The subject of the contract is: Successive delivery of consumable and disposable elements for the existing endoscopic set for minimally invasive spine surgery manufactured by Richard Wolf

2. A detailed description of the subject of the contract shall be included in the attachments:

No. 1 A to swz — Pricing form

No. 5 to swz -Table of parameters required.

VIII LIST OF THE EVIDENCE MEASURES IN QUESTION

1. In order to confirm the conformity of the supply offered, the Contracting Authority shall request the submission with the offer of the following measures of evidence:

1) Declaration of Conformity — a document issued by the manufacturer of the product or his authorised representative. (applies to all classes of medical devices)

2) Certificate of Conformity — a document issued by a notified body for medical devices certifying the conduct of conformity assessment procedures. (applies to medical devices classified in classes I sterile, I with measuring function, II A, IIb, III and in accordance with Union Directive 98/79 products of classes A and B)

3) Manufacturer's data sheets and/or other manufacturer's source materials (e.g. folders, brochures, technical data) confirming the required technical parameters for the offered accessories. The documents should contain, apart from the description of the parameters, the catalogue number, the full name of the product, drawings of the working part of the offered accessories, the Ordering Party accepts documents in English.

The documents listed above in point 1),)2,3) are submitted in order to confirm the compliance of the offered assortment with the description of the subject of the contract.

In a situation where the Contractor fails to offer the means of evidence in question or the evidence submitted in question are incomplete, the Contracting Authority shall call for them to be submitted or supplemented within the deadline set.

4) Manufacturer's data sheets and/or other source materials of the manufacturer (e.g. folders, brochures, technical data) confirming the evaluated limit parameters for the offered assortment - the Ordering Party allows documents in English.

The documents listed above in point 4) are submitted in order to confirm the compliance of the offered assortment with the description of parameters in the scope of the technical assessment criterion (Annex No. 1 A to the swz- Technical assessment table). Documents are an integral part of the offer, therefore they are not subject to supplementation, submission on request. In the absence of a document confirming the value of a given parameter, the Contractor will receive 0 points for this parameter.