(b) Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
(e) Ensuring that in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in § 4.1 of Annex XIV (EUIVDR) is issued
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BELLUATI Barbara
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(c) Ensuring that post-market surveillance obligations are complied with in accordance with Article 10(9);
(d) Ensuring that reporting obligations referred to in Articles 82 to 86 (EU-IVDR) are fulfilled