Consultation outcome

Chapter 8 - Post-market Surveillance, Vigilance, Market Surveillance

Updated 26 June 2022

The consultation proposed changes to the medical devices regulations to set out clearer requirements for the manufacturer’s post-market surveillance system and to require the manufacturer to summarise and report their post-market findings to the MHRA. Existing requirements are laid out in guidance. However improved regulation will help to achieve better harmonisation across manufacturers placing devices on the UK market.

The proposed changes will improve the ability of both the manufacturer and the MHRA to identify issues with a medical device and, where necessary, take appropriate action to safeguard public health. This will help improve patient safety and strengthen the level of post-market surveillance activities conducted across all manufacturers placing medical devices on the UK market.

Section 48 – Post Market Surveillance

48.1 Proposals and feedback

The consultation invited views on whether manufacturers should be required to implement a post-market surveillance system based on a post-market surveillance plan, which collates and utilises information from a range of sources such as those listed in the consultation text. Of the 267 responses:

• 93% supported the proposal
• 4% did not support the proposal
• 3% did not know or had no opinion

The consultation also sought views on whether the UK medical devices regulations should provide a detailed outline of what the post-market surveillance plan should address. 267 responses were received, of which:

• 87% were in favour of the proposal
• 10% were not in favour of the proposal
• 3% did not know or had no opinion

We invited consultees to outline any other elements that they considered a post-market surveillance plan should address. Feedback from the 144 respondents can be summarised as follows:

• aligning with the EU would provide economic and operational benefits to manufacturers
• patient involvement should be outlined within the post-market surveillance plan
• details as to what should be included should be outlined in guidance
• the level of detail required should be determined using a risk-based approach

When asked whether the UK medical devices regulations should outline what should be included in the post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) plan, 253 responses were received, of which:

• 80% were in support of this proposal
• 12% did not support this proposal
• 8% did not know or had no opinion

On whether manufacturers should be exempt from the requirement to perform PMCF/PMPF for a medical device or in vitro diagnostic medical device (IVD) pursuant to a PMCF/PMPF plan if such manufacturers provide sufficient justification, 255 responses were received, of which:

• 67% supported this proposal
• 22% did not support the proposal
• 16% did not know or had no opinion

We asked consultees whether the UK medical devices regulations should include requirements for manufacturers to summarise and present the information from their post-market surveillance activities in a post-market surveillance report or a periodic safety update report. 256 responses were received, of which:

• 83% supported this proposal
• 11% did not support this proposal
• 6% did not know or had no opinion

On whether manufacturers should upload post-market surveillance data to the MHRA devices register upon registration renewal, 254 responses were received, of which:

• 63% were in support of the proposal
• 35% did not support the proposal
• 13% did not know or had no opinion

We The consultation invited respondents to provide reasoning for their answers in Section 48. Feedback from the 155 respondents can be summarised as follows:

• many commenters felt that Class I devices should be subject to such reports
• some commenters felt that these requirements should be required for all devices
• distinguishing between the requirements placed on high and low risk devices is a proportionate approach and places less burden on manufacturers and Approved Bodies
• aligning with the EU would provide clarity for manufacturers and end users
• requiring uploading of data could duplicate work and increase burden on manufacturers
• requiring uploading of data could improve transparency within the system
• the current system is operating effectively

48.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to amend the UK medical devices regulations to clarify and strengthen the requirement for manufacturers to implement a post-market surveillance system, in respect of all medical devices they have placed on the UK market. We intend to provide an outline of what this should address within the regulations.

Some respondents also indicated that more guidance may be necessary to ensure patient involvement and address device-specific issues. The government aims to further clarify the requirements of post-market surveillance plans in published guidance.

Section 49 – Reporting of serious incidents and field safety corrective actions (or ‘FSCAs’)

49.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should include requirements for manufacturers to report incidents and FSCAs to the MHRA including points (a) and (b) below:

1. any serious incident, including those which are expected side effects (for example, those listed in the instructions for use)
2. any FSCA (see Section 47), including any FSCA undertaken in a non-UK country in relation to a medical device which has also been made available on the UK market.

