Medical device CE marking

MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies – Revision 1


This document (revision 1) aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams 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, 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 revision 1 document can be downloaded in our library

Source: European Commission