Guidance

Vigilance reporting requirements

Updated 16 June 2025

Reporting under the GB Medical Devices Vigilance System (Regulations 44ZC, 44ZH, 44ZI, 44ZJ, 44ZK, 44ZN, 44ZO and 44ZP)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory authority for the UK medical device market. Once a medical device has been placed on the UK market, the manufacturer must submit reports to the MHRA when incidents that involve their device occur in the UK and meet the criteria detailed below. It is also good practice for manufacturers to notify their approved body (if they have one) of reportable incidents, dependent upon their contractual arrangements.

The manufacturer must also take appropriate action to address safety risks when required. This includes addressing risk relating to devices which they have already sold or made available for use. These actions are known as field safety corrective actions (FSCAs).聽

The notification and evaluation of serious incidents, trends and FSCAs involving medical devices is known as the GB medical device vigilance system.聽

The manufacturer is responsible for ensuring that all vigilance-related activities are conducted in accordance with the requirements. They may choose to delegate responsibility for individual tasks to a UKRP or an authorised representative (AR) based in Northern Ireland (NI). If so, there must be a documented agreement on responsibilities between all parties involved. The manufacturer still remains legally responsible for meeting these duties.

Where responsibility for the reporting of serious incidents, FSCAs and trends has been deputised to a third party, the manufacturer must ensure that all parties involved are familiar with this guidance document and are informed of all relevant post-market surveillance data concerning the devices. This will enable their UKRP or AR to fulfil their obligations.聽

The following guidance for medical device manufacturers covers what, how and when to report serious incidents, trends and FSCAs involving medical devices on the UK market. Manufacturers should read it in conjunction with new Part 4A of the UK MDR as inserted by .聽聽

Detail on the definition of incident, serious incident and public health threat is provided in the scope and definitions guidance.聽

a) Who must report to the MHRA

The manufacturer, UKRP or AR shall notify the MHRA about incidents and FSCAs which meet the reporting criteria; this includes periodic summary reports (PSR) and trend reports.聽

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 UKRP or AR) should submit a report to the MHRA.聽

b) What you must report to the MHRA (Regulation 44ZC)

Manufacturers must report serious incidents, FSCAs, and adverse trends. The reporting templates for each are available in the or in our guidance on the Manufacturers online reporting environment (MORE).

Regardless of how the manufacturer came to be aware of it, any incident considered to be serious must be reported to the MHRA. This includes incidents received from the MHRA as industry notifications of a public report (INPRs).聽聽

The regulations state:

바카라 사이트渟erious incident바카라 사이트� means an incident that directly or indirectly led, might have led or might lead to any of the following바카라 사이트�

• the death of any person;
• the serious deterioration of any person바카라 사이트檚 state of health;
• a serious public health threat;

For further information on the definition of incident, serious incident and serious public health threats please see our scope and definitions guidance.

Serious incidents (that is, those which must be reported) meet all three criteria:

1. An event has occurred, or an issue has been identified. This includes situations where testing performed on the device by the manufacturer, 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 manufacturer바카라 사이트檚 device is suspected to be a contributory cause of the event, including as a side effect.
3. The problem directly or indirectly resulted, or might have resulted, in death or a serious deterioration in state of health of a patient, user or other person.

The event becomes an incident when the second criteria apply and becomes serious and therefore reportable when the third criteria apply.聽

This includes serious public health threat where the above affects a large number of people and needs urgent action to address the risks.聽

Examples of indirect harm where the problem indirectly affected the patient or user include:聽

• misdiagnosis or delayed diagnosis
• transfusion of inappropriate materials
• delayed, inappropriate or absence of treatment.聽 The unavailability of a device to provide treatment, or the requirement to move a patient to an alternative device or therapy due to device failure could both result in serious injury
• transfusion of inappropriate materials

Not all serious incidents result in death or a serious deterioration in health. These may have been avoided because of the particular circumstances, or due to medical or surgical intervention, including self-administered treatment. Such treatment could be in the form of medication, first aid or other form of self-help. It is sufficient that if the incident were to occur again, it could have resulted in a serious deterioration in health if the patient, the healthcare professional or other individuals had not taken the same action. Manufacturers should report cases where a patient required revision of an implant to prevent a death or serious deterioration in health.聽聽

Incidents with the potential to result in serious harm should be reported even if they have not done so due to a pre-use check by the user. The presence of guidance on pre-use checks within the instructions for use does not alter this.

