| Theme | Re-assessment of notified bodies |
| Target Audience | Designating authority, NB |
| Products concerned | IVD |
| Documents mentioned | IVDR (EU) 2017/746 article 40(10) MDCG 2022-13 |
This document is a template form to be used by the designating authority in the context of the re-evaluation of notified bodies for the purpose of maintaining their designation under the IVDR (In Vitro Diagnostic Regulation).
This form 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.