241 responses were received, of which:

• 85% supported the proposal
• 12% did not support the proposal
• 3% did not know or had no opinion

The consultation invited views on proposed definitions for ‘serious incident’, ‘serious deterioration’ and ‘serious public health threat’ which were set out in the consultation text. Of 241 responses received:

• 87% supported the proposed definitions
• 10% did not support the proposed definitions
• 3% did not know or had no opinion

The consultation invited respondents who did not support the proposed definitions to outline what they would change about the definition. Feedback from the 61 respondents included:

• definitions should mirror EU MDR/IVDR
• definitions should mirror those for licensed medicines as closely as possible
• definitions should cover mental health impacts

The consultation asked whether the manufacturer should be required to report any serious incident in line with the time periods outlined in points (a) to (c) below:

a) 2 days after they become aware of the incident, in the event of a serious public health threat

b) 10 days after they become aware of the incident, in the event of death or an unanticipated serious deterioration in a person’s state of health

c) 15 days after they become aware of any serious incident which is not covered under parts (a) or (b) above.

239 responses were received, of which:

• 85% supported the proposal
• 12% did not support the proposal
• 3% did not know or had no opinion

Written comments regarding alternative timeframes for reporting serious incidents and other suggested changes to the criteria for reporting serious incidents and field safety corrective actions were received from 70 respondents. Key themes can be summarised as follows:

• definitions should cover life-changing effects
• guidance documents may need to define additional terms such as ‘chronic’
• aligning with the EU would provide consistency for manufacturers and patients
• mental health impacts should be covered as a part of serious incident reporting

The consultation invited views on whether the UK medical devices regulations should specify further procedures for manufacturers regarding the reporting of serious incidents and FSCAs including (but not limited to) points (a) to (c) below:

a) the manufacturer can submit an initial report that is incomplete followed up by a complete report

b) manufacturers must report any field safety corrective actions in advance of the field safety corrective action being undertaken, except in cases of urgency

c) manufacturers can provide periodic summary reports instead of individual serious incident reports for serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action that has been implemented, or where the incidents are common and well documented, where agreed by the MHRA

Of the 235 responses:

• 76% were in favour of the proposal
• 16% were not in favour of the proposal
• 8% did not know or had no opinion

The consultation invited respondents to outline any other requirements which they considered should be introduced regarding reporting of serious incidents and field safety corrective actions. The 86 responses can be summarised as follows:

• serious incident reporting / field safety notice (FSN) / FSCA data should be available to Approved Bodies
• aligning with global standards will provide further clarity to manufacturers
• wording on timescales must be clear to ensure that patient safety is not jeopardised
• manufacturers should be required to include the Unique Device Identification (UDI) when reporting (see Chapter 4 on UDI-DI)
• guidance on the process for submitting FSNs to the MHRA is required to improve clarity

The abridged consultation in Chapter 17 invited views on whether manufacturers should be required to consult with patients when investigating device incidents. Of the 58 responses received:

• 57% supported the proposal
• 26% did not support the proposal
• 17% did not know or had no opinion

Those who supported the above proposal were invited to comment on how manufacturers should consult with patients when investigating incidents. The following themes were raised by the 26 respondents:

• the majority of respondents felt that engagement should be via a third party – with some suggestions to do so through formal patient groups or a patient engagement advisory committee
• some felt that manufacturers could contact patients or a sub-set of patients utilising a database of all patients implanted with a medical device

Respondents to the abridged consultation in Chapter 17 were asked to provide their reasoning for their answers to the previous two questions or any general comments on patient and public engagement during incident investigation. The following themes were raised by the 24 respondents:

• concerns about the practicality of requiring manufacturers to contact patients directly
• the importance of patient engagement and having a means for patients to feedback on their experiences

49.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to amend the UK medical devices regulations to include the definitions of ‘serious incident’, ‘serious deterioration’ and ‘serious public health threat’. The government acknowledges the support for the introduction of the definitions proposed in the consultation. However, upon review of the responses, the government has decided to amend the definition of ‘serious incident’ by replacing “the permanent or temporary serious deterioration of a patient’s, user’s or other person’s state of health” with the “serious deterioration of any person’s state of health”. We consider that that the terms “permanent” and “temporary” are superseded by the definition of “serious deterioration” (as defined in the consultation).

The government notes the comments made around the inclusion of mental health impacts in serious incident reporting and considers that, at this time, appropriate mechanisms are not in place to sufficiently regulate the inclusion of these impacts. The government does however acknowledge the seriousness of such impacts and will keep this issue under review to consider again following a suitable period for the new system to bed in. The government aims to further clarify the requirements in published guidance. The government also acknowledges the suggestion that the definitions should mirror those set out in the EU regulations. The proposed definitions are closely aligned however, the amendments outlined in this section, are intended to provide additional clarity.

