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(1) Ensure conformity of the device is appropriately checked according to the QMS before the device is released (2) Ensure PMS obligations are met (ref. Article 10 (10) of the EU MDR) (3) Ensure reporting obligations relating to vigilance are met (ref. Article 87 to 91 of the EU MDR)

(1) Ensure technical documentation and EU Declaration of Conformity (DoC) are drawn up and kept up to date; (2) Ensure that the Declaration for investigational device(s) used in clinical trials conforms to GSPR apart from aspects covered by the clinical investigation and every precaution has been taken to protect the health and safety of the subject (ref. Annex XV Chapter II Section 4.1 of the EU MDR)