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 contract covers the supply of electrodes for intra-articular ablation and coagulation, compatible with the existing Conmed AES-1 arthroscopic energy generator. 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 Appendix No. 1A to the SWZ. 4. The Contractor is obliged to perform the contract in accordance with the rules and conditions described in the model contract constituting Appendix No. 3 to the SWZ In order to confirm the conformity of the supplies offered, the Contracting Authority requires the following subject-matter evidence to be submitted with the tender: 1) Declaration of conformity – a document issued by the device manufacturer 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 affixed with the Contractor's qualified signature. 4. Where the subject-matter evidence has been drawn up in electronic form and affixed 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 affixed with the contractor's qualified signature shall be submitted 6. Where the Contractor does not submit the subject-matter evidence with the tender or the submitted subject-matter evidence is incomplete, the Contracting Authority will call for its submission or supplementation within a specified time limit. 7. The Contracting Authority requires the subject-matter evidence to confirm the factual state 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 (ESPD) – according to the template constituting Appendix No. 2 to the SWZ. The Contracting Authority informs that, when completing the declaration on the ESPD 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 an ESPD document submitted in a separate contract award procedure if it confirms that the information contained therein remains correct. 3) When completing the ESPD form, the Contractor: a) Part I (Information concerning the procurement procedure and the contracting authority or contracting entity) – is required to complete it, b) Part II (Information concerning the contractor) – is required to complete it to the extent applicable to the requirements specified by the Contracting Authority in this procedure, NOTE: The contractor shall include information about the certificate in Part II, Section A, in the field concerning entry in an official list of approved contractors or possession of an equivalent certificate. The Contractor should provide data enabling:  identification of the certificate;  determination of the certifying entity;  retrieval of the certificate in the database;  determination of the scope in which the contractor intends to use it. c) with regard to Part III (Grounds for exclusion), the contractor completes the fields of the ESPD form indicated by the contracting authority, d) Part IV (Selection criteria) the contractor does not complete this part e) Part V the contractor does not complete this part f) Part VI (Concluding statements) the contractor is required to complete. 4) Declaration that the contractor is not subject to exclusion pursuant to Article 7(1) of the Sanctions Act and Article 5k of the EU Regulation – the content of the declaration is included in the tender form constituting Appendix No. 1 to the SWZ 5) The absence of grounds for exclusion may be demonstrated by: a) entity-related evidence indicated in VII 2.2 of the SWZ or b) a valid contractor certificate, if the content of the certificate confirms the absence of grounds for exclusion from the procedure to the extent required by the contracting authority, and the data contained in the ESPD submitted with the tender and in the tender enable the contracting authority to identify the certificate and obtain it independently. XII DESCRIPTION OF THE METHOD OF PREPARING THE TENDER 1. The Contractor is required to submit, as at the tender submission date: a) Tender form using the template constituting Appendix No. 1 to the SWZ b) Price form using the template constituting Appendix No. 1A to the SWZ. c) Contractor's declaration (ESPD) – according to the template constituting Appendix 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 A detailed description of the subject matter of the contract is contained in the price form constituting Appendix No. 1 A to the SWZ. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.