Any incident meeting the following three criteria must be reported to the MHRA as an adverse incident:

• An event has occurred – including situations where device testing, examination of device information, or scientific data indicates a factor that could cause or has caused an event.
• The manufacturer’s device is suspected to have contributed to the incident.
• The event resulted in, or could have resulted in:
  •  Death of a patient, user, or another person
  • Serious deterioration in the health of a patient, user, or another person

What Should Be Reported?

For SaMD, indirect harm is the most common outcome of adverse events. This harm may arise from medical decisions or actions taken (or not taken) by healthcare professionals, patients, or the general public based on outputs provided by the software.

Examples of indirect harm:

• Misdiagnosis
• Delayed diagnosis or treatment
• Incorrect clinical decisions

Potential causes of indirect harm:

• Imprecise or inaccurate results
• Inadequate quality controls
• Poor calibration
• False positive or false negative outputs

For self-testing devices, medical decisions may be made directly by the user, who is also the patient.

Examples of reportable adverse incidents:

• Performance or functionality issues
• Problems affecting diagnostic accuracy
• Decision-support software errors resulting in harm
• Issues related to connected hardware or software
• Human-device interface problems
• Use errors that lead to harm
• Inadequate labelling or instructions for use
• Cybersecurity or data integrity issues

How to Report?

MHRA must be notified of all adverse incidents occurring in the UK that involve medical devices. Comprehensive guidance is provided under Post-Market Surveillance and MEDDEV 2.12/1 rev. 8. All reports must be submitted through the MORE Portal, which requires user registration.

Reporting Types:

 1. Individual Event Reports

• Manufacturers must report adverse incidents individually.
• Customer feedback from UK app stores or social media should be monitored and reported when relevant.
• Every initial report must be followed by a final report, unless combined.
• Final reports must include root cause analysis, related incidents, and corrective or preventive actions.

2. Periodic Summary Reports (PSRs)

• Used for certain types of incidents, as agreed with the MHRA.
• Timing and content must be arranged in advance.

3. Trend Reports

• Required when there is a significant increase in incidents that would normally not be reported individually.
• Manufacturers must have systems to proactively identify and track incident trends.
• Reports must be submitted when a notable increase in incident rates is detected.

Who Must Report?

• The manufacturer
• The UK Responsible Person (UKRP)
• The Authorised Representative based in Northern Ireland

They are required to report incidents and FSCA-related information, including PSRs and trend reports. Manufacturers are responsible for performing investigations and implementing corrective measures. If an incident involves multiple devices from different manufacturers, each must submit a separate report.

Changes to the Incident Reporting System:

Reports must be submitted via the new MORE portal, which requires registration. XML MIR form submissions may continue via AICxml@mhra.gov.uk until April 2023.

When UK Responsible Persons submit reports, they must:

• Select “Other, please specify” in Section 1.3.1 of the MIR form
• Enter “UKRP” and complete Section 1.3.4 with full contact details

Further instructions can be found in the Resources section of the MORE portal.

Reporting Timescales:

• Serious public health threat: within 2 calendar days of awareness
• Death or serious deterioration in health: within 10 calendar days of awareness
• Other reportable incidents: within 30 calendar days of awareness

For PSRs and Trend Reports:

• PSR timelines must be pre-agreed with MHRA
• Trend reports must be submitted as soon as a significant increase in incidents is identified