Supply of medical devices for invasive neurosurgical procedures – Heading 1 – Neuroprotection equipment

… the individual tasks defined above, i.e. tasks 1 to 11. The Contracting Authority informs that the Contractor may submit a tender up to a maximum of 11 tasks. (without limiting the number of tasks per Contractor). A detailed description of the subject-matter of the contract is contained in Annex 2b to the ToR. · 3.3. Requirements of the Ordering Party regarding the subject of the contract: 1) the medical device offered must have approvals, certificates and be registered in accordance with the law requiring approvals, certificates and registration, 2) the medical device offered must be placed on the market and used in accordance with the requirements of the Act of 7 April 2022 on medical devices (Journal of Laws No. Journal of Laws 2024, item 1620, as amended), (3) the medical device offered must comply with the standards or technical specifications applicable to that device; If the medical device offered does not require notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Contractor is obliged to perform, at his own expense and on his own, all activities necessary to comply with all legal requirements related to the placing of the device on the market and use in the Republic of Poland. The Contractor is obliged to perform such activities within the deadlines resulting from the applicable regulations and provide the Ordering Party with relevant documents confirming the performance of such activities within these deadlines. 3.4. In cases where the description of the subject of the contract indicates trademarks, patents or origin, source or specific process that characterizes specific products or services provided by a specific contractor, this means that the Ordering Party cannot describe the subject of the contract in a sufficiently precise and intelligible way, but in any such situation the Ordering Party allows a solution equivalent to the one described above. In such situations, possible indications of trade marks, patents, origin, source or specific process that characterise specific products or services provided by a specific economic operator should be read together with the words ‘or equivalent’. Describing the subject-matter of the contract by reference to the standards, technical assessments, technical specifications and technical reference systems referred to in Article 101(1) CTMR; 1 point 2 and paras. 3, The Contracting Authority accepts solutions equivalent to those described In such situations, any indications should be read together with the words ‘or equivalent’. 3.5. The Ordering Party requires the execution of the subject of the contract on the terms set out in the contract. The draft provisions of the public procurement contract to be inserted into the contract are annexes to the tender specifications. 3. 7 Origin of goods. 1) The contractor undertakes that the goods delivered in performance of the contract will not originate in more than 50% of the total value of the order from the People’s Republic of China (PRC), if the order is subject to an IPI measure in accordance with Regulation (EU) 2025/1197 of 19 June 2025 (hereinafter: