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Presumption of conformity of subsystems and safety components
Subsystems and safety components which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards or parts thereof.
Conformity assessment procedures
1. Before a subsystem or a safety component is placed on the market, the manufacturer shall submit the subsystem or the safety component to a conformity assessment procedure in accordance with paragraph 2. 2. The conformity of subsystems and safety components shall be assessed, at the choice of the manufacturer, by means of any of the following conformity assessment procedures: (a) EU-type examination (Module B — production type), set out in Annex III combined with one of the following: (i) conformity to type based on quality assurance of the production process (Module D), set out in Annex IV; (ii) conformity to type based on subsystem or safety component verification (Module F), set out in Annex V; (b) conformity based on unit verification (Module G), set out in Annex VI; (c) conformity based on full quality assurance plus design examination (Module H 1), set out in Annex VII. 3. Records and correspondence relating to the conformity assessment procedures shall be drawn up in an official language of the Member State where the notified body carrying out the procedures referred to in paragraph 2 is established or in a language accepted by that body.
EU declaration of conformity
1. The EU declaration of conformity for a subsystem or a safety component shall state that the fulfilment of the essential requirements set out in Annex II has been demonstrated. 2. The EU declaration of conformity shall have the model structure set out in Annex IX, shall contain the elements specified in the relevant modules set out in Annexes III to VII and shall be continuously updated. It shall accompany the subsystem or the safety component and shall be translated into the language or languages required by the Member State in which the subsystem or the safety component is placed or made available on the market. 3. Where a subsystem or a safety component is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned, including their publication references. 4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the subsystem or the safety component with the requirements laid down in this Regulation.
General principles of the CE marking
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Rules and conditions for affixing the CE marking
1. The CE marking shall be affixed visibly, legibly and indelibly to the subsystem or the safety component or to its data plate. Where that is not possible or not warranted on account of the nature of the subsystem or the safety component, it shall be affixed to the packaging and to the accompanying documents. 2. The CE marking shall be affixed before the subsystem or the safety component is placed on the market. 3. The CE marking shall be followed by the identification number of the notified body involved in the production control phase. The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his authorised representative. 4. The CE marking and the identification number referred to in paragraph 3 may be followed by any other mark indicating a special risk or use. 5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
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