[EU, MDR] Update - MDCG 2022-13 Rev.1 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies - June 2024

Introduction and scope

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 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).

 

 

Update - MDCG 2022-13 Rev.1 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies - June 2024 - European Commission (europa.eu)

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

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