i. The post-market surveillance report (PMSR)

The manufacturer must prepare aPMSR within 3 years of the first device being placed on the market or put into service (whichever is sooner), or if already on the market/put into service, within 3 years of this regulation coming into force. This is because the saving provision of the regulations (Amendment to Schedule 2A paragraph 6) mean that the requirements can come into force only from the date of commencement of the SI.  

The manufacturer should update the report when required but at least every 3 years. This provides flexibility for the manufacturer to align updates to thePMSR with similar requirements within other regulatory jurisdictions within this 3-year period or to spread the requirement across the year as needed.   

Providing the above requirements are met, the format and presentation of thePMSR may be determined by the manufacturer. The presentation and methodology used, however, should be consistent from one PMSR to the next, to enable comparison across reporting periods. The detailed guidance on preparation of a PSUR provides some useful suggestions on how to present information.

ii. The periodic safety update report (PSUR)

ThePSUR should not duplicate all data and reports generated by the PMS plan, but provide an overview of the PMS activities, data collection, analysis results and summary of conclusions.  

The manufacturer should prepare thePSUR according to a standardised format to enable a consistent method for reporting from one manufacturer to another for these higher-risk devices. Further advice is available on the format and presentation of data which should be followed as far as possible for all device classes. If a manufacturer decides that specific sections or datasets are not required, they should document the justification in the PSUR.  

As an overview thePSUR should include:   

·a summary of the results and conclusions of the benefit-risk determination based upon review of the risk analysis

·the supporting risk analysis

·the findings and conclusions of post-market clinical follow-up (PMCF)

·a description of any preventive or corrective action since device certification/declaration of conformity including FSCA and the rationale for doing so

·the volume of sales/supply in the UK

·an estimate of the size of the population using the device inside and outside the UK and the usage frequency, where practical

·the characteristics of the population using the device including details of any higher-risk sub-populations

To prepare the above summary, the manufacturer should consider the following elements:

·information concerning serious incidents, including those arising from side effects having a negative impact on the health of the patient, their care or on wider public health

·information from trend reporting

·information relating to non-serious incidents

·relevant specialist or technical literature, databases and/or registries

·information, including feedback and complaints, provided by users including patients and the public, distributors and importers

·publicly available information about similar medical devices inside or outside GB

Timescales for provision of PSURs by device risk classifications

SeePMSR and PSUR preparation and review requirements above

Class IIa

The manufacturer must produce the firstPSUR within 2 years of the device being placed on the market/put into service or if already on the market within 2 years of this regulation coming into force (see saving provision referenced above).   

Update thePSUR every 2 years throughout the PMS period.

Class IIb and Class III medical devices and Class C and D, and Annex II (list A and B) IVDs

The manufacturer must produce the firstPSUR within 1 year of the device being placed on the market/put into service or if already on the market within 1 year of this regulation coming into force (see Saving Provision referenced above).   

Update thePSUR every year throughout the PMS period.

Involvement of the approved body (UKAB)

SeePMSR and PSUR preparation and review requirements

The manufacturer must submit theirPSUR (and updated PSUR) to their UKAB if they have one, according to pre-agreed arrangements.  

For class C or D IVDs, for which there would be noUKAB, the EU requirements to submit the PSUR to the notified body should be followed. This aspect cannot be covered by this GB regulation.  

TheUKAB must take the PSUR into account as part of its assessment of the ongoing validity of certification they have issued for the device(s).  

ThePSUR should form part of the documentation which the UKAB reviews within surveillance activities relating to conformity assessment. This may include a sampling-based approach, depending on the device classification and assessment route chosen for the device.  

For class III, all implantable devices and Annex II list A and B IVDs, theUKAB must prepare a report on its conclusions from its review of the PSUR. The report should determine whether there is any impact on the validity of the device certification it has issued, and if so, provide details of any action that is needed. The time required to complete this report may vary depending upon the complexity of the PSUR, but it should be finalised as soon as reasonably practical. The MHRA has published further guidance on the UKAB report.  

Notified bodies should follow EU requirements for review of PSURs, as this aspect cannot be covered by this regulation.

