Article 26, EU declaration of conformity, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.
2. Where EHR systems are subject to other Union legislation in respect of aspects not covered by this Regulation, which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the EHR system. The declaration shall contain all the information required for the identification of the Union legislation to which the declaration relates.
3. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into one or more official Union languages determined by the Member State(s) in which the EHR system is made available.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the conformity of the EHR system.