Division 4.2

F1The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).

It shall include inter alia:

• the design specifications, including the standards which have been applied,

• the necessary proof of their appropriations, in particular where the standards referred to in Article 5 have not been applied in full. This proof must include the results of the appropriate tests carried out by the manufacturer or carried out under his responsibility,

• a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of Annex 1, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted,

• the clinical evaluation referred to in Annex 7,

• the draft instruction leaflet.