Grouping of devices  

ForPSUR guidance, the term ‘device’ relates to a device model and not to an individual device, as individual devices are placed on the market at different moments during the period covered by the device certificate. A device should be associated with one basic UDI-DI when UDI is used (or one device for legacy devices) and may include different variants or sizes.

The manufacturer may prepare a single PSUR for a category/group of devices if they are covered by a single clinical evaluation or performance evaluation report and/or are considered similar devices. Where devices are grouped together, the manufacturer should justify the combination, and the data should be presented in a clear, organised manner so that it is easy to determine how each device and/or device variant performs independently.

The grouping of devices in onePSUR is only possible for devices for which the conformity assessment activities have been conducted by the same UKAB. This is to facilitate the review and evaluation process by the UKAB. UK CA-marked and CE-marked devices may be grouped together providing other grouping requirements are met, and they are within the remit of the same conformity assessment body.   

For devices, including the leading device, which have been on the market with subsequent certificates of different UKABs, the revision history provided should make a reference to the previousPSUR versions where the former UKAB(s) were involved and, when applicable, indicates the actions they required or undertook.   

The ‘leading’ device

For devices grouped together in the samePSUR, the manufacturer should assign a ‘leading device’ which needs to be the highest risk class or one of the highest risk classes. The PSUR reference number is attached to the leading device and should remain unchanged for the PSUR updates, provided the leading device in the grouped devices has remained the same.

The leading device determines the schedule for the data collection period andPSUR update/ frequency applicable to the whole group of devices irrespective of the device class or certification date for the other devices.  

When a device grouping has been established, it could be amended for the PSUR update(s) by removing or adding devices except for the leading device, which cannot be changed.  

The manufacturer should provide justification for the change, together with thePSUR reference number of the PSUR where the data of the removed device(s) are reported.  

In case of a change related to the leading device (new device model /change of the basicUDI DI), a new PSUR should then be issued.  

PSUR updates for the group of devices which includes the former leading device should continue independently for the PMS period of the former leading device.

Important changes introduced with implementation of SI:

·provision of PMSR or PSUR to MHRA on request within 3 UK working days  

·deadline for preparation of first PMSR and update at least every 3 years

·preparation of a PSUR to a standardised format, updated at set intervals

·submission of PSUR to approved body

·UKAB to review PSUR for any impact on device certification

·UKAB to prepare a report on review of PSUR for certain device classifications

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

a) Overview

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).

The notification and evaluation of adverse incidents and FSCAs involving medical devices is known as the medical device vigilance system.

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 aUKRP 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 incidents 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 theirUKRP or AR to fulfil their obligations.  

The following guidance for medical device manufacturers covers what, how and when to report adverse incidents involving medical devices on the UK market. Manufacturers should read it in conjunction with the relevant regulations of the SI.

b) 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.  

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 theirUKRP or AR) should submit a report to the MHRA.  

c) What you must report to the MHRA (44ZC)

Manufacturers must report serious incidents, FSCAs, and adverse trends. The reporting templates for each are available in the MORE portal.

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).

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, 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, 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.

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

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

·misdiagnosis or delayed diagnosis

·delayed, inappropriate or absence of treatment

·transfusion of inappropriate materials

Not all adverse 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.

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 – 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.  

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 theirPMS obligations. As the MHRA develops the future medical devices regime, we will consider further consultation on including this notification requirement.     

Use errors

The manufacturer must report incidents occurring because of use error if they conclude that they meet the criteria in section c, “What must be reported to the MHRA (44ZC)”, regardless of whether the incident has resulted in a serious deterioration in health. The 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. Trend reporting requirements may also apply if a significant increase is identified. Manufacturers should also consider whetherFSCA could be undertaken to try to reduce this risk.  

Guidance on usability and ergonomic features is available in these documents:

·EN 62366-1 2015 medical devices application of usability engineering to medical devices

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

Important changes introduced with implementation of SI:

·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

d) Timescale to report an adverse 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 event 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 manufacturer’s existing risk analysis documentation, it is considered to be unanticipated

·anticipated serious deterioration in state of health: 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.

