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