a) The conformity of the device to the manufacturer’s QMS
b) The technical documentation and the EU DoC
c) PMS obligations in accordance with the IVDR
d) Reporting obligations in accordance with the IVDR
e) The statement referred to in Section 4.1 of Annex XIV is issued in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, if applicable.