Important changes introduced with implementation of SI:

·15 days to report anticipated serious deterioration in health (was 30)

e) How to report to the MHRA

Manufacturers should submit reports to the MHRA relating to adverse incidents for devices occurring in GB or NI via theMORE portal. The MHRA will not accept any reports received via other routes.

See theMORE Submissions Guide for guidance about how to use the portal.

To use theMORE portal, you must register for a MORE account. See the MORE registration guide for details on how to register.

If you are reporting as aUKRP, you must select ‘Other, please specify’ in Section 1.3.1. ‘Submitter of report’ of the MIR (manufacturer’s incident report) form. Enter ‘UKRP’ and complete the contact details in Section 1.3.4. ‘Submitters details’. For more details on how to submit reports, refer to the guidance document in the Resources tile on your account in the MORE portal.

Send reports using theMIR or FSCA schema.  

If you are interested in setting up anAPI (application programming interface) to submit your reports directly from your internal IT systems to ours, contact us for further information. See the MORE production API guidance document for more information about how to set up your API.

f) What should you 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 forMIR 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 SI. Clarification of certain aspects only is available below.

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 ‘not known’ in this field. Make all reasonable efforts to obtain this information during the investigation. Contact the medical devices safety officer (MDSO) for the trust or medical equipment management team for the health board 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 unique device identifier (UDI) 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 ’Unknown’.  

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

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

Manufacturers should provide this in the final incident report. 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. These data can then be updated, if necessary, in the final incident report, following the manufacturer’s full investigation.

Important changes introduced with implementation of SI:

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

g) 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.

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

The responsibleUKAB (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 theMORE portal.

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)).

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

·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

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.

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

·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 just submit a final (non-reportable) report (even if there is no initial report) (regulation 44ZO(3)).

If the MHRA reaches a conclusion that an incident meets reporting criteria, 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)).

Important changes introduced with implementation of SI:

·provide the MHRA any information requested relating to an ongoing incident investigation or FSCA within 3 UK working days

·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 manufacturer’s attention

h) 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.  

Manufacturers must submit an application to the MHRA if they wish to submit reports underPSR. Guidance for doing so can be found on page 21 of the user guide to MORE incident submissions. If no agreement is in place, manufacturers must report incidents individually.   

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 underPSR must submit a new application to do so and await MHRA response.   

Once the MHRA has agreed toPSR, each subsequent report must include:

· copy of the original completed PSR application form

· completed MORE PSR report for the new submission

· completed spreadsheet of incidents being reported under the PSR - the template spreadsheet is available in the MORE portal

·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 manufacturer’s 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

i) Trend reports (44ZN)

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

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, and therefore having the potential to adversely impact the required risk analysis.

Guidance on methods to establish whether an increase is statistically significant is available in PD CEN ISO/TR 20416 Medical devices — Post-market surveillance for manufacturers   and in this historical Global Harmonisation Task Force (GHTF) document. 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 viaMORE is available in the MORE incident submissions guide (page 20). Each initial trend report must lead to a final report.

Manufacturers should submit trend reports for trends in incidents which meet the reporting criteria (serious incidents) as well as incidents which do not meet the criteria for individual reporting. Trend reports may include information derived from analysis of incidents which have already been individually reported to the MHRA.

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 (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 manufacturer’s specified lifetime of the device  

·a significant increase in the rate of strokes among patients implanted with a particular kind of carotid stent

Important changes introduced with implementation of SI:

·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 (DN not yet visible in MORE)

·trend reports are not required for custom-made devices

j) Field safety corrective actions (Regulations 44ZJ and Regulation 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 ofFSCA 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 notify the MHRA of FSCAs using theFSCA report form (FSCARF) which they must submit via the MORE system. 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.  

If you are reporting anFSCA as a UKRP, you must provide details by selecting ‘Other, identify the role’ in Section 2 of the FSCA form, ‘Status of submitter’. Enter ‘UKRP’ and add the UKRP details in the ‘National contact point information’ Section 5.

In the initialFSCA report form, manufacturers:

·should include manufacturer specific FSCA reference numbers (for example, including the manufacturer’s name in the title).

