This document1 aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting:

i. 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, and
ii. 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 States2, 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) 2017/7453 (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).
The processes for re-assessment are established by Article 44 (10) of the MDR and Article 40 (10) of the IVDR, whereby it is stated that three years after notification of a notified body, and again every fourth year thereafter5, a complete re-assessment to determine whether the notified body still satisfies the requirements set out in Annex VII to MDR and IVDR shall be conducted by the designating authorities and a joint assessment team.

In terms of scope, this guide focuses on the designation of CABs and subsequent reassessments of NBs under the MDR and/or the IVDR. A subsequent revision will address the processes for changes to designations and notifications (Article 46 MDR
and Article 42 IVDR).