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Presumption of conformity of appliances and fittings
Appliances and fittings 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 I covered by those standards or parts thereof.
Conformity assessment procedures for appliances and fittings
1. Before an appliance or a fitting is placed on the market, the manufacturer shall submit it to a conformity assessment procedure in accordance with paragraph 2 or 3. 2. The conformity of series-manufactured appliances and fittings with the requirements of this Regulation shall be assessed by means of the EU type-examination (Module B — production type) set out in point 1 of Annex III, combined with one of the following modules, at the choice of the manufacturer: (a) conformity to type based on internal production control plus supervised product checks at random intervals (Module C2), set out in point 2 of Annex III; (b) conformity to type based on quality assurance of the production process (Module D), set out in point 3 of Annex III; (c) conformity to type based on product quality assurance (Module E), set out in point 4 of Annex III; (d) conformity to type based on product verification (Module F), set out in point 5 of Annex III. 3. In the case of an appliance or a fitting produced as a single unit or in small quantities, the manufacturer may choose one of the procedures set out in paragraph 2 of this Article or conformity based on unit verification (Module G) set out in point 6 of Annex III. 4. Records and correspondence relating to conformity assessment of an appliance or a fitting shall be drawn up in an official language of the Member State where the notified body carrying out the procedures referred to in paragraphs 2 and 3 is established or in a language accepted by that body.
EU declaration of conformity
1. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Annex I has been demonstrated. 2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annex III and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the appliance or the fitting is placed or made available on the market. 3. In order to assist compliance of finished appliances with the applicable essential requirements set out in Annex I, the EU declaration of conformity for a fitting shall state the characteristics of the fitting and shall contain instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance. The EU declaration of conformity shall be in a language which can be easily understood by appliance manufacturers and market surveillance authorities, as determined by the Member State concerned. 4. Where an appliance or a fitting 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. 5. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the appliance or the fitting with the requirements laid down in this Regulation. 6. A copy of the EU declaration of conformity shall be supplied with the fitting.
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 appliance and the fitting or to their data plate as far as relevant. Where that is not possible or not warranted on account of the nature of the appliance or the fitting, it shall be affixed to the packaging and to the documents accompanying the appliance or the fitting. 2. The CE marking shall be affixed before the appliance or the fitting 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 of the appliance or of the fitting and by the last two digits of the year in which the CE marking was affixed. 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.
Inscriptions
1. The inscriptions referred to in Annex IV shall be affixed visibly, legibly and indelibly to the appliance or to its data plate and, as far as relevant, to the fitting or to its data plate. 2. The inscriptions referred to in Annex IV shall be affixed before the appliance or the fitting is placed on the market.
Articles on this page are reproduced verbatim from official open data. See the attribution line.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.