Division 3

The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular:

• F1a general description of the product, including any variants planned and its intended use(s),

• design drawings, methods of manufacture envisaged and diagrams of components, sub-assemblies, circuits, etc.,

• the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operations of the product,

• the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards referred to in Article 5 have not been applied in full,

• in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,

• the results of the design calculations and of the inspections carried out, etc.; if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

• the solutions adopted as referred to in Annex I, Chapter I, Section 2,

• the pre-clinical evaluation,

• F2the clinical evaluation in accordance with Annex X,

• the label and instructions for use.