2022-09

This guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 110(3) last subparagraph IVDR. To clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect of their quality management system.

The document applies to notified bodies that have lawfully issued certificates under the IVDD, regardless of whether or not those notified bodies have applied for designation or are designated under the IVDR (see MDCG 2019-10 rev.18) as long as the respective authority responsible for notified bodies has the right to and does monitor the notified body’s activities under Article 110(3) IVDR.

The document can be downloaded in our library

Source: European Commission