The person responsible for regulatory compliance must ensure:
(a) Device conformity is checked according to the quality management system before release;
(b) Technical documentation and the EU declaration of conformity are maintained;
(c) Post-market surveillance obligations are met per Article 10(10);
(d) Reporting obligations in Articles 87-91 are fulfilled;
(e) For investigational devices, the statement in Annex XV, Chapter II, Section 4.1 is issued.