Consultation outcome

Chapter 11 - Implantable Devices

Updated 26 June 2022

Implantable medical devices bring with them some unique challenges. Procedures using these devices, either to introduce them or remove them, can be highly invasive. Implantable medical devices are often used for a longer duration than many other types of medical devices and their removal brings additional risks or may not be possible.

The consultation invited views on how implantable medical devices can be better regulated, including proposals to ensure that implantable medical devices receive adequate scrutiny before they reach the market, and to ensure sufficient post-market surveillance and responsiveness to any post-market issues with implantable medical devices. The proposals have potential to improve the overall safety of implantable medical devices.

Section 66 - Implantable devices

66.1 Proposals and feedback

The MHRA invited views on whether there should be any changes to the scope of medical devices regulated as implantables. There were 244 responses, of which:

• 68% were in favour of change
• 17% did not support the possible change
• 15% did not know or had no opinion

There was a difference in the responses provided by individuals and organisations. In both cases, the majority supported the possibility, but with stronger support of changes expressed by individuals (82%), compared to organisations (51%).

When asked to set out any implantable devices that should be brought into or removed from the scope of implantable devices regulated under the UK medical devices regulations, 134 respondents provided comments. Dermal fillers, temporarily implanted medical devices, and breast implants were commonly raised as possible additions to the above scope, and some respondents suggested that ‘all implantable medical devices’ be brought into scope.

Some respondents provided the rationale for their suggested additions. The reasons given for expanding coverage to encompass temporarily implanted devices included a need to ensure sufficient pre-market scrutiny, post-market surveillance, and clinical data to evaluate possible additional risks, side effects and overall enhance patient safety.

Those suggesting that temporarily implanted medical devices be brought in scope commonly reasoned that these devices carry similar risks to other types of implantable medical devices (however, this view was not universal – other respondents were of the opposite view). Many respondents also sought clarification or definition of what products are classified as temporarily implantable medical devices. Those commenting dermal fillers should be brought into scope were largely driven by patient safety concerns, wanting to ensure that such products be made available on a prescription only basis and be limited to administration by medical practitioners. Those calling for breast implants to be brought into scope largely cited patient safety benefits.

A small number of responses proposed possible exclusions from the scope of regulated implantable medical devices, including Ophthalmic Viscosurgical Devices (OVDs). One respondent felt there should be exemptions from requirements for certain implantable devices, such as screws and staples, in line with the approach taken under the EU MDR. A small number made general comments on classification rather than scope. Others noted that the scope of implantable medical devices regulated under UK medical devices regulations should align with EU regulations which could reduce compliance costs for some manufacturers wishing to place devices on multiple markets.

The MHRA invited views on a range of possible changes to pre-market requirements for implantable medical devices, including requirements around clinical investigations, technical documentation requirements and possible exemptions to pre-market evidence requirements.

The consultation also asked whether requirements for clinical investigations should be more robust for implantable medical devices than those conducted for non-implantable devices. Of the 243 responses received:

• 65% were in support of the possibility
• 17% were not in support
• 18% did not know or had no opinion

The consultation invited views on whether requirements for technical documentation for implantable medical devices should be more robust than those conducted for non-implantable devices of the same risk category. Of the 240 responses received:

• 60% supported this proposal
• 18% did not support this proposal
• 22% did not know or had no opinion

There was a difference in the response between individuals (70% were in support and 11% were not in support) and organisations (with 48% in support and 27% not in support).

The consultation invited views on whether there should be exemptions from pre-market evidence requirements for certain implantable devices (for example, screws and wedges). 242 responses were received. Of which:

• 27% were in support of such exemptions
• 32% did not support such exemptions
• 41% did not know or had no opinion

The consultation invited respondents to share their rationale for their response to the above questions on possible changes to pre-market requirements. 128 responses were received. In those no clear rationale was presented. However, common comments included:

• exempting Well Established Technology (WET) and/or aligning with exemptions under the EU MDR (or going beyond EU MDR exemptions, for example, to exempt nails)
• having clear definitions / guidance on exemptions
• considering other international approaches (for example, those of the U.S. Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).