Section 50 – Trend Reporting

50.1 Proposals and feedback

The consultation invited views on whether manufacturers should be required to report any statistically significant increase in the frequency or severity of incidents/erroneous results as set out in points (a) and (b) below.

a) for general medical devices and IVDs - any statistically significant increase in the frequency or severity of incidents that could have a significant impact on the benefit-risk analysis

b) for IVDs - any significant increase in expected erroneous results established in comparison to the stated performance of the IVD or respective assays.

Of the 219 responses received:

• 76% supported the proposal
• 16% did not support the proposal
• 8% did not know or had no opinion

When asked to provide reasoning for their answer to the above question, 121 respondents provided comments, which can be summarised as follows:

• this requirement would improve public awareness, safety and promote design improvements
• reporting in this way will have a more significant impact on low-volume devices
• this should be included within the post-market surveillance reporting system to avoid additional manufacturer burden
• trend analysis allows for earlier reaction to issues
• clarity is needed on this requirement to ensure that trend reports can be correctly submitted

50.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposal to amend the UK medical devices regulations to require manufacturers to report statistically significant data as outlined in Section 50.1 above. The government acknowledges the concerns raised that this may disproportionately affect low-volume devices and will consider this in additional published guidance and wider policy development.

Section 51 – Analysis of serious incidents and field safety corrective action (or ‘FSCAs’)

51.1 Proposals and feedback

The consultation sought views on whether manufacturers should be required to issue field safety notices (FSNs) as part of their field safety corrective actions and to submit the content of the FSN to the MHRA for comment, except in cases of emergency. Of 228 respondents:

• 81% supported the proposal
• 12% did not support the proposal
• 7% did not know or had no opinion

When asked whether the UK medical devices regulations should set out the minimum requirements for the content of field safety notices issued by manufacturers, 228 respondents provided views, of which:

• 91% supported the proposal
• 5% did not support the proposal
• 4% did not know or had no opinion

The consultation sought views on whether the MHRA should be required to notify the manufacturer or their UK Responsible Person of new risks it has identified through active monitoring of data in cases where these risks have already been subject to public disclosure. Of 230 respondents:

• 91% supported the proposal
• 6% did not support the proposal
• 3% did not know or had no opinion

The consultation asked: “if the MHRA were to mandate patient and public involvement and engagement in the medical device regulations, as part of manufacturers vigilance obligations, what form should this take?”. Written comments provided by 146 respondents can be summarised as follows:

• this should be outlined in MHRA guidance
• International Organization for Standardization (ISO) standards should be taken into account
• patient Involvement should be a required for all devices
• data collection methods put forward included questionnaires, patient surveys, focus groups and interviews

The consultation invited consultees to indicate what stages they would expect manufacturers to engage patients and the public. 217 respondents selected the options below from a multiple-choice list, as follows:

1. periodically once their medical device is on the market (34%)
2. only when they or the MHRA becomes aware of a safety issue with the device (36%)
3. other – please specify (30%)

Feedback provided in relation to the ‘other’ option can be summarised as follows:

• throughout the product life cycle
• only where patient populations are willing and able to engage
• immediately after a patient reports an incident

When asked respondents to provide reasoning for their answer to the above questions, 126 respondents provided comments, which can be summarised as follows:

• align with EU MDR and IVDR
• patient and public involvement should not be mandated
• the MHRA should make available a template for FSNs
• ongoing vigilance should provide much better underpinning of patient safety

51.2 The government response

After careful consideration of responses, it remains the government’s intention to proceed with the proposals to amend the UK medical devices regulations to require manufacturers to issue field safety notices (FSNs) and to amend the regulations to include the minimum requirements for the content of the FSN. This is to ensure that all FSNs are drawn up to the same standard and that they contain all the information that the MHRA considers important. The government acknowledges the support for the proposal to introduce the requirement for manufacturers to submit the content of their FSN to the MHRA for comment, except in cases of emergency. Appropriate systems need to be available to deliver this, which are not yet in place, therefore this requirement is suspended for future consideration.

The government acknowledges the support to introduce the proposal that the MHRA should be required to notify the manufacturer or UK Responsible person of new risks it has identified through active monitoring of data, it is the government’s intention to proceed with this proposal. The government has noted the support and concerns raised in relation to the proposal to introduce a requirement to mandate patient and public involvement as part of vigilance obligations. Upon review of the responses, it is the government’s intention not to proceed with the proposal to mandate patient and public involvement as part of vigilance obligations however, the government intends to publish guidance to manufacturers on engaging with patients and the public as part of vigilance obligations. The government acknowledges that patient and public engagement as part of vigilance obligations must be proportionate to the risks and intended use associated with a particular device.