[EU] MDCG 2024-12 - Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams

INTRODUCTION

 

This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereafter IVDR). It should be read in conjunction with the guidance document MDCG 2022-13 “Designation, re-assessment and notification of conformity assessment bodies and notified bodies”.

 

 

MDCG 2024-12 - Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams - European Commission (europa.eu)

MDCG 2024-12 - Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint asse

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