Poland – Electrodes – Supply of electrodes for intra-articular ablation and coagulation compatible with the existing RF generator for the needs of the operating theatre for a period of 24 months

Opportunity description

1. The subject matter of the contract is the successive supply of electrodes for intra-articular ablation and coagulation compatible with the existing RF generator for the needs of the operating theatre for a period of 24 months 2. The scope of the contract includes the supply of electrodes for intra-articular ablation and coagulation, compatible with the existing AES-1 arthroscopic energy generator manufactured by Conmed. 2.1. All accessories offered should constitute a medical device. 2.2. The elements offered should be ready for direct use – sterile. 2.3. All accessories offered should bear the CE conformity marking. 3. A detailed description of the subject matter of the contract is contained in the price form constituting Annex No. 1A to the SWZ. 4. The Contractor is obliged to perform the contract in accordance with the rules and conditions described in the draft agreement constituting Annex No. 3 to the SWZ In order to confirm the compliance of the supplies offered, the Contracting Authority requires the following subject-matter evidence to be submitted together with the tender: 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) Catalogue sheets for the electrodes offered, together with drawings and catalogue numbers 2. Subject-matter evidence drawn up in a foreign language shall be submitted together with a translation into Polish 3. The Contracting Authority requires the subject-matter evidence to be drawn up in electronic form and furnished with the Contractor's qualified signature. 4. Where the subject-matter evidence has been drawn up in electronic form and furnished with the qualified signature of its issuer (authorised entity), it shall be submitted in that form. 5. Where the subject-matter evidence has been issued in paper form, a digital reproduction of the document furnished with the contractor's qualified signature shall be submitted 6. Where the Contractor does not submit the subject-matter evidence together with the tender or the subject-matter evidence submitted is incomplete, the Contracting Authority shall request its submission or supplementation within the specified time limit. 7. The Contracting Authority requires the subject-matter evidence to confirm the facts as at the tender submission date. 8. The Contracting Authority requires the subject-matter evidence to be current as at the date of submission/supplementation. 1) Declaration demonstrating the absence of grounds for exclusion from the procedure, drawn up 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 at the tender submission date. b) The declaration shall be submitted by each of the contractors jointly applying for the award of the contract. The declaration is intended to demonstrate the absence of grounds for exclusion of 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(1) of the Sanctions Act and Art. 5k of the EU Regulation – the content of the declaration is included in the tender form constituting Annex No. 1 to the SWZ XII DESCRIPTION OF THE METHOD OF PREPARING THE TENDER 1. The Contractor is obliged to submit, as at 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.