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.