Therefore, manufacturers must still submit a report to the MHRA if:

• an incident associated with a device happened, and
• if it occurred again, it might lead to death or serious deterioration in health

If in doubt about whether to report an incident, report it.

The MHRA has provided examples of reportable incidents under vigilance.

Manufacturers should also check the list of device-specific vigilance guidance (DSVG) documents to see if any apply 바카라 사이트� see Medical devices: guidance for manufacturers on vigilance. These provide reporting advice on incidents relating to different types of medical device, including as individual serious incidents, as part of an agreed periodic summary report and if the manufacturer identifies an adverse trend.聽

In addition to fulfilling their vigilance reporting obligations as a manufacturer, assemblers of system or procedure packs should notify the manufacturer of any component in their pack of any serious incidents associated with their devices, of which they are aware. This is to enable the manufacturer of the component to fulfil their PMS obligations. As the MHRA develops the future medical devices regulatory regime, we will consider further consultation on including this notification requirement.聽聽聽聽聽

Use errors

The manufacturer must report incidents occurring because of use error if they conclude that they meet the definition of incident in 44ZC, and meet the criteria in section c, 바카라 사이트淲hat must be reported to the MHRA (44ZC)바카라 사이트�, regardless of whether the incident has resulted in a serious deterioration in health.

The definition of 바카라 사이트渋ncident바카라 사이트� in regulation 44ZC includes:

(c) an inadequacy in the design of the device, including an ergonomic feature, to enable the user to use the device safely and as intended by the manufacturer,

(d)聽an inadequacy in the information supplied with the device by the manufacturer to enable the user to use the device safely and as intended by the manufacturer.

Although a device may not have been used as intended, this may be a result of unclear instructions or an aspect of the design making correct use difficult.聽 The manufacturer바카라 사이트檚 investigation and subsequent report should include consideration of whether improvements in the device design including usability (ergonomic features), or clearer instructions/training could reduce the risk of reoccurrence of the use error and may be impacted by the number of use errors occurring. If it can바카라 사이트檛 be established within the reporting timescale whether or not the above applies, the manufacturer should submit an initial report.

Trend reporting requirements may also apply if a significant increase in the frequency or severity of these incidents is identified. Manufacturers should also consider whether FSCA could be undertaken to try to reduce this risk.聽 Guidance on usability and ergonomic features is available in these documents:

• MHRA guidance on applying human factors and usability engineering to medical devices. January 2021

The MHRA recommends that manufacturers also provide copies of their serious incident reports to their UKAB where they have one, at the time of reporting to MHRA. This can be included in the contractual obligations between the two parties.聽聽聽聽

What you must report to the MHRA: Important changes introduced with implementation of the PMS regulations

• definition for reportable side-effects
• clarification that interventions to prevent serious deterioration in health include self-administered treatment
• serious deterioration in health need not have occurred for a use error to be reportable, just the risk it could occur

c) Timescale to report a serious incident to the MHRA (Regulation 44ZH)

The manufacturer must notify the MHRA immediately upon becoming aware that one of its devices may have caused or contributed to an incident meeting the criteria of what must be reported to the MHRA.

The maximum permitted time between the manufacturer first becoming aware of the incident and notifying the MHRA are:

• 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
• if the situation which can result in the serious deterioration in state of health is not covered in the manufacturer바카라 사이트檚 existing risk analysis and evaluation documentation, it is considered to be unanticipated
• all other serious incidents: no later than 15 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 still submit a report within the relevant timeframe. Do not delay reporting because of incomplete information. Further details can be provided in a follow up report.

