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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is responsible for the UK medical device market.
Once a medical device has been placed on the UK market, the manufacturer must submit vigilance reports to the MHRA when certain types of incidents that involve their device occur in the UK. The manufacturer must also take appropriate safety action when required. The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use.
The notification and evaluation of adverse incidents and field safety corrective actions (FSCA) involving medical devices is known as the medical device vigilance system. 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 describes what, how and when to report adverse incidents involving medical devices on the UK market.
You should also check the device specific vigilance guidance below to see if any apply to your device.
The requirement to report falls to:
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 responsibility for investigating incidents and for taking any corrective action necessary.
The manufacturer should also ensure that these guidelines are made known to their UK Responsible Person or Authorised Representative, who should be kept informed of incident reports. This will enable their UK Responsible Person or Authorised Representative to fulfil their obligations.
Where an incident 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) should submit a report to the MHRA.
Manufacturers must report post-market vigilance reports to the MHRA. Reports relating to adverse incidents for devices to the MHRA can now be submitted via the new MORE portal. To use the new MORE portal you must register with us.
The XML output of the Manufacturer Incident Report (MIR) form can continue to be sent to the AICxml@mhra.gov.uk until April 2023.
If you are 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’. For more details on how to submit reports please refer to the guidance document in Resources tile on your account in the new MORE portal.
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 incident report will lead to a corrective action.
If you are in doubt about whether to report an incident, you should report it. Do not delay reporting because of incomplete information. Further details can be provided in a follow up report.
You must register with us for a new MORE account to be able to use the new MORE portal and/or API.
Register for a MORE account.
See the MORE registration guide for details on how to register.
The new MORE portal is available.
The legacy MORE portal is now read-only. You will no longer be able to submit any reports via this route. You will continue to have read-only access and will be able to download existing reports until 30 April 2023.
If you held an account on legacy MORE, we have not migrated any of your data to your new MORE account.
We recommend that you download any historical reports from your old MORE account as these will not be available in your account after 30 April 2023. Any draft reports in your old account will need to be re-created in your new MORE account for submission.
The AICxml@mhra.gov.uk mailbox will still be available for submissions until 30 April 2023 to allow you to transition your processes to the new submission routes.
We recommend you register to use the new routes of submission as soon as possible. After 30 April 2023, any reports received via this mailbox will not be accepted.
Reports submitted via the AICxml@mhra.gov.uk mailbox will not be visible on your new MORE account.
If you are interested in setting up an API to submit your reports directly from your internal IT systems to ours, please contact us for further information.
recording from the ‘Medical Devices webinar: Changing the way incidents are reported to the MHRA’ held in August.
More information about the upcoming changes to the system can be found in these slides
Watch the recording
Slides will be available soon.
Further instructions will be added to this page in due course, so please regularly return to this page for the latest information.
Please contact us at aic@mhra.gov.uk if you have any questions.
Any event which meets all three reporting criteria below is considered an adverse incident and must be reported to the MHRA:
Not all adverse incidents result in death or a serious deterioration in health. These may have been prevented because of other circumstances, or because of intervention. Therefore, you must still send us a report if:
The following documents provide further advice on reporting adverse incidents for different types of medical device. This includes reporting as individual events, as part of an agreed Periodic Summary Report or only if the manufacturer identifies an adverse trend (trend report).
DSVG Artificial heart valves
DSVG Blood glucose meters
DSVG Breast Implants
DSVG Cardiac ablation
DSVG Cardiac Implantable Electronic Devices
DSVG Coronary stents
DSVG Inferior vena cava filters
DSVG Insulin Infusion Pumps
DSVG Intraocular lenses
DSVG Joint replacement implants
DSVG Neurostimulators
The manufacturer should notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an event meeting the above criteria.
The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are given below:
If after becoming aware of a potentially reportable incident it is unclear whether the event meets the reporting criteria above, the manufacturer must submit a report within the relevant timeframe.
Timescales for reporting PSRs need to be agreed in advance with the MHRA. Trend reports should be submitted when you have identified a significant increase in the rate of incidents.
FSCAs are actions affecting devices already distributed and which are taken by a manufacturer in order to reduce the risk of death or serious deterioration in health. It is the reason for the field action, not the type of field action, which decides whether it is reportable as a FSCA.
Some examples of FSCAs. This is not a full list:
FSCAs should always be communicated to all affected customers using a Field Safety Notice (FSN).
We encourage manufacturers to use the following templates and guidance for writing FSNs:
Manufacturers should notify the MHRA of FSCAs using the FSCA Report Form and are encouraged to submit via the MORE system. Notification should be made before or when the FSCA action is implemented in the UK.
If you are reporting an FSCA as a UK Responsible Person, details must be provided by selecting ‘Other, identify the role’ in Section 2 of the FSCA form, ‘Status of submitter’. Enter ‘UKRP’ and add the UK Responsible Person details in the ‘National contact point information’ Section 5.
The MHRA encourages manufacturers to tells us of intended actions before carrying them out so that we can provide advice on the FSCA implementation strategy or comments on the draft FSN.
Updated changes to the Incident reporting system
Recording added for webinar ‘Changes to Submitting Adverse Incidents to Medical Devices to the MHRA’
Detailing changes to the Incident reporting system in the section ‘Changes to the Incident reporting system’
This page has been updated due to the end of the Brexit transition period.
New document for European Commission’s guidance on reporting incidents with cardiac implantable electronic devices
Added a new document – Effective field safety notices (FSNs): guidance for manufacturers of medical devices
New information about upcoming MDR and IVDR regulations added to the page.
Added a link to new guidance on medical devices regulation in a no deal scenario.
Further guidance on producing and distributing effective field safety notices has been added.
Link to European Commissions detailed guidance updated
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