MHRA Update Regarding Adverse Incidents Reporting

As of August 31, 2023, there are changes to how adverse incidents involving medical devices should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). This information is essential to ensure that your devices continue to meet appropriate regulatory requirements applicable in the UK market. (Full legal text: Medical Devices Guidance for Manufacturers on Vigilance). 

Key points for reporting adverse incidents involving medical devices to the MHRA

• • Vigilance Reporting Requirement: Adverse incidents involving medical devices occurring in the UK must be reported to the MHRA. This applies to the manufacturer, the UK Responsible Person, and the Authorized Representative based in Northern Ireland. 

• • Reporting Criteria: Adverse incidents meeting specific criteria, including death, serious deterioration in health, or potential contributory causes, must be reported to the MHRA. Even if an incident hasn’t resulted in such outcomes, it should still be reported if it has the potential to do so in the future. 

• • Medical Device Vigilance System: The process of reporting adverse incidents and field safety corrective actions (FSCA) involving medical devices is collectively known as the medical device vigilance system. 

• • Changes to Reporting System: Starting August 31, 2023, manufacturers must submit post-market vigilance reports to the MHRA using the MORE portal. You are required to register with the MHRA to use this portal for submissions.

• • XML Submission: Until August 31, 2023, the XML output of the Manufacturer Incident Report (MIR) form can still be sent to the AICxml@mhra.gov.uk mailbox.

• • Resources and Assistance: For detailed information on how to report incidents, including a step-by-step guide for using the MORE portal, you can refer to the guidance document available in the Resources section of your account on the MORE portal.