Timescale to report a serious incident to the MHRA: Important changes introduced with implementation of the PMS regulations

• 15 days to report all other serious incidents (was 30)

d) How to report to the MHRA

Manufacturers should submit reports to the MHRA relating to serious incidents, trends or FSCA for devices occurring in GB or NI via the . The MHRA will not accept any reports received via other routes.

A GB form is available in MORE for reporting serious incidents occurring in GB.聽 This should be used for all incidents, regardless of when the device involved was placed on the market/ put into service.

Manufacturers reporting serious incidents occurring in NI should continue to use the EU form within MORE.

See the 聽MORE guidance collection for guidance about how to use the portal.

e) What you should include in the initial incident report to the MHRA (Regulation 44ZH)

Initial incident reports must include all mandatory information. Required information is defined in the relevant schemas for MIR forms or through validations in the MORE web forms. Manufacturers should complete reports with all relevant information known to them. Following submission of an initial incident report, the manufacturer must submit a final report on completion of their investigation, unless the report type is combined initial and final.

Full details of what must be included are set out in regulation 44ZH of the regulations. Clarification of certain aspects only is available below.聽

Details of the initial reporter

a) If the report has come from a healthcare professional, provide their name, profession, and professional contact details (including email address and telephone number). In the rare circumstances where this detail is not known, enter 바카라 사이트榥ot known바카라 사이트� in this field. Make all reasonable efforts to obtain this information during the investigation. Contact the medical devices safety officer (MDSO) for the trust in England and Wales, the Incident and alerts Safety Officer聽(IASO) for boards in Scotland and Medical Device Liaison Officer (MDLO) in Northern Ireland to obtain this information if required.

b) If the initial reporter is a member of the public, the manufacturer should verify with them whether they are content for their details to be shared with the MHRA. If not, the non-mandatory fields can be left blank.

c) If the source of the incident is a journal article, a registry, social media or similar, the manufacturer should provide details of this. Where the source is a journal article, provide a copy of the article where possible, or unique digital object identified (DOI) number if not. Where the source is social media, adhere to data protection rules when submitting a report.

UDI information

Devices may be labelled with a unique device identifier (UDI), which is a unique number used to identify specific devices. Manufacturers should use UDI derived from a standardised issuing authority where possible, for example GS1, HIBCC. See for further information. Use of this number ensures that a device can be correctly identified even if some of the other identifying information is missing, and facilitates traceability in the event of FSCA being required. Where the device has a UDI, this must be provided. If the device does not have a UDI, enter 바카라 사이트橴nknown바카라 사이트�.聽

Information on similar serious incidents relating to the same device model or model variant聽聽

The same model includes devices of available sizes, colours, naming variants or manufacturer sites associated with that model.聽聽

Manufacturers should provide this in the final incident report. If in a position to do so, the manufacturer should provide this in the initial report if they feel able to sufficiently characterise the incident to provide confirmation of the number of similar incidents they are aware of, involving this device or devices from the same model variant/family, they place on the market.聽 The absence of this detail should not delay submission of the initial report within the relevant deadline. These data can then be updated, if necessary, in the final incident report, following the manufacturer바카라 사이트檚 full investigation.聽

What you should include in the initial incident report to the MHRA: Important changes introduced with implementation of the PMS regulations

• inclusion of UDI (where available) in the incident report

f) Investigation of incidents (Regulations 44ZI, 44ZO and 44ZP)

The manufacturer has the responsibility for investigating incidents, regardless of how they came to be aware of them. They are also responsible for taking any corrective action which becomes necessary as a result of the investigation.聽

The manufacturer must provide any information requested by the MHRA relating to an ongoing investigation within 3 UK working days unless otherwise stated in correspondence (regulation 44ZI(3)(b)). The MHRA may apply discretion in granting a longer period if requesting information not expected to be readily available.

The responsible UKAB (if there is one) must provide the MHRA on request with information and assessments relevant to the incident(s) under investigation (regulation 44ZI(2)(c)).

