Poland – Medical consumables – Supply of sterile disposable equipment to the Pharmacy for a period of 24 months

Opportunity description

The contract has been divided into 30 packages. A detailed description of the subject matter of the contract is contained in the price form constituting Annex No. 1 A to the SWZ. The Contracting Authority requires the delivered goods to have information on the packaging about the use-by date/expiry date, with the proviso that the expiry date may not be shorter than 12 months from the date of delivery. VIII LIST OF SUBJECT-MATTER EVIDENCE 1) Declaration of conformity* – a document issued by the manufacturer of the device or its authorised representative. (applies to all classes of medical devices) 2) Certificate of conformity* – a document issued by a notified body in the field of medical devices, certifying that conformity assessment procedures have been carried out. (applies to medical devices classified as: Class I sterile, Class I with a measuring function, Class II A, IIb, III, and, in accordance with EU Directive 98/79, Class A and B devices) 3) Manufacturer’s catalogue sheets and/or other manufacturer’s materials* confirming all parameters required in the description of the subject matter of the contract, containing catalogue numbers and photographs/drawings of the offered assortment. The Contracting Authority permits catalogue sheets issued by the manufacturer’s direct importer/distributor in Poland to be submitted with the tender. *The Contracting Authority requires at least one of the above-mentioned documents to confirm the assortment’s compliance with the standards contained in the description of the subject matter of the contract in the price form. 4) Reference samples – 1 item each (package 7 item 4; 8 and package 27 items 1, 2, 3, 4, 5) 6. If the Contractor does not submit the subject-matter evidence with the tender or the submitted subject-matter evidence is incomplete, the Contracting Authority will request its submission or supplementation within the specified time limit. 7. The Contracting Authority requires the subject-matter evidence to confirm the facts as of the tender submission date. 8. The Contracting Authority requires the subject-matter evidence to be current as of the date of submission/supplementation. List of declarations submitted with the tender: 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, prepared in the form of the European Single Procurement Document (JEDZ) – according to the template constituting Annex No. 2 to the SWZ. The Contracting Authority informs that, when completing the declaration on the JEDZ 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 tender submission date, as applicable b) The declaration shall be submitted by each contractor jointly applying for the award of the contract. The declaration is intended to demonstrate the absence of grounds for excluding each contractor. 2) The Contracting Authority informs that the Contractor may use a document (JEDZ) submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) Declaration that the contractor is not subject to exclusion pursuant to Art. 7 sec. 1 of the Sanctions Act and Art. 5k of the EU Regulation – the content of the declaration is included in the tender form (Annex No. 1 to the SWZ) Chapter XII of the SWZ DESCRIPTION OF THE METHOD OF PREPARING THE TENDER 1. The Contractor is required to submit, as of the tender submission date: a) Tender form using the template constituting Annex No. 1 to the SWZ b) Price form using the template constituting Annex No. 1A to the SWZ. c) Contractor’s declaration (JEDZ) – according to the template constituting Annex No. 2 to the SWZ. d) Declaration demonstrating the absence of grounds for exclusion under the Sanctions Act – the content of the declaration is included in the tender form. e) Subject-matter evidence referred to in Chapter VIII of the SWZ f) Power of attorney (if applicable) ATTENTION!!! Annexes No. 1 and 1A to the SWZ constitute the content of the tender and therefore may not be supplemented. The absence of these documents renders the submitted tender invalid. A detailed description of the subject matter of the contract is contained in the price form constituting Annex No. 1 A to the SWZ. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.