Delivery of medical devices for invasive cardiac procedures Task 5 – cutting balloon catheter

Delivery of medical devices for invasive cardiac procedures Task 5 – cutting balloon catheter
3.3. The Ordering Partys requirements regarding the subject of the order: 1) the offered medical device must have approvals, certificates and be registered in accordance with legal provisions 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; If 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 its own expense and on its own, all activities necessary to fulfill all legal requirements related to placing the product on the market and for use in the Republic of Poland. The Contractor is obliged to perform such activities within the deadlines specified in applicable regulations and to provide the Ordering Party with appropriate documents confirming the performance of such activities within these deadlines. 3.4. In cases where the description of the subject of the order indicates trademarks, patents or the 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 order in a sufficiently precise and understandable way, however, in each such situation, the Ordering Party allows a solution equivalent to those described above. In such situations, any indication of trademarks, patents, origin, source or specific process that characterizes specific products or services provided by a specific contractor should be read together with the words or equivalent. When describing the subject matter of the contract by reference to the standards, technical assessments, technical specifications and technical reference systems referred to in Art. 101 section 1 point 2 and section 3, the Ordering Party allows 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 order on the terms specified in the contract. The draft provisions of the public procurement contract that will be introduced into the contract constitute annexes to the SWZ. Origin of the goods. 1) The contractor undertakes that the goods delivered under the contract will not originate in more than 50% of the total value of the order from the Peoples Republic of China (PRC), if the order is covered by the IZM measure in accordance with Regulation (EU) 2025/1197 of June 19, 2025 (hereinafter referred to as Regulation 2025/1197) and Art. 8 section 1 letter b Regulation (EU) 2022/1031 of the European Parliament and of the Council of 23 June 2022 on access of economic operators, goods and services from third countries to the EU public procurement and concession markets and procedures supporting negotiations regarding access of EU economic operators, goods and services to the public procurement and concession markets of third countries (International Procurement Instrument - IZM), hereinafter referred to as Regulation 2022/1031 2) The contractor undertakes not to subcontract more than 50% of the total value of the contract to entities from the PRC (Article 8(1)(a) of Regulation 2022/1031). INFORMATION ABOUT THE ANTICIPATED ORDERS REFERRED TO IN ART. 214 SEC. 1 POINT 7 AND 8, IF THE CONTRACTING AUTHORITIES TO AWARD SUCH ORDERS. The Ordering Party does not envisage awarding contracts referred to in Art. 214 section 1 point 7 of the Public Procurement Law. The Ordering Party does not envisage awarding contracts referred to in Art. 214 section 1 point 8 of the Public Procurement Law. DESCRIPTION OF THE CRITERIA WHICH THE ORDERING AUTHORITY WILL FOLLOW WHEN SELECTING AN OFFER, INCLUDING THE WEIGHT OF THESE CRITERIA AND THE METHOD OF EVALUATING OFFERS 13.1. The evaluation of offers will be carried out on the basis of the criteria specified in the SWZ and their weights. Offers will be assessed on points separately for individual Tasks. During the evaluation of offers, points are awarded for the following criteria according to the following rules: CRITERION PRICE weight: 60% In relation to tasks 1,2,4,5,6,7: CRITERION DATE OF COMPLETION OF THE ADDITIONAL PARTIAL CONTRACT weight: 40% In relation to tasks 3,8: CRITERION DATE OF COMPLETION PARTIAL ORDER weight: 40%