Deliveries of endoprostheses and other orthopedic implants to the hospital warehouse for a period of 24 months

The Independent Public Clinical Hospital named after Prof. A. Gruca CMKP in Poland from Europe region has released this tender for 1. The subject of the order is the delivery of endoprostheses and other orthopedic implants to the hospital warehouse for a period of 24 months. 2. The order has been divided into nine packages. 3. A detailed description of the subject of the order is included in the form constituting Appendix 1A to the Technical Specifications. If the description of the subject of the order indicates any trademark, patent, origin, source, or specific process that characterizes the products or services provided by a specific contractor, it should be assumed that the indicated patents, trademarks, origin, or processes determine the technical, operational, and functional parameters, which means that the Ordering Party allows the submission of an offer for this part of the subject of the order with equivalent technical, operational, and functional parameters. The provisions of: 1) Regulation (EU) 2025/1197 of the European Parliament and of the Council of 19 June 2025 imposing an International Procurement Instrument measure restricting the access of economic operators and medical devices originating in the Peoples Republic of China to the Union 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 access of economic operators, goods and services from third countries to Union public procurement and concessions markets and procedures supporting negotiations on access of Union economic operators, goods and services to third-country public procurement and concessions markets (International Procurement Instrument - IZM) The Contracting Authority informs that the value of the contract awarded in parts in separate procedures and divided into lots exceeds the zloty equivalent of EUR 10 000 000 for supplies. VIII LIST OF SUBJECT EVIDENCE 1. In order to confirm the compliance of the offered supplies, the Ordering Party requests the submission of the following subject evidence together with the offer: 1) A declaration that the offered assortment has been admitted and introduced to the market in accordance with the provisions of the Act of 7 April 2022 on medical devices and has valid declarations of conformity and certificates of a notified body * content of the declaration included in the offer form 2) Manufacturers catalog cards and/or operating techniques and/or other manufacturers materials confirming the parameters required in the description of the subject of the order, containing catalog numbers/groups of catalog numbers or another identifier of the offered assortment. * *The Ordering Party allows the possibility of submitting, along with the offer, catalogues issued by an authorized representative/distributor of the manufacturer in Poland. 2. The evidence in question prepared in a foreign language shall be submitted together with a translation into Polish. 3. The Ordering Party requires that the evidence in question be prepared in electronic form and signed with a qualified signature by the Contractor.4. If the evidence in question was prepared in electronic form and bearing a qualified signature by its issuer (authorized entity), it must be submitted in this form. 5. If the evidence in question was issued in paper form, a digital copy of the document bearing a qualified signature by the contractor must be submitted. 6. If any of the required documents submitted by the contractor is prepared in a foreign language, such document must be submitted together with a Polish translation. 7. If the contractor fails to submit the evidence in question with the offer, or the evidence submitted is incomplete, the contracting authority will request its submission or supplementation within a specified time. 8. The contracting authority requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The contracting authority requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF OFFER PREPARATION 1. The Contractor is obliged to submit, on the offer submission date: 1) A pricing form and an offer form using the templates constituting Appendices No. 1 and 1A to the ToR 2) An ESPD document - according to the template constituting Appendix No. 2 to the ToR. 3) A declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the ToR. 4) The relevant evidence referred to in chapter VIII of the ToR 5) A power of attorney (if applicable) ATTENTION!!! Appendices No. 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) A declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix No. 2 to the ToR. The Ordering Party informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of tenders. b) The declaration is submitted by each contractor jointly applying for the contract. The declaration is intended to demonstrate that there are no grounds for excluding any of the contractors. 2) The Ordering Party informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) The Contractors declaration that it is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration is included in the tender form constituting Appendix No. 1 to the ToR. 4) The Contractors declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the ToR.If the evidence in question was prepared in electronic form and bearing a qualified signature by its issuer (authorized entity), it must be submitted in this form. 5. If the evidence in question was issued in paper form, a digital copy of the document bearing a qualified signature by the contractor must be submitted. 6. If any of the required documents submitted by the contractor is prepared in a foreign language, such document must be submitted together with a translation into Polish. 7. If the contractor fails to submit the evidence in question with the offer, or the evidence submitted is incomplete, the ordering party will request its submission or supplementation within a specified time. 8. The ordering party requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The ordering party requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF OFFER PREPARATION 1. The Contractor is obliged to submit, on the offer submission date: 1) A pricing form and an offer form using the templates constituting Appendices No. 1 and 1A to the ToR 2) An ESPD document - according to the template constituting Appendix No. 2 to the ToR. 3) A declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the ToR. 4) The relevant evidence referred to in chapter VIII of the ToR 5) A power of attorney (if applicable) ATTENTION!!! Appendices No. 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) A declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix No. 2 to the ToR. The Ordering Party informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of tenders. b) The declaration is submitted by each contractor jointly applying for the contract. The declaration is intended to demonstrate that there are no grounds for excluding any of the contractors. 