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MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies

Regulatory Affairs Medical Devices In Vitro Diagnostics
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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

On June 17th, 2024, the Medical Device Coordination Group (MDCG) released a new revision of the guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting a) assessments of conformity assessment bodies (CABs) that apply for designation of notified bodies (NB) in the field of medical devices and/ or in vitro diagnostic medical devices and b) re-assessment of NBs (MDCG 2022-13 Revision 1).

MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies
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MDCG 2022-13 Revision 1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies

This guidance 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 and now includes updates on the conduct of joint assessments relating to extending the scope of designations.

 

 

CTA RA update


 

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