Supply Interruptions & Discontinuations: The New Information Obligation for Medical Devices and IVDs

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MDRChats-by ChatMDR

ChatMDR

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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Supply Interruptions & Discontinuations: The New Information Obligation for Medical Devices and IVDs

MDRChats-by ChatMDR

9 minutes 50 seconds

1 year ago

Supply Interruptions & Discontinuations: The New Information Obligation for Medical Devices and IVDs

In the latest MDR Chats episode, we dive into the new guidance on Article 10a covering manufacturers' obligations for supply interruptions and discontinuations.

Highlights:

Essential timelines and reporting duties
Risk factors impacting patient safety
What qualifies as “exceptional circumstances”

Join Dr. Emily Bennett and host Oliver Harris to understand what these changes mean for medical device compliance in the EU.