1. The conformity of the devices are in accordance with the QMS under which the devices are manufactured, before a device is released.
2. The technical documentation and the EU DoC are drawn up and kept up-to-date.
3. The EU MDR PMS obligations are complied with in accordance with Article 10(10).
4. The reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled in the case of
investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.