2) The Ordering Party informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) The Contractors declaration that it is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration is included in the tender form constituting Appendix No. 1 to the ToR. 4) The Contractors declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the ToR.If the evidence in question was prepared in electronic form and bearing a qualified signature by its issuer (authorized entity), it must be submitted in this form. 5. If the evidence in question was issued in paper form, a digital copy of the document bearing a qualified signature by the contractor must be submitted. 6. If any of the required documents submitted by the contractor is prepared in a foreign language, such document must be submitted together with a translation into Polish. 7. If the contractor fails to submit the evidence in question with the offer, or the evidence submitted is incomplete, the ordering party will request its submission or supplementation within a specified time. 8. The ordering party requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The ordering party requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF OFFER PREPARATION 1. The Contractor is obliged to submit, on the offer submission date: 1) A pricing form and an offer form using the templates constituting Appendices No. 1 and 1A to the ToR 2) An ESPD document - according to the template constituting Appendix No. 2 to the ToR. 3) A declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the ToR. 4) The relevant evidence referred to in chapter VIII of the ToR 5) A power of attorney (if applicable) ATTENTION!!! Appendices No. 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) A declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix No. 2 to the ToR. The Ordering Party informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of tenders. b) The declaration is submitted by each contractor jointly applying for the contract. The declaration is intended to demonstrate that there are no grounds for excluding any of the contractors. 2) The Ordering Party informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) The Contractors declaration that it is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration is included in the tender form constituting Appendix No. 1 to the ToR. 4) The Contractors declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the ToR.If the evidence in question was issued in paper form, a digital copy of the document must be provided with a qualified signature by the contractor. 6. If any of the required documents submitted by the contractor is drawn up in a foreign language, such document must be submitted together with a translation into Polish. 7. If the contractor fails to submit the evidence in question with the offer, or the evidence submitted is incomplete, the ordering party will request its submission or supplementation within a specified deadline. 8. The ordering party requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The ordering party requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF BID PREPARATION 1. The contractor is obligated to submit, on the offer submission date: 1) A pricing form and an offer form using the templates constituting Appendices No. 1 and 1A to the tender documentation. 2) The ESPD document - according to the template constituting Appendix No. 2 to the tender documentation. 3) Declaration regarding the origin of medical devices - according to the template constituting Appendix 2B to the ToR. 4) The relevant means of evidence referred to in Chapter VIII of the ToR 5) Power of attorney (if applicable) PLEASE NOTE!!! Appendices 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents will invalidate the submitted offer. List of declarations submitted with the offer: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix 2 to the ToR. The Contracting Authority hereby informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) This declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of offers. b) This declaration is submitted by each of the contractors jointly applying for the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of each contractor. 2) The Ordering Party informs that the Contractor may use the document (ESPD) submitted in a separate procurement procedure if it confirms that the information contained therein remains correct. 3) The Contractors declaration that it is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration is included in the tender form constituting Annex No. 1 to the Technical Specifications. 4) The Contractors declaration regarding the origin of medical devices - according to the template constituting Annex No. 2B to the Technical Specifications.If the evidence in question was issued in paper form, a digital copy of the document must be provided with a qualified signature by the contractor. 6. If any of the required documents submitted by the contractor is drawn up in a foreign language, such document must be submitted together with a translation into Polish. 7. If the contractor fails to submit the evidence in question with the offer, or the evidence submitted is incomplete, the ordering party will request its submission or supplementation within a specified deadline. 8. The ordering party requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The ordering party requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF BID PREPARATION 1. The contractor is obligated to submit, on the offer submission date: 1) A pricing form and an offer form using the templates constituting Appendices No. 1 and 1A to the tender documentation. 2) The ESPD document - according to the template constituting Appendix No. 2 to the tender documentation. 3) Declaration regarding the origin of medical devices - according to the template constituting Appendix 2B to the ToR. 4) The relevant means of evidence referred to in Chapter VIII of the ToR 5) Power of attorney (if applicable) PLEASE NOTE!!! Appendices 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents will invalidate the submitted offer. List of declarations submitted with the offer: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix 2 to the ToR. The Contracting Authority hereby informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) This declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of offers. b) This declaration is submitted by each of the contractors jointly applying for the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of each contractor. 2) The Ordering Party informs that the Contractor may use the document (ESPD) submitted in a separate procurement procedure if it confirms that the information contained therein remains correct. 