Poland – Hospital beds – SUPPLY OF HOSPITAL BEDS FOR SP ZOZ IN ŁĘCZNA

Opportunity description

3.1. The subject matter of the contract is the supply of hospital beds (electric) to SPZOZ in Łęczna. The subject matter of the contract has been described and specified in Annex No. 3 constituting the Specification of technical parameters, CPV code: 33192100-3 beds for medical use. 3.2. The subject matter of the contract must be new, authorized for marketing on the basis of applicable provisions of law and comply with all requirements laid down by provisions of law, in particular the Act of 7 April 2022 on medical devices (Journal of Laws 2024, item 1620), and be free from any physical or legal defects. 3.3. If the tender documentation indicates the trade name of a company, goods or product, the Contracting Authority permits equivalent solutions compliant with the technical data and parameters contained in the documentation. If the Contracting Authority permits solutions equivalent to those described in the documentation constituting an annex to the SWZ, but does not provide minimum parameters that would confirm such equivalence – the Contractor is obliged to offer a product with similar properties, functionally suitable for the required application (argument based on the operative part of the judgment of the National Appeals Chamber of 14 October 2013 [case reference: KIO 2315/13]). A Contractor that invokes solutions equivalent to those described by the Contracting Authority is obliged to demonstrate that the supplies it offers meet the requirements specified by the Contracting Authority. NOTE: A proper name is the name under which the item designated by it appears (or would appear) both in Poland and in other countries. 3.4. During the warranty period for the beds to which the warranty applies and which has been entered in the technical specification, the Contractor undertakes to provide servicing, validation and warranty services for the subject matter of the supply in accordance with the manufacturer’s recommendations, without the Contracting Authority incurring costs, provided that the minimum warranty conditions must correspond to the conditions specified in the table of warranty conditions and warranty service constituting 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 Art. 139 of the PZP – informs that it will first examine and evaluate the tenders in this public procurement procedure and will then perform the entity qualification of the contractor whose tender was rated highest, with regard to the absence of grounds for exclusion and fulfillment of the conditions for participation in the procedure. 5.7. The contract is being implemented as part of the project entitled “Project for the development and modernization of the critical infrastructure of SPZOZ in Łęczna in the event of a crisis situation or armed conflict” Measure 16.1 “Strengthening resilient healthcare infrastructure (project type 1,2) FELU.16.01-IZ.00-003/26” 5.8. If financial resources (a grant) are not received, the Contracting Authority reserves the right to invalidate the procedure due to a lack of funds to finance the contract. 5.9. The subject matter of the contract has not been divided into lots because, for technical and organizational reasons, it constitutes an inseparable whole. Furthermore, dividing the contract could cause excessive technical difficulties and increase the cost of performing the task due to costs being charged separately by each Contractor. In addition, dividing the contract into lots would not be appropriate due to the very significant difficulties associated with coordinating the activities of different contractors performing the individual parts of the contract, which could jeopardize the proper performance of the contract, as well as result in serious difficulties in enforcing the Contracting Authority’s rights associated with the warranty and statutory warranty granted by the Contractors for the individual parts of the subject matter of the contract. The contract does not restrict the participation of small and medium-sized enterprises in the procedure being conducted. 5.10. The Contracting Authority requires the manufacturer of the beds offered to have an implemented and maintained quality management system for medical devices, covering at least the manufacture of the type of devices offered and – where applicable to the scope of the manufacturer’s activities – their design. To confirm compliance with this requirement, the Contractor shall submit a certificate of conformity with ISO 13485:2016 or an equivalent certificate, valid on the deadline for submission of tenders and issued by an independent, accredited conformity assessment body. The scope of the certificate must cover the type of devices offered. A certificate confirming the use of a system covering at least the following shall be deemed equivalent: supervision of the production process, risk management, device traceability, control of nonconforming devices, handling of complaints and incidents, corrective and preventive actions, and supplier oversight. Other means of evidence may be accepted only in the circumstances specified in Art. 105(4) of the Pzp Act, after the Contractor has demonstrated that it lacks access to the required certificate for reasons not attributable to it and that the measures used are fully equivalent. 5.11. For each bed model offered, the Contractor shall submit: 5.11.1 An EU declaration of conformity drawn up by the manufacturer in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council and, in the case of a device benefiting from transitional provisions, a declaration of conformity drawn up in accordance with the provisions applicable to that device; 5.11.2. A document confirming that the device bears the CE marking, in particular a label, instructions for use 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 device class and the conformity assessment procedure applied pursuant to Regulation (EU) 2017/745 or the provisions applicable to a device benefiting from the transitional period; 5.11.4. In the case of a device benefiting from transitional provisions – documents other than the declaration of conformity indicated in point 5.11.1 confirming fulfillment of the conditions for legally placing this ...see SWZ Set No. 1 Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.