• The conformity of the device(s) is appropriately checked, before a device is released,
• The technical documentation and EU declaration of conformity and drawn up and kept up to date,
• The post market-surveillance obligations are complied with in accordance with Article 10(10),
• The vigilance reporting obligations referred to in Articles 87 to 91 are fulfilled,
• In the case of investigational device(s), the statement referred to in section 4.1 of Chapter II of Annex XV is issued.