PV Bulletin

MHRA Update on MRI Equipment Safety Guidelines

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its safety guidelines for magnetic resonance imaging (MRI) equipment.

Primary source: https://assets.publishing.service.gov.uk/media/6a7dca8b1f783fe89daaa258/MHRA_MRI_Guidance_v5-0-02.pdf

PV Impact Brief

Urgency: HighConfidence: high

What changed

Updated safety guidelines include corrections and new information from UKAS regarding accreditation for MRI imaging facilities, ensuring alignment with the latest safety standards and protocols.

Why it matters

Adhering to the updated guidelines is critical to ensure patient safety, compliance with health and safety legislation, and readiness for accreditation assessments in MRI services.

Action needed

Clinical safety teams are required to review and implement the updated guidelines, ensuring that workflows for MRI equipment safety are compliant with the latest standards, particularly focusing on UKAS accreditation.

Relevant for
Regulatory Intelligence LeadPV Quality LeadQPPV
Processes impacted
CAPA
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Guidance
Policy status
Updated
Publication date
2014-11-07
Last updated
2026-08-13
Policy change
The MHRA has issued an update to its clinical safety guidelines for MRI equipment, including specific corrections and incorporating new information from the United Kingdom Accreditation Service (UKAS) regarding accreditation for imaging facilities.

Key changes

Corrections to clinical safety protocols for MRI equipment; inclusion of updated UKAS accreditation requirements for imaging services; alignment with latest safety standards for MRI environments.

Affected workflows

CAPA

Responsible groups

Clinical SafetyQuality Assurance

PV impact

This update ensures that safety protocols for MRI equipment are aligned with the latest accreditation and safety standards. Clinical safety teams should review these guidelines to mitigate patient safety risks associated with MRI environments and ensure compliance with updated safety standards.

View regulator source

Source document details

Exact policy details

Publication Date
7 November 2014
Applies to: Initial publication of guidelines
Published on 7 November 2014. · p. 1 · High · Source
Last Updated
13 August 2026
Applies to: Last update of the safety guidelines
Last updated on 13 August 2026. · p. 1 · High · Source
Primary Legislation References
Health and Safety at Work etc Act 1974
Applies to: Guidance compliance with health and safety legislation
Includes responsibilities from the Health and Safety at Work etc Act 1974. · p. 5 · High · Source
UKAS Accreditation
BS 70000 accreditation for MRI services
Applies to: Quality assurance for MRI services
UKAS accreditation provides independent assessment framework for MRI services. · p. 8 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 13, 2026

Full briefing

Practical implication

Clinical safety teams are required to review and implement the updated guidelines, ensuring that workflows for MRI equipment safety are compliant with the latest standards, particularly focusing on UKAS accreditation.

The MHRA has issued updated safety guidelines for MRI equipment, incorporating new UKAS accreditation requirements and corrections to clinical safety protocols. Clinical safety teams must review these guidelines to ensure compliance with the latest safety standards and mitigate patient safety risks associated with MRI environments.

What changed: Updated safety guidelines include corrections and new information from UKAS regarding accreditation for MRI imaging facilities, ensuring alignment with the latest safety standards and protocols.

Why it matters: Adhering to the updated guidelines is critical to ensure patient safety, compliance with health and safety legislation, and readiness for accreditation assessments in MRI services.

Practical implication: Clinical safety teams are required to review and implement the updated guidelines, ensuring that workflows for MRI equipment safety are compliant with the latest standards, particularly focusing on UKAS accreditation.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Medicines and Healthcare products Regulatory Agency (MHRA)#policy-change#Guidance#firecrawl-policy-agent#Updated

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