The MHRA invited views on having additional conditions to the introduction of new implantable medical devices to the UK market, including the controls that should be in place, for how long, and to what type of device controls should apply. Key themes in 103 responses included:

• a small number of respondents considered no further controls around implantable devices are needed
• of those that raised possible changes in controls, many comments expressed a desire to limit the availability of implantable medical devices (or specific types of implantable devices such as dermal fillers) to medical practitioners or healthcare settings
• some commented that controls should depend on the risk of a device and not on the fact that it is implantable
• a small number considered that requirements should align with EU requirements, and not surpass EU / US requirements
• a small number raised possible impacts that could result from the introduction of further controls - including device availability and safety, burden on manufacturers (and small and medium sized enterprises (SMEs) in particular), and supporting innovation
• a small number also expressed interest in changes in post-market surveillance requirements for implantable medical devices, including the need for ensuring robust post-market surveillance for implantable devices and identification of long-term issues with a device
• a number raised clinical evidence requirements, including interest in ensuring robust clinical data and technical documentation to support safety and effectiveness of the device, robust post-market clinical follow up, human trials should be carried out and results available to potential implantees
• some interest in increasing the transparency of evidence relating to the safety and performance of medical devices

The consultation also invited views on whether there should be more stringent controls over medical devices. There were 238 responses, of which:

• 71% supported the possibility
• 17% did not support the possibility
• 13% did not know or had no opinion

There was a difference in the responses between individuals (86% in favour and 7% not in favour) and organisations (53% in favour and 28% not in favour), with stronger support of this possibility from individuals than from organisations.

The MHRA asked consultees to indicate which controls in the list below should be introduced in relation to high-risk implantable devices. 63 responses were received and the percentage in favour of each control is set out below:

• administered with proactive follow up with patients (83%)
• being supplied only to medical device users in centres specialising in their use (62%)
• being supplied to medical device users by practitioners with specialist expertise and experience in the treatment of the condition requiring the device (76%)

The consultation invited views on whether any other controls over implantable devices should be introduced. A small number of respondents raised possible additional controls. Among those responses a common comment was that only licenced/approved users should be permitted to implant devices (e.g., dermal fillers, mesh). The following points were also raised:

• need for better implant traceability, with patient cards and better records kept by healthcare professionals
• longer/lifelong patient follow-up should be put in place for recipients of implants
• an obligation should be on manufacturers to hold funds specifically for compensation purposes
• potential for tighter controls to stifle innovation
• extension of the period for which manufacturers are required to provide device replacement parts for discontinued devices

The MHRA set out that the UK medical devices regulations could be amended to require manufacturers of implantable devices to provide patient implant information with the medical device when placing it on the market, in both digital and physical card or leaflet format. The consultation outlined that health institutions could be required to make this information available to patients having implantable devices both during the process of seeking informed consent to a procedure for an implant, and at the point where a procedure introducing an implant has been completed. It suggested that the UK medical devices regulations could require health institutions to hold this information securely and to log this information in patient records.

The consultation invited views on whether post-market requirements for implantable devices could be enhanced by clarifying or strengthening the requirements around use of obsolete models of implantable medical devices. Out of 238 responses received:

• 64% supported this proposal
• 13% did not support this proposal
• 24% did not know or had no opinion

The consultation also asked whether post-market requirements for implantable medical devices could be strengthened by introducing a requirement for implant information to be provided to recipients of implantable devices. Out of the 239 responses received:

• 79% supported this proposal
• 7% did not support this proposal
• 14% did not know or had no opinion

The abridged consultation in Chapter 17 invited views on whether the UK medical devices regulations should include requirements for manufacturers and health institutions to provide patients with implant information. Of the 72 responses received:

• 88% supported this proposal
• 0% did not support this proposal
• 13% did not know or had no opinion

The consultation asked whether the UK medical devices regulations should require manufacturers of implantable devices to provide implant information for recipient patients with the device when placing it on the market, as set out in the consultation text. Of the 240 responses received:

• 77% supported the proposal
• 8% did not support the proposal
• 15% did not know or had no opinion

The consultation also invited views on whether manufacturers should be required to provide implant cards/leaflets to healthcare settings/professionals. Of the 255 responses received:

• 83% were in favour of the proposal
• 7% were not in favour of the proposal
• 10% did not know or had no opinion

The consultation invited views on what information could be included in implant cards and patient leaflets for implantable medical devices. A range of ideas shared by the 135 respondents to this question, including

• describing the nature of device
• contact details, such as contact points for issues with a device
• the facility, physician
• the date related to the implantation of the devices
• size and duration of device
• risks and adverse events (associated with a device)
• side effects
• supporting evidence
• possible implant alternatives
• information on redress should adverse events arise
• information on the intended use
• instructions relating to use of the device
• complication rates
• composition of the device
• how to report via the Yellow Card scheme
• patient contraindications
• place of manufacture
• batch number
• safety checks that have been undertaken
• common interactions between the device and the body or medicines
• after care advice and side effects
• safety data
• information contained in a medical passport
• implant card information as defined in guidance document EU MDCG 2019-8
• this should be similar to drug information leaflet

When asked the same question in the abridged consultation (Chapter 17), 19 respondents raised the following themes:

• components and materials used in the implantable medical device
• risks and benefits associated with the implantable medical device
• manufacturer contact information to request more information

Some respondents to the main consultation were unsupportive of requiring that manufacturers produce a leaflet to accompany an implant, noting that it would be difficult for a manufacturer to provide this ‘direct’ (which we understand to mean directly to a person being implanted with a device) at the pre-implant stage as the clinician may not select the specific implant until the time of surgery.

