For the purposes of this Regulation, the following definitions apply:

(22) ‘economic operator’ means the manufacturer, the authorised representative, the importer or the distributor;

Für die Zwecke dieser Verordnung gelten folgende Begriffsbestimmungen:

22. „Wirtschaftsakteur“ bezeichnet den Herstelle, Bevollmächtigten, Einführer oder Händler;

In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

In order to enable economic operators to demonstrate and the competent authorities to ensure that machinery or related products made available on the market are in conformity with the essential health and safety requirements, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, which include procedures from the least to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad hoc variants, conformity assessment procedures should be chosen from among those modules.

Manufacturers should draw up an EU declaration of conformity to provide information on the conformity of machinery or related products with this Regulation. Manufacturers may also be required by other Union legal acts to draw up an EU declaration of conformity. To ensure effective access to information for market surveillance purposes, a single EU declaration of conformity should be drawn up in respect of all Union legal acts. In order to reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to be a dossier made up of relevant individual declarations of conformity.