There is no statutory timescale for provision of the final incident report to the MHRA, which should instead be provided as soon as possible. This is because the MHRA recognises that investigations will vary significantly in their complexity and therefore take different time to complete. Where the manufacturer is aware that completion of the investigation will take many months, they should keep the MHRA updated by submitting interim follow-up reports via the MORE portal.

The final report should include:

(i) the methods and conclusions of the investigation;

(ii) consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident.聽 If the manufacturer determines that FSCA is not required, a brief rationale should be provided.

(iii) details of any field safety corrective action the manufacturer has taken or intends to take.聽 Where FSCA is planned, a copy of the CAPA report and health hazard evaluation should be provided.聽 Where FSCA has already been undertaken, the manufacturer should provide the MHRA reference number and manufacturer reference number for the FSCA.

(iv) details of similar serious incidents involving the same device model or a variant of that model.聽 The manufacturer should provide a rationale for how the incidents were classified as similar.

Incident investigation may require device examination and destructive testing on the device involved. Manufacturers must inform the MHRA before performing any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident (regulation 44ZI(3)(c)).聽 Manufacturers should include this information within the 바카라 사이트楳anufacturer바카라 사이트檚 preliminary analysis바카라 사이트� section in the MIR form.

Manufacturers should identify which of the following apply before taking action:

• if the incident resulted in a death, the manufacturer should try to determine whether there is coroner or police interest before undertaking any action which may alter the evidence available
• if there is coroner interest or police involvement for any incident regardless of outcome, the manufacturer should seek advice from the MHRA and the coroner/police before beginning any destructive testing and should not proceed before approval is provided by the coroner/police
• in all other cases the manufacturer should assume it is appropriate to progress with any required investigation without delay unless specifically asked not to do so by the MHRA or any other interested party

Reports received by the MHRA

There will be some incidents which are reported to the MHRA before or instead of being reported to the manufacturer, or circumstances where the MHRA has identified a risk or safety concern.聽

If the MHRA informs the manufacturer of an incident, risk, or safety concern they must investigate and submit a report to the MHRA:聽

• within the standard timescales for the incident type (regulation 44ZO)), or
• as soon as possible for any other risks or safety concerns (regulation 44ZP(2))

If the manufacturer does not consider the incident to be reportable, they can either submit an initial report followed by a final (non-reportable) report or submit a final (non-reportable) report (even if there is no initial report) (regulation 44ZO(3)).聽

The final (non-reportable) report should include detail concerning the root cause and the rationale as to why the incident does not meet the criteria for reporting. It should be submitted via the , with the MHRA reference number from the user report entered into the NCA reference number field. This number will be in the format YYYY/MM/DD/XXX/XXX.

The MHRA will not accept any reports received via any other routes including email.聽

If the MHRA reaches a conclusion that an incident meets reporting criteria and informs the manufacturer of the decision, the manufacturer must report to the MHRA and investigate the case as a serious incident, regardless of whether their own assessment concurs (regulation 44ZO(4)).

Investigation of incidents: Important changes introduced with implementation of the PMS regulations

• provide the MHRA any information requested relating to an ongoing incident investigation or FSCA within 3 UK working days (unless otherwise stated in correspondence)
• detailed guidance on commencement of destructive device testing following notification to the MHRA of intention to do so
• detailed guidance on action in response to notification of an incident by the MHRA
• investigation and reporting in response to risk or safety concern the MHRA brings to the manufacturer바카라 사이트檚 attention

g) Periodic summary reports (Regulation 44ZH)

The manufacturer can submit a request to report via periodic summary reports (PSR) similar serious incidents with the same device or device type in a consolidated way, where the root cause is known or following an FSCA. This is an alternative way for a manufacturer to fulfil incident reporting requirements by submitting single line entries in a spreadsheet for individual events, rather than individual initial and final MIR reports. This option includes the need to provide an overview analysis of the incident data, as set out below.聽

Manufacturers must submit an application to the MHRA if they wish to submit reports under PSR. Guidance for doing so can be found . If no agreement is in place, manufacturers must report incidents individually.聽聽聽

Before submitting any associated PSRs, the manufacturer must have received MHRA agreement, including confirmation of the format, periodicity, and detail to be included (see bullet points below).

