Poland - Orthopaedic prostheses

Description

The subject of the contract is the supply of hip joint endoprostheses.Lot 1 Cementless hip endoprostheses with revision screws and snap-on optionLot 2 Cementless hip endoprostheses with revision socket and dual mobility optionLot 3 Cemented hip endoprosthesesLot 4 Primary cementless hip endoprostheses with cervical and capsular stemsLot 5 Primary cementless hip endoprostheses with capsular stemsLot 6 Cemented hip endoprostheses with capsular stems Part no. 5 Primary cementless hip replacement with epiphyseal stemPart no. 6 Hip replacement with stabilised acetabulum with serrated macro-structurePart no. 7 Revision stemsPart no. 8 Wagner dysplastic stemPart no. 9 Tantalum-based revision hip replacement
The subject matter of the contract has been described in detail in appendixes no 1 and 1a to SWZ (Terms of Reference).3 In appendix no 1 to SWZ (Terms of Reference) the Orderer requires the Contractor to provide the manufacturer, trade name and catalog code number of the subject matter offered by the Contractor. 4. The offered object of the contract must be allowed for marketing and use in the territory of the Republic of Poland in accordance with the requirements of the Act of 20 May 2010 on medical devices (Journal of Laws of 2021, item 1565, as amended) and European Union directives (in accordance with Article 26 of the Act of 20 May 2010 on medical devices (Journal of Laws of 2021, item 1565, as amended). It must have a Declaration of Conformity and CE Certificates - the Purchaser may, during the term of the contract, require the submission of these documents.5. The components of the endoprosthesis constituting a functional set must come from the same manufacturer.6. The supplied products must be sterile. Insofar as it is allowed in the description of the part, it is allowed to deliver medical devices in a non-sterile form. In such a case, the Contractor shall be obliged to provide appropriate containers serving as their packaging during sterilisation and storage.7. The unit packaging of the supplied devices must bear the trade name, catalog number, series and, for products supplied as sterile, the expiration date before which the product can be safely used.8.The expiration date of the supplied products must be at least 12 months from the date of delivery to the Purchaser.9. The products supplied during the performance of the contract must be identical to those offered in the tender.10. The Purchaser shall accept equivalent bids which meet the conditions for the subject matter of the contract. If the description of the subject matter of the contract includes own names, they should be treated only as examples of products, which exactly correspond to the description of the subject matter of the contract. In all such cases the Contracting Authority shall allow the submission of an equivalent offer, provided that the product proposed by the Contractor meets at least the requirements of the same class expected by the Contracting Authority, i.e. it meets the requirements described by the Contracting Authority. The product proposed as equivalent cannot differ in quality, standard or technical parameters from those required by the Contracting Authority. In the case of indicating trademarks or trade names, using the term "type", the Contracting Authority allows the submission of equivalent bids in the given assortment. Whenever a trademark, patent or origin is mentioned in the scope of item description, it is assumed that such indication is accompanied by the word "or equivalent". The Contracting Authority shall recognize as equivalent a product that has the same or better technical and quality parameters than those described, and its use in no way affects the proper functioning of the product in accordance with its intended purpose. The burden of proving equivalence is on the Contractor. The Ordering Party will not recognize equivalent solutions if they are worse than those indicated in appendix no. 1 to the SWZ (minimum quality, functional, technical and technological requirements).11. The conditions of realization of the subject matter of the contract have been included in the draft provisions of the contract constituting appendix no. 5a and 5b to the SWZ (Terms of Reference).

Opportunity closing date

03 June 2022

Value of contract

to be confirmed