Agreement Annex Eudamed

If the type complies with this Regulation, the notified body shall issue an EU-type examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the type-examination, the conditions of validity of the certificate and the data necessary for the identification of the approved type. The certificate shall be issued in accordance with Annex XII. The relevant parts of the dossier must be attached to the certificate and kept by the notified body with a copy. 2. Without prejudice to paragraph 1, information exchanged on a confidential basis between the competent authorities and between the competent authorities and the Commission may not be disclosed without the prior consent of the Authority. Each notified body shall be established in accordance with the national law of a Member State or the law of a third country with which the Union has concluded an agreement in this regard. Their legal personality and legal status are duly documented. Those documents shall contain information on the ownership and the legal or natural persons exercising control of the notified body.

The sponsor shall have an agreement to ensure that all serious adverse events or other events referred to in Article 80(2) are reported in a timely manner by the examiner(s) to the sponsor. If one of the Member States concerned does not agree with the conclusion referred to in the second subparagraph of this paragraph, it shall notify its refusal to the Commission, all the other Member States concerned and the sponsor, together with a detailed justification of the electronic system referred to in Article 73. If they do not agree with the notified national measure, they shall immediately inform the Commission and the other Member States of their objections through the electronic system referred to in Article 100. (55) `informed consent` means the free and voluntary expression of a subject`s willingness to participate in a particular clinical trial after being informed of all aspects of the clinical trial relevant to the review subject`s decision to participate or, in the case of minors and non-consenting subjects, an authorisation or agreement of its designated representative by law; include them in the clinical trial; – the activities and decisions of the notified body, including contractual agreements; The terms of a change of authorised representative shall be clearly defined in an agreement between the manufacturer, as far as possible, the outgoing authorised representative and the new authorised representative. . . .

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