All ongoing PSRs agreed before December 2022 have been stopped, and no submissions under the historic agreement will be accepted. Manufacturers wishing to continue reporting under PSR must submit a new application to do so and await MHRA response.聽聽

Once the MHRA has agreed to a PSR, each subsequent report must include:

• completed聽 PSR report form for the new submission
• completed spreadsheet of incidents being reported under the PSR - the template spreadsheet is available in the
  • you must use the template provided by the MHRA and not alter the format
  • the MHRA will not accept spreadsheets where alterations have been made to the template
  • mark any fields which are not applicable N/A
• an additional document detailing the manufacturer바카라 사이트檚 analysis of the data for the period
  • there is no specific format for this document, but manufacturers must demonstrate that the assessment undertaken is appropriate and illustrate how trends have been reviewed
  • the document should also include the conclusions reached based on the data available and outline action undertaken in response
  • specific requirements for information to be included in PSR submissions will be included in the approval email from MHRA on a case-by-case basis

h) Trend reports (Regulation 44ZN)

Manufacturers must have systems in place to detect trends throughout the PMS period of the device (regulation 44ZN(4)).聽聽

They must submit a trend report to the MHRA when they have identified a significant increase in the number or severity of incidents, compared to pre-determined thresholds based upon expected incidents, where the manufacturer considers that the increase could have a significant adverse impact on the outcome of the required risk-benefit analysis and assessment. Guidance on methods to establish whether an increase is statistically significant is available in and in . However, manufacturers should select the statistical techniques which best suits the data they are analysing, and be prepared to provide justification for the method chosen if required to the MHRA and/or the UKAB.

Guidance for submitting trend reports via MORE is available in the (page 20). A Trend report form is available within MORE.聽 Each initial trend report must lead to a final report.

Manufacturers should submit trend reports for trends in incidents regardless of whether these incidents meet the criteria to be reported individually.聽 This means that incidents which meet the individual reporting criteria (serious incidents) as well as those which do not should be reported as part of a trend.

Trend reports may include information derived from analysis of incidents which have already been individually reported to the MHRA. If an incident meets the criteria for individual reporting and is also part of a trend, it must be individually reported and reported again as part of the trend report. The following information, which is part of what is required in the trend report, should be included once the trend form/schema has been updated to add the relevant fields (regulation 44ZN(5):

• UDI information for the devices involved (where available)
• the number of devices placed on the market or put into service in Great Britain (provide UK-wide data if GB data is not available)
• the estimated number of users affected

Note: trend reports to the MHRA are not required for custom-made devices, although the requirement to identify adverse trends still applies. However, the manufacturer must have appropriate systems, tailored for the particular type of device, to enable any adverse trends to be detected.

Examples of reportable trends include:

• a significant increase in number of expected false positive or false negative results from a diagnostic test in comparison to the stated performance of the device in the instructions for use
• a number of complaints are received involving devices supplied cracked and unusable due to damage caused in transit
• a higher-than-expected number of complaints are received concerning over-infusion from an infusion pump with the same root cause
• a significant number of complaints are received concerning failure of an implant, despite these occurring beyond the manufacturer바카라 사이트檚 specified lifetime of the device
• a significant increase in the rate of strokes among patients implanted with a particular kind of carotid stent

Trend reports: Important changes introduced with implementation of the PMS regulations

• manufacturers should submit trend reports for incidents which are reportable individually, as well as those which do not meet the criteria for individual reporting
• detailed requirements for information to be included in a trend report, including UDI
• trend reports are not required for custom-made devices

i) Field safety corrective actions (Regulations 44ZJ and 44ZK)

(i) Field safety corrective actions (FSCAs)

Once a medical device is on the market, if the manufacturer identifies a problem which could result in death or serious deterioration in state of health in patients, users or others, they must take action to reduce the risk. If this affects devices which have entered the distribution chain outside the control of the legal manufacturer, this is known as field safety corrective action (FSCA).

