MDCG 2022-13 Rev.1 – Designation,…

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

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 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 re-assessment of NBs (MDCG 2022-13 Revision 1). 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.

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.

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Kirsten Van Garsse

MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services

With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.

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