This document aims to provide guidance to the authorities responsible for notified bodies (Designating Authorities) and joint assessment teams (JATs) when conducting:
i. Assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field MD and/or IVD.
ii. Re-assessments of NBs.
Furthermore, this guide is intended to bring consistency and to align the working practices of the different designating authorities in the Member States, regarding the assessment, designation, notification and re-assessments of CABs and NBs.
This guide focuses on the designation of CABs and subsequent re-assessment of NBs under the MDR and/or IVDR, including:
- 1. Designation assessments
1.1 Pre-assessment and off-site activities
1.2 On-site-assessment activities
1.3 Post on-site assessment activities
1.4 Decision on designation
2. Notification & publication in NANDO
Once the assessments procedure is completed, the designating authority will proceed with the notification of the designated CAB to the Commission and the other Member States. The notification must be done by using the Commission’s NANDO information system (New Approach Notified and Designated Organisations)
3. Re-assessment of notified bodies
The process for the conduct of re-assessments of NBs will generally follow the same procedure as for designation assessments of applicant CABs. Some specific differences will be described in section 4 of MDCG 2022-13.
4. Update of notification in NANDO
Once the re-assessment procedure is completed, the designating authority should proceed with the update of the notification in NANDO and will be required to enter the date for the next re-assessment.
Attachment: MDCG 2022-13 - Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies
MDCG 2022-13 - Designation, Re-assessment and Notification of Conformity Assessment Bodies and Notified Bodies