Guidance

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Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

From:
Medicines and Healthcare products Regulatory Agency
Published
16 May 2025
Last updated
9 June 2025 — See all updates

Documents

GB MIR and FSCA schema implementation guide

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GB MIR and FSCA schema implementation guide

PDF, 497 KB, 21 pages

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Implementation of data requirements under the new Post-MarketingPost-Market Surveillance regulations

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Details

Following the passing of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, the MHRA has updated its processes and procedures to ensure that trends, patterns or signals that may reveal new risks or safety concerns are identified more efficiently. This will allow both the MHRA and the whole healthcare system to better protect patients.

For documentation to support these changes, see Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations

Updates to this page

Published 16 May 2025
Last updated 9 June 2025 href="#full-history">+ show all updates

  1. Link added for 'Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations'

  2. First published.

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