Dentsply Implants NV

Article 15.3 (a), (b), (c), (d), (e) Primary PRRC Article 15.3 (a) - responsible for the conformity of the quality management system with regulatory requirements

Article 15.3 (a) - Deputy - responsible for the conformity of the quality management system with regulatory requirements

Article 15.3 (c) and (d) - responsible for compliance with Post-Market Surveillance obligations (in accordance with Article 10 (10)) and - responsible for fulfillment of reporting obligations (Articles 87 to 91)

Article 15.3 (c) and (d) - Deputy - responsible for compliance with Post-Market Surveillance obligations (in accordance with Article 10 (10)) and - responsible for fulfillment of reporting obligations (Articles 87 to 91)

Article 15.3 (b) and (e) - responsible for the approval and maintenance of the Declaration of Conformity - responsible for ensuring that the Technical Documentation is maintained and up to date - responsible for issuance of statement for investigational devices confirming that the device in question conforms to the general safety and performance requirements (Section 4.1 of Chapter II of Annex XV)

Article 15.3 (b) and (e) - Deputy - responsible for the approval and maintenance of the Declaration of Conformity - responsible for ensuring that the Technical Documentation is maintained and up to date - responsible for issuance of statement for investigational devices confirming that the device in question conforms to the general safety and performance requirements (Section 4.1 of Chapter II of Annex XV)