This guidance document outlines the activities to be performed by notified bodies6 as part of the appropriate surveillance defined in Article 120 (3) second subparagraph MDR. In order to clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system.
The document applies to notified bodies that have lawfully issued certificates under the MDD or the AIMDD, regardless of whether or not those notified bodies have applied for designation or are designated under the MDR (see MDCG 2019-10 rev.17
) as long as the respective authority responsible for notified bodies has the right to and does monitor notified body’s activities under Article 120(3) MDR.
Article 110(3) of Regulation (EU) 2017/746 (IVDR) is outside the scope of this guidance document. However, principles outlined in the text and that are common between EU legislations for medical devices and in-vitro diagnostic medical devices may be applied also for activities to be performed by notified bodies according to Article 110(3) of the IVDR