Responsibilities according to MDR article 15:
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. (Article 15, 3b)
- the post-market surveillance obligations are complied with in accordance with Article 10(10). (Article 15, 3c)
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NAVEENAKUMAR Ramee
Responsibilities according to MDR article 15:
- 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. (MDR Article 15, 3a)
- the reporting obligations referred to in Articles 87 to 91 are fulfilled. (MDR Article 15, 3d)
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. (MDR Article 15, 3e)