ANNEX IVSupplementary provisions
ANNEX IV INTERNAL PRODUCTION CONTROL (Module A) 1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the PPE concerned satisfies the applicable requirements of this Regulation. 2. Technical documentation The manufacturer shall establish the technical documentation described in Annex III. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured PPE with the technical documentation referred to in point 2 and with the applicable requirements of this Regulation. 4. CE marking and EU declaration of conformity 4.1. The manufacturer shall affix the CE marking to each individual PPE that satisfies the applicable requirements of this Regulation. 4.2. The manufacturer shall draw up a written EU declaration of conformity for a PPE model and keep it, together with the technical documentation, at the disposal of the national authorities for 10 years after the PPE has been placed on the market. The EU declaration of conformity shall identify the PPE 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 manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.