Examples of Reportable Incidents under the UK Medical Devices Vigilance System (2024 Amendment)

Overview of the 2024 Amendment

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 update the vigilance reporting requirements for medical devices placed on the market in Great Britain. These changes align with the broader post-market surveillance framework and clarify when and how manufacturers must report incidents to the MHRA. The guidance provides non-exhaustive examples of reportable incidents, focusing on serious incidents that may pose risks to patients, users, or others. Reporting is mandatory for manufacturers, authorised representatives (where applicable), and importers under certain conditions. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: examples of incidents to report under the vigilance system - GOV.UK

Definition of a Serious Incident

A serious incident is generally one that has led to, or could lead to, any of the following:

• Death of a patient, user, or other person
• Serious deterioration in the health of a patient, user, or other person
• Serious public health threat

Incidents are reportable even if the device performed as intended but contributed to harm, or if the root cause is uncertain but a serious outcome occurred or was possible.

Timeframes for Reporting

• Serious incidents resulting in death or unanticipated serious deterioration: report immediately (no later than 10 days after becoming aware).
• Serious incidents not resulting in death or unanticipated serious deterioration: report no later than 30 days after becoming aware.
• Trends or increases in frequency/severity of non-serious incidents that could become serious: report as field safety corrective actions or trend reports where applicable.

Manufacturers must submit reports via the MHRA’s online portal and follow up with additional information as requested.

Examples of Reportable Serious Incidents

The guidance lists numerous illustrative examples across device types and scenarios. Key categories and selected examples include:

Death or Serious Injury

• A defibrillator fails to deliver a shock during cardiac arrest, resulting in patient death.
• An insulin pump delivers an incorrect dose due to software malfunction, leading to severe hypoglycaemia and hospitalisation.
• A surgical implant (e.g., hip prosthesis) fractures, requiring revision surgery with complications causing permanent disability.

Serious Deterioration in Health

• A ventilator stops functioning without alarm, leading to hypoxia requiring intervention.
• A diagnostic device (e.g., blood glucose monitor) provides falsely low readings, causing inappropriate treatment and diabetic ketoacidosis.
• An infusion pump delivers overdose of medication due to occlusion alarm failure, resulting in organ damage.

Malfunction or Performance Issues

• A pacemaker battery depletes prematurely, requiring urgent replacement surgery.
• A stent delivery system fails to deploy correctly, necessitating emergency intervention.
• A diagnostic imaging device produces artefacts leading to misdiagnosis and delayed treatment.

Use Error or Labelling Issues Leading to Harm

• Incorrect instructions for use lead to wrong implantation of a device, causing infection or rejection.
• Mislabelling of a sterile device results in use of non-sterile product and subsequent sepsis.
• Ambiguous warnings fail to prevent overdose or misuse, leading to adverse outcomes.

Cybersecurity or Software-Related Events

• A connected medical device is compromised, leading to unauthorised modification of therapy settings and patient harm.
• Software bug in a radiotherapy planning system causes incorrect dose calculation, resulting in over- or under-dosing.

Other Reportable Scenarios

• Any incident where a device malfunctions or deteriorates during use, potentially leading to serious harm even if no harm occurred (e.g., near-miss events with high severity potential).
• Field safety corrective actions triggered by patterns of incidents.
• Incidents involving counterfeit or falsified devices causing harm.

Not all malfunctions are reportable; only those meeting the serious incident criteria require vigilance reporting. Manufacturers should assess each event against the criteria and document rationale for non-reporting. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: examples of incidents to report under the vigilance system - GOV.UK

Practical Advice for Manufacturers

• Establish robust internal processes for incident monitoring, investigation, and reporting.
• Train staff on the updated criteria and examples.
• Use the MHRA vigilance reporting portal and retain all supporting documentation.
• Consider trend analysis for proactive risk management and potential field safety notices.
• Consult the full guidance and MHRA for borderline cases or complex events.

These examples are illustrative and not exhaustive; professional judgement remains essential in determining reportability. The 2024 amendment strengthens post-market oversight to enhance patient safety across Great Britain.