Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies – June 2024

This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:

− assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices,
− extensions of the scope of the designations of NBs, and
− re-assessments of NBs.

Furthermore, this guide is intended to bring consistency and to align the working practices of the different designating authorities in the Member States, regarding the
assessment, designation, notification and re-assessment of CABs and NBs.

The processes for assessment, designation and notification are established by Articles 38 to 42 of Regulation (EU) 2017/745 (hereafter, the Medical Devices Regulation – MDR) and Articles 34 to 38 of Regulation (EU) 2017/7464 (hereafter, the in vitro Diagnostic Medical Devices Regulation – IVDR)…