·must include UDI information where available

·should include details of the communication strategy for ensuring the message contained within their FSN reaches as many affected users as possible.

Each initialFSCARF 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 finalFSCARF 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.     

The manufacturer must provide any information requested by MHRA relating to an ongoingFSCA within 3 UK working days (regulation 44ZJ(8)).

The MHRA recommends that manufacturers also provide copies of theirFSCARF 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.     

(ii) Field safety notices (FSNs)  

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.  

The manufacturer should submit the proposedFSN 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.   

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

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

TheFSN 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.  

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 manufacturer must take reasonable steps to reach all end users affected by theFSCA.   

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 Offices (MDSO) network to help with reconciliation. For heath institutions with large numbers of end users, consider including specific points of contact to ensure a coordinated approach.

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.

It is good practice for manufacturers to host a copy of theFSN 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 manufacturer’s 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 undertakingFSCA 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 in the FSCARF the reason that action does not affect the UK. This is to 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 ‘type’.

Manufacturers should send this submission to the aic@mhra.gov.uk mailbox with a copy of the FSN or the equivalent notice and an explanation. Until further notice, do not submit these reports via the MORE portal unless they affect devices in NI.  

Circumstances where this applies includes a LOT specificFSCA 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.  

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

Important changes introduced with implementation of SI:

·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

·the manufacturer should host a copy of the FSN on their website (unless they do not have a website)

·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

MHRA本周发布信息

Guidance

Medical devices: examples of reportable incidents

1. A urinary catheter was used even through the lubricious coating had dried. This may have been due to inadequacies in the labelling.

Rationale: there is potential for serious injury should the device be used with ineffective lubricious coating. The report should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use.

2. The administration set used with an infusion pump becomes occluded and no therapy is delivered. After some time, the infusion pump alarms to alert the user to the problem.  

Rationale: the alarm activated after the hazardous situation had already occurred.   

3. A patient with end stage renal failure passes away during haemodialysis treatment. The manufacturer is unable to determine whether there is any fault with the device or whether the death of the patient could be linked to the treatment.

Rationale: if, after becoming aware of a potentially reportable incident, it is unclear whether the event meets the reporting criteria, the manufacturer must still submit a report within the relevant timeframe. If it is later found to be non-reportable, this can be documented in the final report.

4. A continuous glucose monitoring device does not alert the user when their glucose level becomes dangerously high or dangerously low. The user feels unwell and self-administers insulin or glucose/sugar to avoid harm.

Rationale: as the device did not function correctly, serious deterioration in health was only avoided due to the action of the user.

Not all adverse incidents result in death or a serious deterioration in health(defined in Medical devices: post-market surveillance requirements). This may have been avoided because of the particular circumstances, or due to intervention by a user or patient, 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.  

5. The audible alarm on a ventilator fails to sound to alert the user to a technical fault. The user is alerted to the situation later once the patient’s condition has deteriorated, and a visual alarm alerts them to the situation.

Rationale: there is potential for serious injury should the device fail to alarm in a hazardous situation.

6. In silico analysis against emerging pathogen variants carried out by an in vitro diagnostic (IVD) manufacturer shows potential negative impact to the sensitivity of theIVD.  

Rationale: there is potential for false results from theIVD. The manufacturer should investigate this using suitable biological reference materials or clinical material to identify whether there is an impact on the IVD performance.

7. A self-testIVD has given a false negative, false positive or discrepant result. For example, an IVD for HIV produces a false negative result, meaning the user may then inadvertently spread HIV or may not receive appropriate treatment.  

Rationale: all false results should be reported to the MHRA, regardless of whether other IVDs, clinical tests or medical opinions would be used to make the final patient diagnosis. The manufacturer should carry out post market surveillance (including in silico testing, review of customer feedback and complaints, and validation of theIVD) to ensure the characteristics and performance of the IVD do not adversely affect the safety of the patient or user.

8. A softwareIVD has incorrectly read the diagnostic result from a SARS-CoV-2 lateral flow test, resulting in a false result which may impact the user’s behaviour and treatment.