Examples of FSCA include (but are not limited to):

• the return of a medical device to the supplier (recall)
• device inspection
• device modification or software update
• calibration updates for IVDs
• updated guidance in instructions for use, or drawing attention to existing guidance
• giving advice about the follow-up of patients, users, or others

Manufacturers should undertake a detailed analysis and evaluation of the identified risk and the actions proposed to address the issue. This is also known as a health hazard evaluation.

Manufacturers should notify the MHRA of FSCAs using the FSCA report form (FSCARF) which they must submit via the . Use this reporting process for FSCAs which affect devices in GB or in NI. A single submission can be made for FSCAs which affect both countries.聽

If you are reporting an FSCA as a UKRP, you must provide details by selecting 바카라 사이트極ther, identify the role바카라 사이트� in Section 2 of the FSCA form, 바카라 사이트楽tatus of submitter바카라 사이트�. Enter 바카라 사이트楿KRP바카라 사이트� and add the UKRP details in the 바카라 사이트楴ational contact point information바카라 사이트� Section 5.

In the initial FSCA report form, manufacturers:

• should include manufacturer specific FSCA reference numbers (for example, including the manufacturer바카라 사이트檚 name in the title).
• must include UDI information where available
• must include the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected in Great Britain
• should include details of the communication strategy for ensuring the message contained within their FSN reaches as many affected users as possible.
• If the FSCA is related to a trend or incident which has already been reported to MHRA, the MHRA reference number should also be included.

Each initial FSCARF must lead to a final FSCARF. If the FSCA has been completed in the UK but is ongoing in other territories, the manufacturer should submit a UK final report to the MHRA.

In the final FSCARF the manufacturer should provide evidence of the effectiveness of the FSCA. This should include, where possible, details of the number and proportion of affected GB/NI users receiving the FSN who have confirmed they have read and understood it. Further information should also be included on the extent of completion of all planned actions to mitigate the risk for which the FSCA was initiated.聽聽聽聽

The manufacturer must provide any information requested by MHRA relating to an ongoing FSCA within 3 UK working days unless otherwise stated in correspondence (regulation 44ZJ(8)).

The MHRA recommends that manufacturers also provide copies of their FSCARF and field safety notice to their UKAB where they have one, at the time or in advance of initiating FSCA. This can be included in the contractual obligations between the two parties.聽聽聽聽

(ii) Field safety notices (FSNs)聽

Manufacturers should communicate all FSCAs to affected customers using a Field Safety Notice (FSN), regardless of the type of medical device involved. If the MHRA become aware that a manufacturer has failed to implement FSCA appropriately, we will require a retrospective FSN to be produced and communicated to affected customers to detail the action carried out and why it was undertaken. The manufacturer will also need to provide a detailed and robust rationale for the decision not to undertake formal FSCA in line with the requirements. This is to ensure there is a clear and consistent record available to all explaining the action taken, and the reason for it.聽

The manufacturer should submit the proposed FSN with the initial FSCARF to MHRA before sharing with their customers so that we can provide advice on the FSCA implementation strategy or comments on the proposed FSN.聽聽

The initial FSCA report and proposed FSN must be submitted via MORE.聽 If the manufacturer is in contact with an MHRA benefit risk assessor, it is helpful to send them a copy for speed of review of the proposed FSN.

If you receive no response within 5 days of submitting the draft, you should circulate the FSN to your customers.

If the action required to protect patient safety is urgent, you can circulate the FSN to your customers without waiting the 5 days for a response from the MHRA.

The FSN must be sent in a format that enables customers to search for UDI information (wherever available), catalogue numbers, model numbers and LOT numbers. It is important that the manufacturer does not understate the risk within the FSN. The MHRA has published guidance on effective field safety notices.聽

We encourage manufacturers to use the following templates and guidance for writing FSNs:

The manufacturer must take reasonable steps to reach all end users affected by the FSCA.聽聽

They must monitor the effectiveness of the communication to ensure that users have taken the action required to reduce the risk

A read receipt, automated response or proof of delivery is not a suitable method to demonstrate that the required action has been taken. Wherever possible, use the FSN customer reply and distributor/importer reply templates, or adapt them for use if necessary.

