Poland – Operating-theatre devices – Supply of disposable blades for orthopedic saws compatible with the Stryker S6, S7, S8 and Stryker CD, Sabo, Stryker TPS systems for the Prof. A. Gruca Independent Public Clinical Hospital of the Centre of Postgraduate Medical Education in Otwock for a period of 24 months.

Opportunity description

1. The subject of the contract is the supply of disposable blades for orthopedic saws compatible with the Stryker S6, S7, S8 and Stryker CD, Sabo, Stryker TPS systems for the Prof. A. Gruca Independent Public Clinical Hospital of the Centre of Postgraduate Medical Education in Otwock for a period of 24 months. 2. The procedure constitutes one indivisible task. 2.1. General requirements a) Performance of the contract will take place over a period of 24 months from the date of signing the contract. b) The required assortment will be supplied solely on the basis of written orders, in the quantity specified in each order and in an assortment consistent with the catalogue numbers entered in the order and offered in the tender. c) The order completion time should not exceed 5 working days from the date the contractor receives the order. d) All accessories offered should bear the CE conformity marking. 3. A detailed description of the subject of the contract is contained in Annex No. 1A to the SWZ, i.e. the pricing form. 1. List of declarations submitted with the tender: 1) Declaration on meeting the conditions for participation in the procedure and 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 Annex 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 from the procedure 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) Declaration that it 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 Annex No. 1 to the SWZ. 1. 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 manufacturer of the product or its authorized 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 IIa, 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 source materials (e.g. folders, brochures) for the blades offered, together with drawings of the working part, available sizes and catalogue numbers. The document should contain at least: the manufacturer’s name, the blade catalogue number, the basic dimensions of the blade – a drawing of the blade or group of blades – applies to confirmation of the information provided in the pricing form (Annex No. 1A). The documents listed in subitems 1–3 are submitted to confirm the conformity of the assortment offered with the description of the subject of the contract. If the Contractor does not submit the subject-matter evidence with the tender or the subject-matter evidence submitted is incomplete, the Contracting Authority will request its submission or supplementation within the prescribed time limit. 4) Manufacturer’s catalogue sheets and/or other manufacturer’s source materials (e.g. folders, brochures) for the blades offered, containing all catalogue numbers specified in the pricing form (Tender evaluation criterion K2 – Number of different catalogue numbers of the blades offered for a given group of blades included in the pricing form constituting Annex No. 1A to the SWZ). The documents listed in subitem 4) are submitted to confirm the conformity of the assortment offered with the description of the parameters under evaluation criterion K2. The documents constitute an integral part of the tender and therefore may not be supplemented or submitted upon request. ** If a document confirming the value of a given parameter is not submitted with the tender, the Contractor will receive 0 points for that parameter. 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 electronic signature. 4. If the subject-matter evidence has been drawn up in electronic form and furnished with the qualified electronic signature of its issuer (authorized entity), it must be submitted in that form. 5. If the subject-matter evidence was issued in paper form, a digital reproduction of the document furnished with the contractor’s qualified electronic signature must be submitted. 6. The Contracting Authority requires the subject-matter evidence to confirm the actual state of affairs as at the tender submission date. 7. The Contracting Authority requires the subject-matter evidence to be current as at the date of submission/supplementation. 1. 1. The Contractor is required to submit the following as at the tender submission date: a) Tender form using the template constituting Annex No. 1 to the SWZ. b) Pricing form using the template constituting Annex No. 1A to the SWZ. c) Contractor’s declaration that it is not subject to exclusion (ESPD) – according to the template constituting Annex No. 2 to the SWZ. d) Subject-matter evidence referred to in Chapter VIII of the SWZ, point 1, subitems 1)–3). e) Subject-matter evidence referred to in Chapter VIII of the SWZ, point 1, subitem 4). f) Power of attorney (if applicable). NOTE!!! The documents listed in point XII.1 a), b) constitute the content of the tender and therefore may not be supplemented. The absence of these documents renders the submitted tender invalid. The Contracting Authority informs that the documents referred to in Chapter VIII.1, subitem 4) of the SWZ may not be supplemented. If these documents are absent, the Contractor will receive 0 points under tender evaluation criterion K2. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.