Rationale: all false results should be reported to the MHRA, regardless of whether other IVDs, clinical tests or medical opinions would be used to make the final patient diagnosis.

9. A user misassembles a breathing circuit for a ventilated patient. As a result, pressure builds up in the circuit to an unexpected level.

Rationale: the event could result in serious deterioration of health. The report should include consideration of shortcomings related to the device design, difficulty in using the device safely, and whether there is a need to improve the information provided with the device to promote its proper and safe use.

Incidents occurring as a result of use error need to be reported if they meet the vigilance reportability criteria regardless of whether the incident has resulted in a serious deterioration in health. 

10. A sub-acute myocardial infarction (MI) occurred following implantation of a coronary stent, resulting in need for additional emergency clinical intervention.MI is one of the recognised potential adverse incidents listed in the associated instructions for use that is associated with use of this type of device.

Rationale: the event resulted in serious deterioration in health. The reportability status of an incident is not dependant on whether it is listed as a potential adverse event in the instructions for use.

11. A powered scooter tips whilst driving down a kerb, causing the user to fall. The height of the kerb was slightly more than the maximum safe kerb height quoted in the instructions for use.

Rationale: the event could result in serious deterioration of health as a result of the fall.

12. A person falls from a sling during transfer from a bed due to a faulty clip. There may have beeninadequacies in the pre-use check guidance.

Rationale: there is potential for serious injury as a result of a fall. The investigation should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use, as well as any design or manufacturing problems leading to the faulty clip.

13. A needle-free connector is used with a pre-filled syringe. The connector is not compatible, and it breaks, leading to a delay in delivering the medication. The inappropriate use may have been due to inadequacies in the instructions for use.

Rationale: there is potential for serious injury as a result of the delay in administration. The investigation should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use.

14. A critical care machine alarms following a disconnection. The alarm limits are accidentally altered due to unfamiliarity with the user interface and the user does not realise that the blood line has become disconnected, resulting in loss of blood.

Rationale: the event has the potential to result in serious deterioration in health.

15. The fluid in a bag of cell storage solution is a slightly different colour to the solution in other bags. The instructions for use state that the solution should not be used if contamination is evident but is not clear on how this should be identified.

Rationale: there is potential for serious injury as a result of the contamination. The investigation should include consideration of the type of contamination, the causes of the contamination, and the impact use of a contaminated device could have. It should also include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use.

16. A delayed use vascular graft is accidentally inserted instead of a rapid access graft. The packaging on both products is similar.

Rationale: because the wrong type of vascular graft was inserted, the patient would need to have additional surgical procedures which may not have otherwise been needed. The report should include consideration of whether there is a need to improve the information provided with the device to promote its proper and safe use.

17. A patient using an infusion pump at home turns the pump off and on again when it alarms for occlusion rather than clearing the cause of the occlusion or replacing the set as per the instructions for use. Therapy is not delivered as a result.

Rationale: there is potential for serious deterioration in health should the infusion not be delivered.

18. Remote monitoring of vital signs in mental health hospitals and care homes could lead to delay to diagnosis and treatment if it fails to detect the correct physiological parameters, for example, pulse rate, respiratory rate, and oxygen saturation.

Rationale: there is potential for serious deterioration in health as a result.

19. AI tools intended to identify or assist in identifying ‘normal’ x-rays miss an abnormality leading to an incorrect, delayed or missed diagnosis.

Rationale: there is potential for serious deterioration in health as a result of use of the erroneous result.

20. Compatibility issues arise from operating system updates for continuous glucose monitoring (CGM) apps resulting in loss of ability to see real time data leading to inappropriate or absence of treatment or a delay in diagnosis.

Rationale: there is potential for serious deterioration in health as a result.

21. A patient experiences a skin reaction or allergic reaction following use of a medical device.

Rationale: there is potential for serious injury and deterioration in health of a patient experiencing a serious reaction (for example,anaphylaxis). This includes adverse reactions where a possible irritant is labelled, as despite risk control options in place, a reportable event has still occurred.

