Conformity of RBT’s medical devices to the Medical Device Regulation and Quality Management System.
Conformity of the Technical Documentation and EU Declaration of Conformity.
Compliance with Post Market Surveillance in accordance with Article 10 of the MDR
Compliance with the Vigilance reporting requirements of the MDR in accordance with Article 87 to 91.
In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.