Theme | Designation of notified bodies |
Target Audience | Notified Bodies, Designating Authorities (authorities responsible for notified bodies), Joint Assessment Teams |
Products concerned | MD & IVD |
Documents mentioned |
Regulation (EU) 2017/745 Regulation (EU) 2017/746 Regulation (EU) 2017/2185 MDCG 2019-12 MDCG 2021-15 MDCG 2021-16 MDCG 2021-17 MDCG 2021-18 NBOG F 2017-5 NBOG F 2017-6 |
This guide, published in August 2022, is intended for use by Designating Authorities and Joint Assessment Teams to assist them when conducting assessments of Conformity Assessment Bodies applying for designation as NB or when reassessing NB.