Supply of disposable medical devices for laboratory diagnostics performed in the Central Clinical Laboratory of the National Institute of Geriatrics, Rheumatology and Rehabilitation in Warsaw, along with the lease of equipment for blood sedimentation measurement.

1. The detailed description of the subject of the order is contained in this SWZ and: 1) Annex No. 1 – offer form; 2) Annex No. 2 – assortment and price form 3) Annex No. 2A - list of required parameters, constituting the description of the subject of the order; 4) Annex No. 4 – draft agreement. 2. All requirements specified in the SWZ and the documents indicated above are minimum requirements, and their fulfillment is obligatory. Failure to meet the aforementioned minimum requirements will result in the rejection of the offer as non-compliant with the order conditions pursuant to Art. 226 sec. 1 point 5 of the Public Procurement Law. 3. The Contracting Authority requires the contractor to submit, along with the offer, the following subject-specific evidence to confirm that the offered supplies meet the requirements specified by the Contracting Authority in the SWZ (in particular in the description of the subject of the order): 1) a current document confirming the market access and use as a medical device meeting the requirements within the meaning of the Act of April 7, 2022 on Medical Devices (Journal of Laws 2024, item 1620) and compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / (EU) 2017/746 on in vitro diagnostic medical devices, bearing the CE mark - i.e.: declaration of conformity and/or certificate of conformity issued by the manufacturer or authorized/authorised representative confirming that the device meets the essential requirements); 2) information materials (brochure, catalog, data sheet, form, part of the user manual, statements and information or other materials from the manufacturer/distributor specifying the subject of the order and its parameters, etc.), confirming the requirements contained in Annex No. 3 (with the required parameters and items of the offered subject of the order highlighted) – excluding points 11-12 in Annex No. 2A to the SWZ, i.e. the list of required parameters - Description of the subject of the order (OPZ). 3) a statement from the Contractor confirming that the offered subject of the order meets the requirements specified by the Contracting Authority - according to the template constituting Annex No. 8 to the SWZ. 4. The Contracting Authority provides for the possibility of supplementing subject-specific evidence if the Contractor does not submit subject-specific evidence or if the submitted subject-specific evidence is incomplete. The Contractor may supplement subject-specific evidence, but only upon the Contracting Authority's request.