1 conformity of devices is checked in accordance with the QMS under which the devices are manufactured before a device is released
2 technical documentation and EU declaration of conformity are drawn up and kept up-to-date
3 post-market surveillance obligations are complied with in accordance with Article10(10)
4 reporting obligations referred to in Articles 87-91 are fulfilled
5 in the case of clinical investigation, the statement referred to in Section4.1 of ChapterII of Annex XV is issued