Regulation (EU) 2016/426 of the European Parliament and of the CouncilShow full title

Article 7 Obligations of manufacturers

1. When placing their appliances or fittings on the market or when using the appliances for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I.

2. Manufacturers shall draw up the technical documentation referred to in Annex III (‘technical documentation’) and carry out the relevant conformity assessment procedure referred to in Article 14 or have it carried out.

Where compliance of an appliance or a fitting with the applicable requirements has been demonstrated by the procedure referred to in the first subparagraph, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the appliance or the fitting has been placed on the market.

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in appliance or fitting design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the appliance or the fitting is declared shall be adequately taken into account.

When deemed appropriate with regard to the risks presented by an appliance, manufacturers shall, to protect the health and safety of consumers and other users, carry out sample testing of appliances made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming appliances and fittings and recalls of such appliances and fittings, and shall keep distributors informed of any such monitoring.

5. Manufacturers shall ensure that their appliances and fittings bear a type, batch or serial number or other element allowing their identification, and the inscriptions provided for in Annex IV.

Where the size or nature of the appliance or the fitting does not allow it, manufacturers shall ensure that the required information is provided on the packaging or in a document accompanying the appliance or the fitting.

6. Manufacturers shall indicate on the appliance their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the appliance. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by consumers and other end-users and the market surveillance authorities.

Manufacturers shall indicate on the fitting their name, registered trade name or registered trade mark, and the postal address at which they can be contacted or, where that is not possible, on the packaging or in a document accompanying the fitting. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by appliance manufacturers and the market surveillance authorities.

7. Manufacturers shall ensure that the appliance is accompanied by instructions and safety information in accordance with point 1.5 of Annex I, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Such instructions and safety information, as well as any labelling, shall be clear, understandable and intelligible.

Manufacturers shall ensure that the fitting is accompanied by a copy of the EU declaration of conformity containing, inter alia, instructions for incorporation or assembly, adjustment, operation and maintenance in accordance with point 1.7 of Annex I, in a language which can be easily understood by appliance manufacturers, as determined by the Member State concerned.

However, where a large number of fittings are delivered to a single user, the batch or consignment concerned may be accompanied by a single copy of the EU declaration of conformity.

8. Manufacturers who consider or have reason to believe that an appliance or a fitting which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that appliance or fitting into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the appliance or the fitting presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the appliance or the fitting available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the appliance or the fitting with this Regulation, in a language which can be easily understood by that authority. That information and documentation may be provided in paper or electronic form. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by appliances or fittings which they have placed on the market.