Poland – Disposable non-chemical medical consumables and haematological consumables – “Supply of disposable products divided into 18 packages for patients of the Independent Public Complex of Healthcare Institutions named after the Children of Warsaw in Dziekanów Leśny”.

Opportunity description

1. The subject matter of the contract is the supply of disposable products divided into 18 packages for patients of the Independent Public Complex of Healthcare Institutions named after the Children of Warsaw in Dziekanów Leśny”.”. 2. A detailed description of the subject matter of the contract is contained in this SWZ and: 1) Annex No. 1 – tender form; 2) Annex No. 2 – assortment and price form, which also constitutes the description of the subject matter of the contract; 3) Annex No. 4 – draft contract; 3. The Contracting Authority permits the submission of tenders for parts. 4. The Contractor may submit a tender for all parts (packages/tasks) of the contract. The Contracting Authority does not limit the number of parts of the contract for which the Contractor may submit a tender and does not specify the maximum number of parts of the contract that may be awarded to one Contractor. 5. The contract has been divided into 18 parts/packages/tasks. 6. The Contracting Authority reserves the right not to perform the contract in full with respect to a given part. The contract will be performed in accordance with the Contracting Authority’s current needs. However, the value of the parties’ performance will not be less than 70% of the total gross value of the Subject Matter of the Contract (for each part of the contract). The Contracting Authority does not require the Contractor to conduct a site visit before submitting a tender. 7. The Contracting Authority does not require payment of a tender security deposit. 8. The Contracting Authority does not envisage awarding the contracts referred to in Article 214(1)(8) of the Pzp Act. Additional information: 1. The Contracting Authority envisages applying the so-called reverse procedure referred to in Article 139(1) of the Pzp Act, i.e. the Contracting Authority will first examine and evaluate the tenders and will then perform the entity qualification of the Contractor whose tender received the highest evaluation with regard to the absence of grounds for exclusion and fulfilment of the conditions for participation in the procedure.2. The Contracting Authority will exclude from the procedure Contractors to whom the grounds for exclusion referred to in the following apply: 1)Article 108(1) of the Pzp Act, 2)Article 109(1)(4) of the Pzp Act,3)Article 7(1) of the Act of 13 April 2022 on special measures to counteract support for aggression against Ukraine and to protect national security (consolidated text: Journal of Laws of 2024, item 507). 3.The Contracting Authority will exclude from the procedure Contractors to whom the grounds specified in Article 5k of Council Regulation (EU) No 833/2014 of 31 July 2014 concerning restrictive measures in view of Russia’s actions destabilising the situation in Ukraine apply. 4. Required entity-related evidence – in accordance with Chapter X of the SWZ. 5. Information concerning Contractors jointly applying for the award of the contract and subcontractors – in accordance with Chapter XI of the SWZ. F. Information on subject-matter evidence – in accordance with Chapter VI of the SWZ. A detailed description of the subject matter of the contract is contained in this SWZ and:1)Annex No. 1 – tender form; 2)Annex No. 2 – assortment and price form, which also constitutes the description of the subject matter of the contract; 3)Annex No. 4 – draft contract. 1. All requirements specified in the SWZ and the documents indicated above constitute minimum requirements, and compliance with them is mandatory. Failure to meet the above-mentioned minimum requirements will result in rejection of the tender as non-compliant with the contract conditions pursuant to Article 226(1)(5) of the Pzp Act. 2. The Contracting Authority requires the Contractor to submit with the tender the following subject-matter evidence confirming that the supplies offered meet the requirements specified by the Contracting Authority in the SWZ (in particular in the description of the subject matter of the contract): 1) a current document confirming authorisation for placing on the market and use as a medical device meeting the requirements within the meaning of the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws of 2024, item 1620) and compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / Regulation (EU) 2017/746 on in vitro diagnostic medical devices, bearing the CE marking – i.e.: a declaration of conformity and/or certificate of conformity issued by the manufacturer or an authorised representative confirming that the device complies with the essential requirements; 2) a certificate from a notified body (identifying the manufacturer and type of device), if the assessment was carried out with