Medical devices, publication of the guideline on the assessment, re-evaluation and notification of Notified Bodies

The Medical Device Coordination Group, composed of representatives of the Member States of the European Union and chaired by the European Commission, approved the guideline MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies .

The guideline indicates the methods for carrying out the processes of assessment of conformity assessment bodies (CAB - Conformity assessment body) and of reassessment and notification of notified bodies (NB - Notified body) pursuant to Regulations (EU) 2017/745 and 2017/746.

The document addressed to the Authorities responsible for Notified Bodies (DA - Designation Authority) and to the Joint Assessment Teams (JAT - Joint Assessment Team) replaces the guideline BPG 2017-1 Designation re-assessment and notification of CABs and NBs.

SOURCE: www-salute-gov-it