Poland – Orthopaedic supplies – Successive deliveries of materials for orthopaedic procedures – cemented unicompartmental knee joint endoprosthesis, including the establishment of a consignment stock and the loan of a power tool.

Opportunity description

The subject matter of the contract is the successive delivery of materials for orthopaedic procedures – a cemented unicompartmental knee joint endoprosthesis, including the establishment of a consignment stock and the loan of a power tool. A detailed description of the subject matter of the contract is contained in the Price Form – Annex No. 2 to the SWZ. Each Contractor may submit only one tender for the entire contract, in writing, otherwise it shall be null and void. If a Contractor submits more than one tender for the entire contract, all tenders submitted by that Contractor will be rejected by the Contracting Authority. The Contracting Authority stipulates that the offered subject matter of the contract must belong to the group of medical devices within the meaning of the Act of 7 April 2022 on medical devices (consolidated text: Journal of Laws of 2024, item 1620, as amended) and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC. The offered subject matter of the contract must have all necessary approvals for use in healthcare facilities in accordance with Polish law and European Union law. The subject matter of the contract offered by the Contractor must bear the CE marking and have valid documents permitting it to be placed on the market in the territory of the Republic of Poland and used in accordance with the provisions of the Act of 7 April 2022 on medical devices, including in particular a Certificate issued by a notified body and Declarations of Conformity. The Contractor is obliged to establish a consignment warehouse (Operating Theatre) within 3 working days from the date of conclusion of the contract. The first delivery must include delivery of the consignment stock in all sizes specified by the Contracting Authority. The consignment stock will be successively replenished after each procedure with the set used or its individual components. The Contractor shall lend the Contracting Authority, for the term of the contract, the necessary instrumentation: a power tool with a reciprocating saw. The instrumentation shall be provided no later than on the date of the first delivery of the subject matter of the contract. The Contractor is obliged to conduct/provide training in the use of the supplied equipment, including practical training at reference centres and/or training on unfixed anatomical specimens for the medical team. The Contractor is obliged to conduct/provide training in the use of the supplied equipment for the nursing team participating in surgical procedures. Procedure: open. Estimated value: 1,218,540 PLN. Review the original TED notice for the complete requirement, lots, amendments and attachments.