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Art. 29
1 If the applicable conformity assessment procedure has demonstrated that the requirements of this Ordinance have been fulfilled, the manufacturer of devices that are not custom-made or investigational issues a declaration of conformity. The manufacturer shall continuously update this declaration. 2 The declaration of conformity shall include the information required in Annex IV to EU-MDR70, taking account of the amendments to this Annex adopted by the European Commission by means of delegated acts71. It must be written in one of the three official languages of Switzerland or English or translated into one of these languages. 3 If a device also requires a manufacturer's declaration of conformity for aspects not covered by this Ordinance but nevertheless required by other legislation in order to demonstrate compliance with that legislation, a single declaration of conformity shall be drawn up. 4 By drawing up the declaration of conformity, the manufacturer assumes responsibility for compliance with the requirements of this Ordinance and all other legislation applicable to the device. |