Medical devices: guidance for manufacturers on vigilance
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Overview
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.
Who must report to the MHRA
The requirement to report falls to:
- the manufacturer
- the UK Responsible Person
- 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 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.
Incident reporting system
Manufacturers must report post-market vigilance reports to the MHRA via the MORE system or by sending an XML output of the Manufacturer Incident Report (MIR) form to aicxml@mhra.gov.uk .
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’.
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.
Criteria for incidents to be reported
Any event which meets all three reporting criteria below is considered an adverse incident and must be reported to the MHRA:
- 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
- the manufacturer’s device is suspected to be a contributory cause of the incident
- 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
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:
- an incident associated with a device happened, AND
- if it occurred again, it might lead to death or serious deterioration in health
Device Specific Vigilance Guidance (DSVG)
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 Cardiac Implantable Electronic Devices
DSVG Inferior vena cava filters
DSVG Joint replacement implants
Timescale for reporting an adverse incident to the MHRA
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:
- Serious public health threat: No later than 2 calendar days after the manufacturer becomes aware
- Death or unanticipated serious deterioration in state of health: No later than 10 calendar days after the manufacturer becomes aware
- Others: No later than 30 calendar days after the manufacturer became aware
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.
Timescale for reporting PSRs and Trend reports
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.
Field Safety Corrective Actions (FSCAs)
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:
- the return of a medical device to the supplier (recall)
- device inspection
- device modification
- device exchange
- device destruction
- retrofit by purchaser of manufacturer’s modification or design change
- manufacturer giving advice about the use of the device and/or the follow-up of patients, users or others
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:
- FSN template
- FSN template Q&A
- FSN customer reply
- FSN distributor / importer reply
- The MHRA’s published guidance on effective field safety notices
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.
Documents
- Effective field safety notices (FSNs): guidance for manufacturers of medical devices
- Reporting adverse incidents: biological and mechanical surgical heart valves
- Reporting adverse incidents: intraocular lenses
- Reporting adverse incidents: inferior vena cava filter (IVC)
- Reporting adverse incidents: joint replacement implants
- Reporting adverse incidents: neurostimulators
- Adverse incidents: in vitro diagnostic (IVD) blood glucose meters
Last updated 31 December 2020 + show all updates
-
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
-
First published.