Task 1 – Battery sternotom for the Operating Room of the Cardiac Surgery Department

3.3. Contracting Authority's requirements regarding the subject of the order: 1. the offered medical device must have approvals, certificates, and be registered in accordance with legal regulations requiring approvals, certificates, and registration, 2. the offered medical device must be placed on the market and used in accordance with the requirements of the Act of April 7, 2022, on Medical Devices (Journal of Laws of 2024, item 1620, as amended), 3. the offered medical device must comply with the standards or technical specifications applicable to this device; In cases where the offered medical device 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 their own cost and expense, all activities necessary to fulfill all legal requirements related to placing 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 applicable regulations and to provide the Contracting Authority with appropriate documents confirming the performance of such activities within these deadlines. 3.4. In cases where trademarks, patents, or origin, source, or a specific process characterizing specific products or services provided by a particular contractor are indicated in the description of the subject of the order, it means that the Contracting Authority cannot describe the subject of the order in a sufficiently precise and understandable way. However, in every such situation, the Contracting Authority permits an equivalent solution to those described in the manner above. In such situations, any indications of trademarks, patents, origin, source, or a specific process characterizing specific products or services provided by a particular contractor should be read together with the words "or equivalent". When describing the subject of the order by reference to standards, technical assessments, technical specifications, and technical reference systems referred to in Article 101(1)(2) and (3), the Contracting Authority permits solutions equivalent to those described. In such situations, any indications should be read together with the words "or equivalent". 3.5. The Contracting Authority requires the performance of the subject of the order under the conditions specified in the contract. The draft provisions of the public procurement contract, which will be introduced into the contract, constitute annexes to the SWZ. 3.7. Origin of goods. 1) The Contractor undertakes that the goods delivered within the scope of the contract execution will not originate from the People's Republic of China (PRC) in more than 50% of the total order value, if the order is covered by an IZM measure in accordance with Regulation (EU) 2025/1197 of June 19, 2025 (hereinafter referred to as Regulation 2025/1197) and Article 8(1)(b) of Regulation (EU) 2022/1031 of the European Parliament and of the Council of June 23, 2022, on the access of third-country contractors, goods and services to the Union's public procurement and concession markets and to procedures for awarding public contracts and concessions in support of negotiations on access of Union contractors, goods and services to third-country markets for public contracts and concessions (International Procurement Instrument – IPI), hereinafter referred to as Regulation 2022/1031. 2) The Contractor undertakes not to subcontract more than 50% of the total contract value to entities originating from the PRC (Article 8(1)(a) of Regulation 2022/1031). INFORMATION ON FORESEEN ORDERS REFERRED TO IN ARTICLE 214(1)(7) AND (8), IF THE CONTRACTING AUTHORITY FORESEES GRANTING SUCH ORDERS. The Contracting Authority does not foresee granting orders referred to in Article 214(1)(7) of the Public Procurement Law. The Contracting Authority does not foresee granting orders referred to in Article 214(1)(8) of the Public Procurement Law. 13. DESCRIPTION OF THE CRITERIA THE CONTRACTING AUTHORITY WILL USE TO SELECT THE OFFER, INCLUDING THE WEIGHTS OF THESE CRITERIA AND THE METHOD OF EVALUATING OFFERS. 13.1. The evaluation of offers will be carried out based on the criteria specified...