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Learn more about technical standards, why they are important and how to follow them.

This is required guidance

It is legally required and it is an essential activity.

This Guide covers:

  • Great Britain (England, Scotland, Wales)

From:

Developers - Post-market surveillance of medical devices - What's new

2023
Description Date
The MHRA has published new guidance on reporting adverse incidents involving Software as a Medical Device under the vigilance system. The content on our website has been updated to reflect the new guidance. July 14
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