MHRA Guidance for Medical Device Manufacturers on Vigilance

Adverse incidents involving medical devices that occur in the UK need to be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). Once a medical device has been placed on the UK market, the manufacturer must provide vigilance reports to the MHRA when certain types of incidents that involve their device occur in the UK. Comprehensive information on the medical device vigilance system is given in MEDDEV 2.12/1 rev 8 and the additional guidance under ‘Post-Market Surveillance’, and outlines what, how, and when to report adverse incidents involving medical devices on the UK market.

1. Who must report to the MHRA
2. The requirement to report falls to:
3. the manufacturer
4. the UK Responsible Person
5. the Authorised Representative based in Northern Ireland

The manufacturer, UK Responsible Person or Authorised Representative shall notify the MHRA about incidents and FSCAs which meet the reporting criteria; this includes Periodic Summary Reports (PSR) and Trend Reports.

The manufacturer has the obligation for investigating incidents and for taking any corrective action necessary. The manufacturer is advised to also ensure that these guidelines are made known to their UK Responsible Person or Authorised Representative, who is advised to be kept informed of event reports. This will enable their UK Responsible Person or Authorised Representative to fulfil their obligations. Where an event occurs from the combined use of two or more separate devices (and/or accessories) that are made by different manufacturers, each manufacturer (or their UK Responsible Person or Authorised Representative) is advised to provide a report to the MHRA.

Changes to the event reporting system

manufacturers are required to report post-market vigilance reports to the MHRA via the MORE system or by sending an XML output of the Manufacturer event Report (MIR) form to AICxml@mhra.gov.uk.

Reports relating to adverse incidents for devices to the MHRA must be submitted via the new MORE portal or via custom Application Programming Interface (API) for direct submission from internal systems effective from 21 November 2022.

Current MORE account holders

From 21 November 2022, user will no longer be able to provide reports via the old MORE portal. User will have read only access and will be able to download existing reports until 30 April 2023. Any data in the old MORE account will not be migrated to new MORE account.

The AICxml mailbox

The AICxml@mhra.gov.uk mailbox will still be available for submissions until 30 April 2023 to allow user to transition the processes to the new submission routes.

In the new MORE portal, registered users will be able to continue to provide MORE forms via XML report upload, manual submission via the web forms within MORE portal or via Application Programming Interfaces (API). The MORE web forms that are available include:

1. Manufacturer event Report (MIR)
2. Field Safety Corrective Actions (FSCAs)
3. Trend Reports
4. Periodic Summary Reports (PSRs)
5. A new web form to enable submission of Serious Adverse Events (SAEs)

When a user registers on the new MORE portal, the user can have multiple user groups under one account in the system. The following user groups will be available for selection during the registration process:

1. Manufacturers,
2. Authorised Representatives (NI),
3. UKRP
4. Other importers, distributors, or submitters

If a user has an active account in the Device Registration system, user organization information will automatically populate in the web form if the user’s MORE registration is set up for the same organization

When and How to Report

If reporting as a UK Responsible Person, you must select ‘Other, please specify’ in Section 1.3.1. ‘Submitter of Report’ of the MIR form. Enter ‘UKRP’ and complete the contact details in Section 1.3.4. ‘Submitters details’. Each initial report must lead to a final report unless the initial and the final report are combined into one report. Note that not every event report will lead to a corrective action. If you are in doubt about whether to report an event, you is advised to report it. Do not delay reporting because of incomplete information. Further details can be provided in a follow up report.

Criteria for Incidents to be Reported

Any event which meets all three reporting criteria below is considered an adverse event and need to be reported to the MHRA:

1. An event has occurred. This includes situations where testing performed on the device, examination of the information supplied with the device, or any scientific information indicates some factor that could lead or has led, to an event
2. The manufacturer’s device is suspected to be a contributory cause of the event
3. The event resulted in, or might have resulted, in death or a serious deterioration in state of health of a patient, user, or other person

An adverse event may still be reported if:

1. An event is associated with a device happened, and
2. If it occurred again, it might lead to death or serious deterioration in health