the participation of a notified body (if an assessment by a notified body was required) – if applicable; 3) a statement by the Contractor confirming the notification/notice/application/entry of the offered medical device in the register of medical devices maintained by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) – the Contractor shall submit the statement on its own form; 4) information materials (brochure, catalogue, sheet, data form, part of the operating instructions/manufacturer’s description, statements and information or other materials defining the subject matter of the contract and its parameters, etc.) confirming the requirements contained in Annex No. 2 to the SWZ. 3.The Contracting Authority envisages the possibility of supplementing the subject-matter evidence if the Contractor does not submit the subject-matter evidence or if the submitted subject-matter evidence is incomplete. The Contractor may supplement the subject-matter evidence, but only at the request of the Contracting Authority. 4.In accordance with Article 107(2) of the Pzp Act, the Contracting Authority has the right to request that the Contractor submit or supplement, within a specified time limit, the subject-matter evidence indicated in paragraph 2 of the above-mentioned subject-matter evidence if the Contractor has not submitted the subject-matter evidence or the submitted subject-matter evidence is incomplete.5.The Contracting Authority accepts equivalent subject-matter evidence if it confirms that the performance offered meets the requirements, characteristics or criteria specified by the Contracting Authority. 6.The Contracting Authority envisages the possibility of asking the Contractor to clarify the subject-matter evidence. 7.The Contracting Authority will not request supplementation or clarification of the subject-matter evidence if the Contractor’s tender is subject to rejection irrespective of its submission or if there are grounds for cancelling the procedure. (Article 107(3) of the Pzp Act). A detailed description of the subject matter of the contract is contained in this SWZ and:1)Annex No. 1 – tender form; 2)Annex No. 2 – assortment and price form, which also constitutes the description of the subject matter of the contract; 3)Annex No. 4 – draft contract. 1. All requirements specified in the SWZ and the documents indicated above constitute minimum requirements, and compliance with them is mandatory. Failure to meet the above-mentioned minimum requirements will result in rejection of the tender as non-compliant with the contract conditions pursuant to Article 226(1)(5) of the Pzp Act. 2. The Contracting Authority requires the Contractor to submit with the tender the following subject-matter evidence confirming that the supplies offered meet the requirements specified by the Contracting Authority in the SWZ (in particular in the description of the subject matter of the contract): 1) a current document confirming authorisation for placing on the market and use as a medical device meeting the requirements within the meaning of the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws of 2024, item 1620) and compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / Regulation (EU) 2017/746 on in vitro diagnostic medical devices, bearing the CE marking – i.e.: a declaration of conformity and/or certificate of conformity issued by the manufacturer or an authorised representative confirming that the device complies with the essential requirements; 2) a certificate from a notified body (identifying the manufacturer and type of device), if the assessment was carried out with the participation of a notified body (if an assessment by a notified body was required) – if applicable; 3) a statement by the Contractor confirming the notification/notice/application/entry of the offered medical device in the register of medical devices maintained by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) – the Contractor shall submit the statement on its own form; 4) information materials (brochure, catalogue, sheet, data form, part of the operating instructions/manufacturer’s description, statements and information or other materials defining the subject matter of the contract and its parameters, etc.) confirming the requirements contained in Annex No. 2 to the SWZ. 5) with regard to package No. 12, item 2: samples – min. 1 unit of the offered filter, in accordance with the requirements specified in the assortment and price form. The samples must confirm that the assortment meets the minimum parameters specified by the Contracting Authorities in Annex No. 2 to the SWZ (for package No. 12, item 2); 3.The Contracting Authority envisages the possibility of supplementing the subject-matter evidence if the Contractor does not submit the subject-matter evidence or if the submitted subject-matter evidence is incomplete. The Contractor may supplement the subject-matter evidence, but only at the request of the Contracting Authority. 