive evidentiary means confirm the factual status as of the date of submission of the offers. 9. The Purchaser requires that the substantive evidentiary means are up-to-date as of the date of submission/completion. XII DESCRIPTION OF THE METHOD OF PREPARING THE OFFER 1. The Contractor is obliged to submit on the date of submission of the offers: 1) Price form and offer form using the templates constituting Annexes No. 1 and 1A to SWZ 2) JEDZ document - according to the template constituting Annex No. 2 to SWZ. 3) Declaration regarding the origin of medical devices - according to the template constituting Annex No. 2B to SWZ. 4) Substantive evidentiary means, as referred to in Section VIII SWZ 5) Power of attorney (if applicable) NOTE!!! Annexes No. 1 and 1A to SWZ constitute the content of the offer and, consequently, are not subject to supplementation. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted together with the offer: 1) Declaration of the absence of grounds for exclusion from the procedure drawn up in the form of the European Single Procurement Document (ESPD) - according to the template constituting Annex No. 2 to SWZ. The Purchaser informs that the Contractor, when completing the declaration on the ESPD form, may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes a preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of the offers b) The declaration is submitted by each of the contractors jointly applying for the award of the contract. The declaration must demonstrate the absence of grounds for exclusion of each of the contractors. 2) The Purchaser informs that the Contractor may use the document (ESPD) submitted in a separate procedure for the award of the contract, if it confirms that the information contained therein remains correct. 3) Declaration of the Contractor that it is not subject to exclusion on the basis of Article 7(1) of the Sanctions Act and Article 5k of Regulation (EU) - the content of the declaration is contained in the offer form constituting Annex No. 1 to SWZ 4) Declaration of the Contractor regarding the origin of medical devices - according to the template constituting Annex No. 2B to SWZ.