When one form of communication has proved unsuccessful, the manufacturer should try an alternative method, for example, contact the customer by telephone or make an on-site visit).

The guidance on effective field safety notices draws attention to use of the Medical Device Safety Officers (MDSOs) in England and Wales, Incident and alerts Safety Officers聽(IASOs) in Scotland and Medical Device Liaison Officers (MDLOs) in Northern Ireland network to help with reconciliation. For healthcare establishments with large numbers of end users, consider including specific points of contact to ensure a coordinated approach.聽 The MDSO/IASO/MDLO contact details spreadsheet is updated on a regular basis.聽 If you do not receive a response from an MDSO, IASO or MDLO, please report this to MHRA.

Where devices are supplied via distributors and third-party organisations, the manufacturer must include traceability and information sharing in their contracts to ensure that they can fulfil this requirement.聽

It is good practice for manufacturers to host a copy of the FSN on their website (if they have one) and cooperate with any relevant distributors to enable them to do the same. This is not as a method to target the FSN to those affected, which should be managed proactively as detailed above. The purpose of publication in this way is to provide an accurate and transparent historical record for all interested parties of relevant actions, available along with other device information such as promotional material. The information in the FSN is already in the public domain and should be available where members of the public with an interest in the device would be expected to look. It should remain on the manufacturer바카라 사이트檚 website for the entire PMS period, or for 15 years for implantable devices/10 years for other devices, whichever is longer. As the MHRA develops the future medical devices framework, further consultation on inclusion of this requirement will be considered.

If the device subject to the action is a software app, the manufacturer should also communicate this via the app or in the app store.

(iii) Field safety corrective actions outside GB (Regulation 44ZK)

If the manufacturer is undertaking FSCA outside Great Britain (excluding NI) and the same type of devices are supplied in Great Britain but are not affected, they should notify the MHRA within 3 UK working days of the FSN being circulated. This is to provide transparency and avoid confusion by clarifying the reason that action does not affect the UK. This should decrease the burden on both the manufacturer and MHRA, where the MHRA would otherwise raise queries with the manufacturer on a case-by-case basis requesting justification why action affecting the same type of devices is not being implemented in the UK.

The MHRA considers devices which differ only by the name under which they are marketed in different geographical locations to be the same 바카라 사이트榯ype바카라 사이트�.

Circumstances where this applies includes a LOT specific FSCA where affected models were supplied in Great Britain, but devices from the affected LOTs were not, or where the risk arises due to local environmental conditions such as high/low temperatures.聽

Manufacturers should send an email to the aic@mhra.gov.uk mailbox with a copy of the FSN or the equivalent notice and an explanation which must include the following as set out in regulation 44KZ:

(a) the manufacturer바카라 사이트檚 name and contact details;

(b) the UK responsible person바카라 사이트檚 name and contact details (if there is one);

(c) descriptions of the devices, including any unique device identifiers;

(d) the number of devices placed on the market or put into service in Great Britain and the estimated number of users;

(e) a description of the FSCA and the reason why the FSCA is required outside Great Britain;

(f) the reason the same FSCA is not required in Great Britain.

Until further notice, do not submit these reports via the MORE portal unless they affect devices in NI.聽

This requirement (regulation 44ZK) does not apply to custom-made devices.聽

Field safety corrective actions: Important changes introduced with implementation of the PMS regulations

• requirement to submit the proposed FSN to the MHRA before sharing with customers, and detailed advice on subsequent timing of distribution to affected customers
• the FSN must contain UDI information where available and must be sent in a searchable format
• if the manufacturer is undertaking FSCA outside Great Britain and the same type of devices are supplied in Great Britain but are not affected, they must notify the MHRA
• provide the MHRA within 3 UK working days any information requested relating to an ongoing investigation or FSCA (unless otherwise stated in correspondence)