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MDCG 2019-13 Rev. 1: Understanding the Temporary Sampling Update episode artwork

Dec 17, 2024 7 min

MDCG 2019-13 Rev. 1: Understanding the Temporary Sampling Update

from MDRChats-by ChatMDR Hosted by ChatMDR

In this episode of MDR Chats, we explore the key update in MDCG 2019-13 Rev. 1: the temporary reduction of sampling requirements from 15% to 5% for MDR Class IIa/IIb and IVDR Class B/C devices. Learn what this means for manufacturers and notified bodies, and how to stay compliant while focusing on high-risk devices. 🎧 Listen now to stay informed! #MDR #IVDR #MedicalDevices #RegulatoryAffairs

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MDCG 2019-13 Rev. 1: Understanding the Temporary Sampling Update

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This episode is 7 minutes long.

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This episode was published on December 17, 2024.

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