22. A medical device is subject to unintended material degradation when used as intended.

Rationale: this could lead to exposure to hazardous chemicals and/or particulates resulting in potential harm. 

23. During an interventional procedure, the device does not perform as expected. This was not an out-of-box failure and the problem was not identified before using the device. The patient is not harmed at the end of procedure.

Rationale: there was a potential for procedural complication and serious harm to the patient. If, after becoming aware of a potentially reportable incident, it is unclear whether the event meets the reporting criteria, the manufacturer must still submit a report within the relevant timeframe. If the investigation later finds that the root cause of the performance issue is related to patient specific anatomy rather than a device defect, this can be documented in the final report.

24. An x-ray device fails to terminate an exposure resulting in unintended exposure of ionising radiation to the patient.

Rationale: there is potential for serious deterioration in health as a result of overexposure to ionising radiation.

25. Failure in a radiation treatment planning software device results in an incorrect radiotherapy treatment dose.

Rationale: there is potential for serious deterioration in health or patient harm due to incorrect therapeutic dose being delivered. Delivery of incorrect therapeutic dose to target area could result in under or overexposure of radiation to the patient. This could lead to a serious deterioration in health or patient harm (for example, disruption of treatment pathway, exposure to higher levels of radiation, ineffective dosing to target tumour or radiation burns).

26. Failure of PACS (picture archiving and communications system) to allow timely access to patients imaging data results in a delay to diagnosis.

Rationale: there is potential for serious injury as a result of the delay in diagnosis or treatment. Unexpected downtime or failure to rapidly access patient information can also lead to repeated imaging procedures and unnecessary radiation exposure.

27. A device is returned for examination by the manufacturer and a definitive root cause of the reported problem cannot be determined.

Rationale: the reportability status of an incident is not dependant on whether the root cause can be positively identified.

28. A reportable incident occurs but the device is not returned to the manufacturer for examination.

Rationale: the reportability status of an incident is not dependant on the availability of the device for investigation.

29. The manufacturer is aware of an increase in the frequency or severity of foreseeable or expected events.

Rationale: a changing pattern of foreseeable or expected events is reportable as a trend. Individual events in the trend report may or may not be reportable under vigilance.

FDA本周发布信息

Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA

This communication is part of theCommunications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Fresenius Kabi USA has issued a letter to affected health care providers recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue:

• Large Volume Pump (LVP) Software, version 5.9.2 and earlier

• Product code: LVP-SW-0005

• UDI:     00811505030122

• This software is part of the Ivenix Infusion System and is embedded in the Ivenix Large-Volume Pump, LVP-0004 (Pump UDI: 00811505030320)

What to Do

• On January 10, 2025, Fresenius Kabi USA began notifying affected customers recommending customers update the LVP software to version 5.10:

• Install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server to facilitate the installation of the pump software, LVP SW 5.10.

• To request installation of the software, LVP SW 5.10, contact your Fresenius Kabi      representative (1-855-354-6387 or Ivenix_support@fresenius-kabi.com) to      push the new software update to each of your pumps.

• When the software update is received by the LVP, the Update Software prompt shown below appears before the LVP is shut down.

• Select the      Update Software button to initiate the LVP version 5.10 software update.      Note that the LVP will not be available for use during a software update.

• Use care to not select the “Cancel” or “Shut Down Pump” buttons on the prompt as the software update will then not occur. The pump will prompt you every time you try to shut down the pump until the accept/install update is selected.

• If you are unsure of the software version on your pumps, both the “Systems      Dashboard” and “Pump Info” screen found under “More Options” allow you to      view the Version and date for your institution.

• If you are     unable to immediately install the software, then take the following actions until the infusion pump can be updated to software version 5.10:

• When frequent alarming occurs, restart the Ivenix LVP when clinical treatment allows.

• Prior to starting or restarting the secondary infusion, ensure the primary infusion has some volume remaining and has not reached zero.

• Check this web page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Fresenius Kabi USA reports the following anomalies associated with software versions 5.9.2 and earlier. These anomalies have the potential to cause serious patient harm or death.

