MHRA

Guidance update: Medical devices post-market surveillance and vigilance

One week to go! The new Post-market Surveillance and Vigilance regulations for medical devices will come into force on 16 June 2025.

Before then, to help manufacturers, we have published:

The final data standards and guidance for Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) in Great Britain (GB), for the upcoming GB reporting requirements here.
A short presentation on the changing regulations providing further clarifications following stakeholder feedback here.

The new GB data schemas will be live within our Manufacturers Online Reporting Environment (MORE) from 16 June.

Further updates to guidance will also be released 16 June. Manufacturers should continue to use current guidance in the interim.

Please review the guidance here

Register for email updates to keep up to date with the latest changes: Medical devices: post-market surveillance - GOV.UK

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The Medicines and Healthcare products Regulatory Agency

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