Poland – Orthopaedic implants – Dostawy endoprotez, innych implantów ortopedycznych, substytutów kości do magazynu szpitala przez okres 24 miesięcy

The subject of the contract is the supply of endoprostheses, other orthopaedic implants, and bone substitutes to the hospital warehouse for a period of 24 months. 2. The contract has been divided into 7 lots. 3. The detailed description of the subject of the contract contains a form which is Annex 1A to the 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 understood that the indicated patents, trademarks, origin, and processes define the technical, operational, and user parameters, which means that the Contracting Authority 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 (EU) 2025/1197 of the European Parliament and of the Council of 19 June 2025 imposing the International Procurement Instrument limiting the access of contractors and medical devices from the People's Republic of China to the Union's public procurement market for medical devices in accordance with Regulation (EU) 2022/1031 of the European Parliament and of the Council 2) Regulation (EU) 2022/1031 of the European Parliament and of the Council 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 the negotiations on the access of Union contractors, goods and services to public procurement and concession markets of third countries (International Procurement Instrument - IPI) The Contracting Authority informs that the value of the contract awarded in parts in separate procedures and with a division into parts exceeds the amount of 10,000,000 euro expressed in złoty for supplies. VIII LIST OF SUBJECT MATTER PROOF 1. The Contracting Authority, in order to confirm the conformity of the offered supplies, requires the submission of the following subject matter proofs 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 catalog 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 catalog numbers/catalog groups or another identifier of the offered assortment. ** The Contracting Authority allows the possibility of submitting catalogs issued by an authorized representative/distributor of the producer in Poland with the offer 2. Subject matter proofs drawn up in a foreign language shall be submitted together with a translation into Polish. 3. The Contracting Authority requires that the subject matter proofs be drawn up in electronic form and signed with a qualified signature by the Contractor. 4. In the event that the subject matter proofs have been drawn up in electronic form and signed with a qualified signature by their issuer (authorized entity), they should be submitted in that form. 5. In the event that the subject matter proofs 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 subject matter proofs with the offer or the submitted subject matter proofs are incomplete, the Contracting Authority will call for their submission or completion within the specified deadline. 8. The Contracting Authority requires that the subject matter proofs confirm the actual state as of the date of submission of the offers. 9. The Contracting Authority requires that the subject matter proofs be 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 1 and 1A to the SWZ 2) JEDZ document - according to the template constituting Annex 2 to the SWZ. 3) Declaration on the origin of medical devices - according to the template constituting Annex 2B to the SWZ. 4) Subject matter proofs, as referred to in Section VIII of the SWZ 5) Power of attorney (if applicable) NOTE!!! Annexes 1 and 1A to the SWZ constitute the content of the offer and, as a result, are not subject to supplementation. The lack of these documents constitutes the invalidity of the submitted offer List of declarations submitted with the offer: 1) Declaration of the absence of grounds for exclusion drawn up in the form of the European Single Procurement Document (ESPD) - according to the template constituting Annex 2 to the SWZ. The Contracting Authority 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 prove the absence of grounds for exclusion of each of the contractors. 2) The Contracting Authority informs that the Contractor may use the document (ESPD) submitted in a separate procedure for the award of a contract, if it confirms that the information contained therein remains correct. 3) Declaration of the Contractor that it is not subject to exclusion under 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 1 to the SWZ 4) Declaration of the Contractor on the origin of medical devices - according to the template constituting Annex 2B to the SWZ