Zad. 1 – Instrumentarium medyczne dla Bloku Operacyjnego Oddziału Neurochirurgii

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3.3. Contracting Authority’s requirements regarding the subject matter of the contract: 1) the offered medical device must have approvals (attestations), certificates and must be registered in accordance with the legal provisions requiring possession of approvals, certificates and registration, 2) the offered medical device must be introduced into circulation and use in accordance with the requirements of the Act of 7 April 2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620, as amended), 3) the offered medical device must comply with the standards or technical specifications applicable to this device; In the event that the offered medical device would not require notification to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, the Contractor shall be obliged, at its own cost and within its own scope, to carry out all activities necessary to satisfy all legal requirements related to the introduction of the device into circulation and use within the Republic of Poland. The Contractor is obliged to perform such activities within the time limits resulting from the applicable provisions and to provide…

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