If during an alarm condition the Pause Audio option is repeated 70 times or more, it will result in the pump becoming nonfunctional, which may lead to the patient being underdosed or delay their therapy. Underdosage may lead to patient harm including temporary arrhythmias, hyperglycemia, hypo- or hypertension, undersedation, and clotting changes.

If a secondary infusion is started at the exact moment a primary infusion completes, then the pump will switch to primary once the secondary infusion completes and Volume to be Infused (VTBI) reaches 0. Then, the primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty, which may lead to the patient being over infused. Over infusion may lead to patient harm including hyper- or hypoglycemia, hypo- or hypertension, electrolyte imbalance, oversedation, temporary arrhythmias, clotting changes, and unsuccessful resuscitation.

The firm has not reported any injuries or deaths associated with this issue.

Device Use

The Ivenix LVP software is the application embedded in the Ivenix Infusion System. The LVP software controls the functioning of the LVP and exchanges information with Infusion Management System (IMS) applications. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient.

FDA本周发布信息

Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

The devices described in this recall are included in the related Letter to Health Care Providers. See the Letter to Health Care Providers for the most current information on these devices.

This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this as a Class I recall, the most serious type of recall. This device may cause serious injury or death if you continue to use it without following the recall instructions.

Affected Product

• Product Names:

• VasoView HemoPro 2 Endoscopic Vessel Harvesting System, VH-4000

• Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System, VH-4001

• Model Unique Device Identifier (UDI)/Model:

• 00607567700406/VH-4000

• 00607567700451/VH-4001

• Lot/Serial Numbers: All unexpired lots.

What to Do  

• Review Instructions for Use before using Vasoview HemoPro 2 EVH devices.

• Read FDA’s Letter to Health Care Providers related   to these devices.

In December 2024, Getinge sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

• Review the safety information provided in the letter.

• Pay special attention to the following warnings from the Instructions for Use (IFU) to     minimize over-delivery of energy.

• When inserting or retracting the Harvesting Tool through the Harvesting Cannula, close the Jaws and ensure the Jaw tips are oriented upwards (concave side up) to prevent damage to the Jaws.

• Application of energy without tissue between the Jaws of the Harvesting Tool should be kept to minimum in order to maximize Harvesting Tool performance.

• When separation of the branch tissue is noticed, open the Jaws and stop application of energy by pushing the Activation Toggle into the forward most position      and retract the Harvesting Tool slightly.

• NOTE: Once material has been transected, stop application of energy.

• Consider the following actions to mitigate risks:

• Inspect the device prior to use for any signs of damage including silicone peeling away from the jaws.

• Check the outer surface of the device for rough surfaces, sharp edges, or unusual protrusions that may be a hazard.

• Monitor the device during use for silicone peeling away from the jaws.

• Inspect the device after use for missing or damaged parts.

• Stop using the device if, at any time of use, there are missing or damaged parts or      peeling of silicone.

• Locate and      remove any fragmented components from the patient.

• Monitor      patients for complications if you suspect fragment(s) of the device may      have been retained. Future complications could include delayed onset of      pain, infection, and/or localized allergic/adverse reaction.

• Complete and     sign the Medical Device Removal Response Form attached to the letter.

• Return the     completed form to Maquet Cardiovascular/Getinge by email:
       Hemopro-peelinq-detached­silicone2024.act@getinge.com or     fax: 1-866-594-8101.

• Forward this information to all current and potential device users within your     hospital/facility.

• Distributors should forward to any customers who may have received this product.

Reason for Recall   

Getinge and its subsidiary Maquet Cardiovascular are recalling VasoView HemoPro 2 (VH-4000 and VH-4001) Endoscopic Vessel Harvesting Systems due to the possibility of two failure modes experienced during use: a bent or detached heater wire and silicone peeling or detaching from the jaws of the harvesting tool.

The use of affected product may cause serious adverse health consequences, including bleeding, burns, injury, or blockage (embolism or occlusion) of blood vessels, infection, and death.

There have been seven reported serious injuries, four for the heater wire and three for silicone peeling or detaching. There have been no reports of death.

