Art. 11 Declaration of conformity
1 The declaration of conformity shall be issued by the manufacturer or by its authorised representative according to the template in Annex 4. It confirms that compliance with the essential requirements has been demonstrated, and shall be continuously updated. 2 The declaration of conformity must be issued in an official Swiss language or in English or translated into one of those languages. 3 If the apparatus is subject to more than one set of regulations that requires a declaration of conformity, only one declaration need be issued. A dossier comprising several individual declarations is equivalent to a single declaration. |