At least (IVDR Article 15):
(i) the conformity of the devices is appropriately checked, in accordance with QMS, before a device is released;
(j) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(k) the post-market surveillance obligations (Article 10(10));
(l) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(m) in the case of investigational devices, the statement referred to in Annex XV Chapter II Section 4.1 is issued.
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HANKS Sandra
At least (IVDR Article 15):
(i) the conformity of the devices is appropriately checked, in accordance with QMS, before a device is released;
(l) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(m) in the case of investigational devices, the statement referred to in Annex XV Chapter II Section 4.1 is issued.