Poland - Medical Supplies

Description

The subject of the order is the supply of various medical devices including products for treatment of patients with EB. The detailed description and method of execution of the order is contained in the assortment and price table Annex 2 to the SWZ and the template contract Annex 4 to the SWZ. The Ordering Party declares that, being a data controller and having regard to the provisions of the Act of 10 May 2018 on the protection of personal data (hereinafter RODO), it has implemented security measures adequate to the risks identified by it and providing guarantees of proper protection of personal data provided within the proceedings. Detailed info clause Detailed information clause in Art. 13 RODO is included in the SWZ (Terms of Reference). The Contracting Authority does not require a deposit. The Contracting Authority does not foresee the possibility of awarding contracts referred to in art. 214 section 1 item 8. 1.
1) A certificate issued by a quality control entity confirming that the products supplied meet certain harmonised standards or technical specifications, in accordance with the Act of 20 May 2010 on medical devices (Journal of Laws of 2020, item 186, as amended), i.e.:a) a document confirming notification of the product to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, hereinafter referred to as the President of the Office, or a document confirming notification to the President of the Office of the introduction into the territory of the Republic of Poland of a product intended for use in that territory;b) a certificate of conformity in cases defined in the law on medical devices; c) a declaration of conformity, confirming that the medical device is compliant with the essential requirements; d) if the item described in the Terms of Reference is not classified as a medical device, the Contracting Authority requires a statement confirming the Contracting Authority's requirements.NOTE:- If a document confirming notification to the President of the Office is issued for a medical device, then the Economic Operator should submit only the document referred to in paragraph 1.1.a.- If the document referred to in paragraph 1.1(a) is not issued for a medical device, then the Contractor shall submit the document referred to in paragraph 1.1(b) of this section.- The Contractor shall submit only the document referred to in paragraph 1.1(a). 1(b) of this chapter.- If for a medical device, the document referred to in paragraph 1(1)(b) is not issued, then the Contractor shall submit the document referred to in paragraph 1(1)(c) of this chapter.- If for a medical device, the document referred to in paragraph 1(1)(c) is not issued, then the Contractor shall submit the document referred to in paragraph 1(1)(d) of this chapter. - as appropriate to the subject matter of the contract.22) Information materials containing description of the offered subject matter of the contract (prospectus, catalog, leaflet, technical data sheet issued by the manufacturer, etc.) confirming the requirements included in Enclosure No. 2 to the SWZ (indicating the required parameters, items of the offered subject matter of the contract);3) Contractor's statement that all the offered goods are admitted to marketing and use in the territory of Poland according to the binding regulations;2. If the Economic Operator fails to submit the above-mentioned evidence or if the submitted evidence is incomplete, the Contracting Authority will call for its submission or supplementation within the designated time limit.

Opportunity closing date

10 June 2022

Value of contract

to be confirmed