1. Internal production control

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on its sole responsibility that the product concerned satisfy the appropriate requirements of this Directive.

2. Technical documentation

The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the product to the relevant accessibility requirements referred to in Article 4 and, in case the manufacturer relied on Article 14, to demonstrate that relevant accessibility requirements would introduce a funda­ mental alteration or impose a disproportionate burden. The technical documentation shall specify only the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product.

The technical documentation shall, wherever applicable, contain at least the following elements:

(a) a general description of the product;