3) The Contractors declaration that it is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration is included in the tender form constituting Annex No. 1 to the Technical Specifications. 4) The Contractors declaration regarding the origin of medical devices - according to the template constituting Annex No. 2B to the Technical Specifications.If the Contractor fails to submit the evidence in question with the offer or the evidence submitted is incomplete, the Ordering Party will request its submission or supplementation within a specified time limit. 8. The Ordering Party requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The Ordering Party requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF PREPARING THE OFFER 1. The Contractor is obliged to submit, as of the offer submission date: 1) Price form and offer form using the templates constituting Appendices No. 1 and 1A to the Technical Specifications (SWZ). 2) ESPD document - according to the template constituting Appendix No. 2 to the Technical Specifications (SWZ). 3) Declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the Technical Specifications (SWZ). 4) The evidence in question referred to in Chapter VIII of the Technical Specifications (SWZ). 5) Power of attorney (if applicable). ATTENTION!!! Appendices No. 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix No. 2 to the ToR. The Contracting Authority hereby informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of offers. b) The declaration is submitted by each of the contractors jointly applying for the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of each of the contractors. 2) The Contracting Authority hereby informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) Declaration by the Contractor that it is not subject to exclusion under Art. 7 sec. 1 of the Sanctions Act and Art. 5k. EU Regulation - content of the declaration included in the offer form constituting Annex No. 1 to the Technical Specifications 4) Contractors declaration regarding the origin of medical devices - according to the template constituting Annex No. 2B to the Technical SpecificationsIf the Contractor fails to submit the evidence in question with the offer or the evidence submitted is incomplete, the Ordering Party will request its submission or supplementation within a specified time limit. 8. The Ordering Party requires that the evidence in question confirm the factual circumstances as of the date of offer submission. 9. The Ordering Party requires that the evidence in question be current as of the date of submission/supplementation. XII DESCRIPTION OF THE METHOD OF PREPARING THE OFFER 1. The Contractor is obliged to submit, as of the offer submission date: 1) Price form and offer form using the templates constituting Appendices No. 1 and 1A to the Technical Specifications (SWZ). 2) ESPD document - according to the template constituting Appendix No. 2 to the Technical Specifications (SWZ). 3) Declaration regarding the origin of medical devices - according to the template constituting Appendix No. 2B to the Technical Specifications (SWZ). 4) The evidence in question referred to in Chapter VIII of the Technical Specifications (SWZ). 5) Power of attorney (if applicable). ATTENTION!!! Appendices No. 1 and 1A to the ToR constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix No. 2 to the ToR. The Contracting Authority hereby informs that when completing the declaration on the ESPD form, the Contractor may also use the tool available at: https://espd.uzp.gov.pl/ a) The declaration constitutes preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of offers. b) The declaration is submitted by each of the contractors jointly applying for the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of each of the contractors. 2) The Contracting Authority hereby informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) Declaration by the Contractor that it is not subject to exclusion under Art. 7 sec. 1 of the Sanctions Act and Art. 5k. EU Regulation - content of the declaration included in the offer form constituting Annex No. 1 to the Technical Specifications 4) Contractors declaration regarding the origin of medical devices - according to the template constituting Annex No. 2B to the Technical SpecificationsVIII STC 5) Power of Attorney (if applicable) PLEASE NOTE!!! Appendices 1 and 1A to the STC constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix 2 to the STC. The Contracting Authority hereby 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 preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of offers. b) The declaration is submitted by each contractor jointly applying for the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of each contractor. 2) The Contracting Authority hereby informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) Declaration of the Contractor that he is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration included in the offer form constituting Annex No. 1 to the Technical Specifications 4) Declaration of the Contractor regarding the origin of medical devices - according to the template constituting Annex No. 2B to the Technical SpecificationsVIII STC 5) Power of Attorney (if applicable) PLEASE NOTE!!! Appendices 1 and 1A to the STC constitute the content of the offer and therefore do not need to be supplemented. The absence of these documents constitutes the invalidity of the submitted offer. List of declarations submitted with the offer: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the Single European Procurement Document (ESPD) - according to the template constituting Appendix 2 to the STC. The Contracting Authority hereby 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 preliminary confirmation that the contractor is not subject to exclusion as of the date of submission of offers. b) The declaration is submitted by each contractor jointly applying for the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of each contractor. 2) The Contracting Authority hereby informs that the Contractor may use the document (ESPD) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) Declaration of the Contractor that he is not subject to exclusion under Article 7, Section 1 of the Sanctions Act and Article 5k of the EU Regulation - the content of the declaration included in the offer form constituting Annex No. 1 to the Technical Specifications 4) Declaration of the Contractor regarding the origin of medical devices - according to the template constituting Annex No. 2B to the Technical Specifications with tender notice no. 703896-2026 published on 12 Oct 2026. The tender is due to expire on 22 Oct 2026. This tender is sourced from TED Europa and is eligible for suppliers interested in Orthopaedic implants. Interested bidders can obtain further information including complete bid documents or ways to participate by registering on Tender Impulse and referencing via Tender Impulse ID 15409101.