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Wednesday, December 7th

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MDCG 2022-17: MDCG position paper on hybrid audits

The Medical Devices Coordination Group (MDCG) sets out in document MDCG 2022-17 its position on the possible use of hybrid audits by Notified Bodies under Regulation (EU) 2017/745 (MDR) on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

This document aims to provide a definition for hybrid audits and clarifications with respect to how hybrid audits can be used under MDR and IVDR as advised following the publication of MDCG 2022-14.

DOWNLOAD THE POSITION PAPER MDCG 2022-17

MDCG 2022-17: MDCG position paper on hybrid audits

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