MDCG 2022-13 Updated Guidance on Notified Bodies

The current guidance document regarding MDCG 2022-13 Rev. 1 Designation, Re-Assessment and Notification of Conformity Assessment Bodies and Notified Bodies has been updated to include new guidance concerning the extension of scope of designations during joint assessments. The initial release of this document was published in February 2018 as NBOG BPG 2017-1.

What Does the New Guidance Document Include?

This guidance document was created to provide those responsible for Notified Bodies (designated authorities) and joint assessment teams (JATs) guidance when conducting any of the following activities:

• • Assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices (IVDs).
  • Extensions of the scope of the designations of NBs.
  • Re-assessments of NBs.

Key Regulatory Requirements:

• • Requirements regarding the process for assessment, designation and notification for Medical Devices and IVDs can be found in (EU) MDR Regulation 2017/7453, Articles 38 – 42 and (EU) IVDR Regulation 2017/7464, Articles 34 – 38.
  • Requirements regarding the process for reassessment concerning Medical Devices and IVDs can be found in (EU) MDR Regulation 2017/7453, Article 44(10) and (EU) IVDR Regulation 2017/7464, Article 40(10).
  • Lastly, requirements regarding the process for extending scope of designation concerning Medical Devices and IVDs can be found in (EU) MDR Regulation 2017/7453, Article 48 and (EU) IVDR Regulation 2017/7464, Article 42.

For more information you can read the full guidance document here.

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