PART 7 — Conformity assessment Module A — Internal production control

1.Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations set out in points 2, 3 and 4 of this Part, and ensures and declares on their sole responsibility that the products concerned satisfy the requirements set out in Parts 1, 5, 6, 16 or 17 which apply to them.

2.Technical documentation The manufacturer shall develop the technical documentation in accordance with Article 17 of this Regulation.

3.Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured product with the technical documentation referred to in point 2 of this Part and with the requirements set out in Parts 1, 5, 6, 16 or 17 which apply to them.

4.CE marking and EU declaration of conformity

(1)In accordance with Articles 15 and 16 of this Regulation, the manufacturer shall affix the CE marking and, when applicable, the UA class identification label, to each individual product that satisfies the applicable requirements set out in Parts 1, 5, 6, 16 or 17 which apply to them.

(2)The manufacturer shall draw up a written EU declaration of conformity for each product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The EU declaration of conformity shall clearly identify the product for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

5.Authorised representative The manufacturers’ obligations set out in point 4 may be fulfilled by an authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.