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Field Safety Notices (FSNs)

Regulatory basis

Field Safety Notice requirements derive from MHRA's adverse incident reporting guidance and the overarching FSCA obligations in Regulations 16–22 of the UK MDR 2002. MHRA requires FSNs to be submitted alongside FSCA notifications and publishes them on its website.

What is a Field Safety Notice?​

A Field Safety Notice (FSN) is the formal communication sent by a manufacturer to all affected parties — distributors, importers, healthcare facilities, and (where appropriate) patients or end users — when a Field Safety Corrective Action (FSCA) is initiated.

The FSN describes the safety issue, identifies the affected devices, and specifies the action required of recipients.

Mandatory elements of an FSN​

MHRA requires FSNs to contain the following information in a clear, plain-language format:

  • Title: "URGENT FIELD SAFETY NOTICE" (or "FIELD SAFETY NOTICE" for lower-urgency actions)
  • Date of issue
  • FSCA reference number
  • Manufacturer name and contact details
  • UKRP name and contact details (for non-UK manufacturers)

Device identification​

  • Device name and description
  • Affected models / catalogue numbers
  • Affected batch / lot numbers or serial number ranges
  • MHRA registration / UKCA certificate references

Problem description​

  • Clear description of the issue or defect
  • What the potential harm is
  • How frequently the issue has been observed (if known)
  • Whether any incidents have already occurred

Action required​

  • Precisely what the recipient must do
  • Deadlines for completing the required action
  • Instructions for returning, destroying, quarantining, or modifying affected devices
  • Confirmation form or acknowledgement request (recommended)

Contact information​

  • Who to contact with questions
  • How to report affected devices to the manufacturer
  • MHRA contact for escalation

Distribution of the FSN​

The FSN must be sent to:

  • All distributors who received the affected devices
  • All importers who received the affected devices
  • All healthcare facilities and users who received the affected devices (where identifiable)

For devices distributed to patients or end users, the FSN must be appropriate for that audience — lay language, clear instructions, and information about what to do next.

A copy of the FSN must be submitted to MHRA alongside or as part of the FSCA notification.

MHRA review and publication​

MHRA reviews FSNs submitted as part of FSCA notifications. MHRA may:

  • Accept the FSN and publish it on the MHRA website
  • Request modifications to the content or scope
  • Require the FSN to be reissued if it is unclear or incomplete

Published FSNs are available on the MHRA device alerts and safety notices page, providing transparency to healthcare professionals and patients.

Official references​

ReferenceDescription
UK MDR 2002, Regulations 16–22FSCA and FSN obligations
MHRA: Device alerts and safety noticesPublished FSNs — gov.uk
MHRA: Adverse incident reporting guidanceFSN content requirements
IMDRF/NCAR/N18FINALInternational FSN content standards