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

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MDRChats-by ChatMDR

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20 episodes

2 days ago

MDRChats is your go-to audio destination for simplifying the regulatory landscape for medical device professionals, supported by ChatMDR (https://chatmdr.eu/). Information on the latest updates, insights, and guidance documents; all designed to keep you informed and ahead in your field. Whether you're on your commute, taking a break, or just prefer listening over reading, MDRChats is designed to fit seamlessly into your day. Our episodes transform your available moments into productive insights on regulatory changes.

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

MDRChats-by ChatMDR

7 minutes 9 seconds

10 months ago

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

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.

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