Division 5 Evaluation by the notified body prior to placing on the market

The manufacturer, or his authorised representative established in the Community, shall present a copy of his technical documentation to a notified body of his choice before the first item of equipment is placed on the market or put into service.

If there are doubts about the plausibility of the technical documentation, the notified body shall inform accordingly the manufacturer or his authorised representative established in the Community, and, if need be, carry out, or have carried out modifications to the technical documentation, or possibly, tests deemed necessary.

After the notified body has issued a report confirming that the technical documentation satisfies the provisions of this Directive, the manufacturer or his authorised representative established within the Community may affix the CE marking to the equipment and issue an EC declaration of conformity in accordance with Articles 11 and 8, for which he will bear complete responsibility.