Device Use

VasoView HemoPro 2 Endoscopic Vessel Harvesting (EVH) Systems are indicated for use in minimally invasive surgery, allowing access for vessel harvesting. These systems are used for patients undergoing endoscopic surgery to create a new path for blood flow in the arteries (arterial bypass).

FDA本周发布信息

GUIDANCE DOCUMENT

Premarket Approval Application and Humanitarian Device Exemption Modular Review

FDA本周发布信息

Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

• Product Names: Monitoring Service Application for Mobile Cardiac Outpatient Telemetry MCOT (BTPS-1000)

What to Do  

• Check the Philips Prescriber Response Site at https://prs.gobio.comExternal Link Disclaimer to review which patients who had outpatient electrocardiogram (ECG) monitoring may need to have data reprocessed (data collected from July 2022 to July 2024).

On December 18, 2024, Philips sent all affected customers an Urgent Medical Device Correction recommending the following actions:

• Review Philips’s Frequently Asked Questions for this issue (see below).

• Log into the Prescriber Response Site at https://prs.gobio.comExternal Link Disclaimer with the Location Code provided in the letter header.

• Read and acknowledge receipt of the Urgent Medical Device Correction letter on the     website.

• Review your patient list and choose patients for reprocessing.

• Options include reprocessing All, None, or Selected patients.

Philips will not communicate with patients directly about this issue. If patients have been impacted as part of this issue, health care providers have the responsibility to inform patients and/or update a patient’s care pathway.

The firm also provided a list of Frequently Asked Questions for this issue, including:

• How can I identify my impacted patients?

• A list of your patients who have been impacted is included for review in the Prescriber Response Site.

• What is the Prescriber Response Site?

• A secure site (https://prs.gobio.comExternal Link Disclaimer) containing      your impacted patient list.  

• This is also      the site where Philips will post reprocessed ECGs, resulting in either a      Delta Summary Report or a notification that no changes occurred to the      reporting.

• What   actions are required of my clinical practice?

• Log on to the Prescriber Response Site with the provided Location Code and your NPI.  

• Read and acknowledge the receipt of this Urgent Medical Device Correction Letter.

• Review list of patients and select whether you wish reprocessing to be performed on all or none of your patients; you will also be able to select individual specific patients on the site.

• What actions are planned by Philips if I choose to have the Delta Summary     Report generated?

• Philips will generate a Delta Summary Report for the selected patients and send them via the Prescriber Response Site for review.  

• You will be notified via the email provided during the acknowledgement process when      your reports are ready for review.

• How   will newly identified Urgent and Emergent events be handled?

• Newly identified events will be included in the summary report.

• Events newly identified as Urgent or Emergent will not be notified to practices via      routine communication channels.

• Whom do I contact if I become aware of an adverse reaction or quality problem     experienced because of this software configuration issue?

• If you need any further information or support concerning this issue, please contact our Prescriber Response Line at 888-521-1684.

Reason for Correction

Philips and their subsidiary Braemar Manufacturing are correcting the Monitoring Service Application, a service related to Mobile Cardiac Telemetry Monitoring (BTPS-1000)
after identifying that some ECG events received into the Monitoring Service Application from July 2022 to July 2024 were not properly routed. As a result, these events were not reviewed by a cardiology technician for potential reporting to the ordering clinician. This may have led to missing information in reports or missed notifications, both of which could have impacted a health care provider’s clinical decision making.

Some of the ECG events received into the application during this time period met criteria to be escalated back to ordering practitioners, but were not escalated to them. These events include algorithm-identified episodes of atrial fibrillation or pause, supraventricular tachycardia, ventricular tachycardia, and second or third degree AV block.

The use of affected product may cause serious adverse health consequences, including longer periods of undetected or untreated irregular heartbeats (arrhythmias) and death.

The FDA is aware of 109 reported injuries and 2 reports of death related to this issue.

Device Use

The Philips (Braemer) Monitoring Service Application software is intended to process, analyze, display, and report symptomatic and asymptomatic cardiac events in ECG data received from compatible devices. The data is then reviewed by qualified health care professionals. It is not intended for use on patients with potentially life-threatening arrhythmias who require inpatient monitoring.