- 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 (Article 15a)
- the post-market surveillance obligations are complied with in accordance with Article 10(10) (Article
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FRIEDMAN Bosmat
• The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. (Article 15b)
• The reporting obligations referred to in Articles 87 to 91 of EU MDR 2017/745 are fulfilled. (Article 15d)
• In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV of the EU MDR 2017/745 is issued. (Article 15e)