Poland – Hospital beds – DOSTAWA ŁÓŻEK SZPITALNYCH DLA SP ZOZ W ŁĘCZNEJ

3.1. The subject of the contract is the delivery of hospital beds (electric) to SPZOZ in Łęczna. The subject of the contract is described and specified in Annex No. 3, which is the Technical Parameter Specification, CPV code: 33192100-3 medical beds. 3.2. The subject of the contract must be new, allowed to be marketed in accordance with the applicable legal provisions, and meet all the requirements specified by the law, in particular the Act of 7 April 2022 on medical devices (Journal of Laws 2024 item 1620), and free from any physical or legal defects. 3.3. If a trade name, product name, or brand name is indicated in the tender documentation, the Contracting Authority allows equivalent solutions that comply with the technical data and parameters contained in the documentation. If the Contracting Authority allows equivalent solutions described in the documentation that is an annex to the SWZ, but does not provide the minimum parameters that would confirm this equivalence – the Contractor is obliged to offer a product with similar properties, suitable for the required application. (based on the judgment of the National Appeal Chamber of 14 October 2013 [case no.: KIO 2315/13]). A Contractor who refers to equivalent solutions described by the Contracting Authority is obliged to prove that the supplies offered by them meet the requirements specified by the Contracting Authority. NOTE: A trade name is a name under which the subject designated by it appears (or would appear) both in Poland and in other countries. 3.4. The Contractor undertakes, during the warranty period, to provide services for the beds, the warranty of which is covered and has been entered in the technical specification, for the purpose of servicing, validation and warranty of the subject of delivery in accordance with the manufacturer's recommendation, without incurring costs for the Contracting Authority, where the minimum warranty conditions must meet the conditions specified in the table of warranty and service conditions, which is Annex No. 12 to the SWZ. 3.5. The payment term is up to 60 days from the date of receipt of a correctly issued invoice. 3.6. The Contracting Authority – pursuant to Article 139 of the Public Procurement Law – informs that, in the first instance, it will examine and evaluate the offers in this public procurement procedure, and then qualify the Contractor, whose offer was the highest rated, in terms of the absence of exclusion grounds and meeting the conditions for participation in the procedure. 5.7. The contract is implemented as part of the project entitled "Project for the development and modernisation of critical SPZOZ infrastructure in Łęczna in the event of a crisis situation or armed conflict" Action 16.1 "Strengthening resilient health protection infrastructure (project type 1,2) FELU.16.01-IZ.00-003/26" 5.8. In the event of non-receipt of financial means (grant), the Contracting Authority reserves the right to invalidate the procedure due to lack of funds to finance the contract. 5.9. The subject of the contract is not divided into parts, as for technical and organisational reasons, it forms an indivisible whole. Furthermore, dividing the contract could cause excessive technical difficulties and increase the costs of implementing the task due to the allocation of costs by each Contractor individually. Additionally, dividing the contract into parts would not be appropriate due to the very large difficulties associated with coordinating the actions of different Contractors implementing individual parts of the contract, which could threaten the proper execution of the contract, as well as result in serious difficulties in enforcing the Contracting Authority's rights related to the warranty and guarantee given by the Contractors for individual parts of the subject of the contract. The contract does not limit the participation of small and medium-sized enterprises in the conducted procedure. 5.10. The Contracting Authority requires that the manufacturer of the offered beds has an implemented and maintained quality management system for medical devices, covering at least the production of the offered type of products and – if it concerns the scope of the manufacturer's activity – their design. To confirm the requirement, the Contractor submits a valid certificate of conformity with the ISO 13485:2016 standard or an equivalent certificate, issued by an independent, accredited conformity assessment body. The scope of the certificate must cover the offered type of products. An equivalent certificate will be considered a certificate confirming the application of a system covering at least: production process supervision, risk management, product traceability, non-conforming product supervision, complaint and incident handling, corrective and preventive actions, and supplier supervision. Other means of proof may be accepted exclusively in the circumstances specified in Article 105(4) of the Public Procurement Law, after the Contractor has demonstrated the lack of access to the required certificate due to reasons that cannot be attributed to them, and the full equivalence of the means used. 5.11. For each model of bed offered, the Contractor submits: 5.11.1. EU Declaration of Conformity prepared by the manufacturer in accordance with Regulation (EU) 2017/745, and in the case of a product using transitional provisions – a declaration of conformity prepared in accordance with the provisions applicable to that product; 5.11.2. A document confirming the marking of the product with the CE marking, in particular the label, user instructions or a photograph of the nameplate; 5.11.3. A valid certificate from a notified body – if the participation of a notified body is required due to the class of the product and the conformity assessment procedure applied on the basis of Regulation (EU) 2017/745 or the provisions applicable to the product using the transitional period; 5.11.4. In the case of a product using transitional provisions – documents, other than the declaration of conformity indicated in point 5.11.1, confirming compliance with the requirements for legal introduction of this... see SWZ