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) 2017/7453 (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 extending the scope of the designation are established by Articles 46 of the MDR and Article 42 of the IVDR. These Articles prescribe that the procedures for designation mentioned above shall also apply to extensions to the scope of the designation.