4.In accordance with Article 107(2) of the Pzp Act, the Contracting Authority has the right to request that the Contractor submit or supplement, within a specified time limit, the subject-matter evidence indicated in paragraph 2 of the above-mentioned subject-matter evidence if the Contractor has not submitted the subject-matter evidence or the submitted subject-matter evidence is incomplete.5.The Contracting Authority accepts equivalent subject-matter evidence if it confirms that the performance offered meets the requirements, characteristics or criteria specified by the Contracting Authority. 6.The Contracting Authority envisages the possibility of asking the Contractor to clarify the subject-matter evidence. 7.The Contracting Authority will not request supplementation or clarification of the subject-matter evidence if the Contractor’s tender is subject to rejection irrespective of its submission or if there are grounds for cancelling the procedure. (Article 107(3) of the Pzp Act). A detailed description of the subject matter of the contract is contained in this SWZ and:1)Annex No. 1 – tender form; 2)Annex No. 2 – assortment and price form, which also constitutes the description of the subject matter of the contract; 3)Annex No. 4 – draft contract. 1. All requirements specified in the SWZ and the documents indicated above constitute minimum requirements, and compliance with them is mandatory. Failure to meet the above-mentioned minimum requirements will result in rejection of the tender as non-compliant with the contract conditions pursuant to Article 226(1)(5) of the Pzp Act. 2. The Contracting Authority requires the Contractor to submit with the tender the following subject-matter evidence confirming that the supplies offered meet the requirements specified by the Contracting Authority in the SWZ (in particular in the description of the subject matter of the contract): 1) a current document confirming authorisation for placing on the market and use as a medical device meeting the requirements within the meaning of the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws of 2024, item 1620) and compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / Regulation (EU) 2017/746 on in vitro diagnostic medical devices, bearing the CE marking – i.e.: a declaration of conformity and/or certificate of conformity issued by the manufacturer or an authorised representative confirming that the device complies with the essential requirements; 2) a certificate from a notified body (identifying the manufacturer and type of device), if the assessment was carried out with the participation of a notified body (if an assessment by a notified body was required) – if applicable; 3) a statement by the Contractor confirming the notification/notice/application/entry of the offered medical device in the register of medical devices maintained by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) – the Contractor shall submit the statement on its own form; 4) information materials (brochure, catalogue, sheet, data form, part of the operating instructions/manufacturer’s description, statements and information or other materials defining the subject matter of the contract and its parameters, etc.) confirming the requirements contained in Annex No. 2 to the SWZ. 5) not applicable; 6) with regard to package No. 16: samples – min. 2 units of the offered filter, in accordance with the requirements specified in the assortment and price form. The samples must confirm that the assortment meets the minimum parameters specified by the Contracting Authorities in Annex No. 2 to the SWZ (for package No. 16); 3.The Contracting Authority envisages the possibility of supplementing the subject-matter evidence if the Contractor does not submit the subject-matter evidence or if the submitted subject-matter evidence is incomplete. The Contractor may supplement the subject-matter evidence, but only at the request of the Contracting Authority. 4.In accordance with Article 107(2) of the Pzp Act, the Contracting Authority has the right to request that the Contractor submit or supplement, within a specified time limit, the subject-matter evidence indicated in paragraph 2 of the above-mentioned subject-matter evidence if the Contractor has not submitted the subject-matter evidence or the submitted subject-matter evidence is incomplete.5.The Contracting Authority accepts equivalent subject-matter evidence if it confirms that the performance offered meets the requirements, characteristics or criteria specified by the Contracting Authority. 6.The Contracting Authority envisages the possibility of asking the Contractor to clarify the subject-matter evidence. 7.The Contracting Authority will not request supplementation or clarification of the subject-matter evidence if the Contractor’s tender is subject to rejection irrespective of its submission or if there are grounds for cancelling the procedure. (Article 107(3) of the Pzp Act). Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.