| Theme | Assessment of notified bodies |
| Target Audience | Designating authority, NB |
| Products concerned | MD |
| Documents mentioned | MDR (EU) 2017/745 – article 39 MDCG 2022-13 |
This guidance document is a form template to be used by the designating authority as part of the assessment of notified bodies, with a view to their initial designation or the extension of their scope of designation.
This form enables 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.