| Theme | Re-assessment of notified bodies |
| Target Audience | Designating authority, NB |
| Products concerned | MD |
| Documents mentioned | MDR (EU) 2017/745 article 46 MDCG 2022-13 |
This document provides a template form for use by designating Authorities (NAs) in the reassessment of Notified Bodies (NBs) for the purpose of maintaining their designation under the Medical Devices Regulation (MDR).
It allows the Designating Authorities to document the review of the Notified Body’s documentation.
It can be used as a living document during the various steps of the review.