The consultation also asked whether manufacturers should be required to make available implant information in both physical and digital formats. Out of the 232 responses received:

• 72% supported the proposal
• 11% did not support the proposal
• 16% did not know or had no opinion

The consultation asked whether the manufacturer should be required to update the digital implant information where appropriate. Of 229 responses received:

• 83% supported the proposal
• 5% did not support the proposal
• 12% did not know or had no opinion

The consultation invited views on whether health institutions should be required to make the information outlined in the consultation text available to patients who have been implanted with the device. 232 responses were received, of which:

• 84% were in favour
• 5% were not in favour
• 11% did not know or had no opinion

Consultees were asked whether health institutions should be required to log the implant information onto the records of the patient implanted with the device. Of the 233 responses received:

• 86% supported the proposal
• 18% did not support the proposal
• 22% did not know or had no opinion

The consultation asked whether any implants should be excluded from the requirements to have accompanying implant information. 235 responses were received, of which:

• 25% supported the proposal
• 43% did not support the proposal
• 32% did not know or had no opinion

There was a difference in the response views between respondents who identified as individuals (12% supported the proposal and 58% were not in favour) and those representing organisations (41% supported the proposal and 25% were not in favour).

Respondents were also invited to outline the types of implants that they considered should be excluded from the requirements to have accompanying implant information and their reasoning for this. Of the 57 responses:

• many were in favour of aligning with exemptions in the EU MDR or certain exemptions set out in the EU MDR
• some respondents proposed specific possible exemptions including for: dental plates and screws, absorbable implants, and nails

Respondents to the abridged consultation (Chapter 17) were asked to provide their reasoning for their answers on patient implant information or any general comments on patient implant information. The following themes were raised by 19 respondents:

• information provided directly to patients should be simple and signpost more detailed electronic information
• the information provided should be published by an independent and unbiased source

The MHRA invited views on whether there is further information that could be captured and share about implantable medical devices in particular. Of 222 responses received:

• 31% were of the view that there is further information we should collect and share about implantable medical devices
• 23% were of the view there is not further information should be captured and shared
• 46% did not know or had no opinion

The consultation asked respondents to set out the rationale for their response to the above question. Across 87 responses to this there was:

• interest in sharing information, including on UDI, device performance, device safety, adverse events, and device complications
• interest in having an accessible central source of safety information / registries.
• some device specific concerns raised, including regarding dermal fillers, mesh and silicone devices.

The consultation asked respondents to share views on implementation considerations for bringing in the changes to the regulation of implantable medical devices raised in this chapter of the consultation. A small number of respondents shared views, including:

• interest in aligning with EU regulations
• in terms of transition to future requirements, take lessons from EU implementation, allow sufficient time for transition, allow for phased implementation, and further consult with professional regulators before enacting changes
• dermal fillers should be on a prescription only basis and administered by healthcare professionals
• regarding equivalence, there were mixed views, with some respondents suggesting that the option to claim equivalence to predicate devices as part of the clinical evaluation process be removed and others noting that equivalence is necessary in terms of servicing small clinical populations and reducing burden on assessors. Equivalence is covered in more detail in Chapter 7 on Clinical Investigations and Performance Studies.

The MHRA invited respondents to highlight any other considerations on the regulatory framework for implantable medical devices. We received wide-ranging feedback from 78 respondents, including:

• interest in aligning with the EU, FDA or other international regulations,
• requests for guidance/clarification on the pathway for dealing with obsolete devices that need revisions
• post-market surveillance considerations for implantable devices, including: the data collection systems used by stakeholders to collect performance date for implantable devices, the methodology for follow up, the need to ensure robustness and meaningful analysis, financial and resourcing impacts for health institutions who manufacture up to class IIb devices, and parallel imports
• concerns on proposed equivalence requirements
• interest in a controlled market release for new devices
• interest in having an exemption list for the requirement for implant information to accompany implantable medical devices

Finally, the consultation also invited respondents to provide any additional information relating to questions relating to regulation of implantable medical devices contained in Section 66. The consultation received 61 responses to this ask, which included:

• agreement with the possible additional requirements applying to implantable medical devices set out in the consultation
• desire to seek alignment with the EU MDR, or approaches in other jurisdictions
  concern about the impact of implant card requirements on health institutions and capacity to implement them
• concern about the implementation period for these requirements and suggestion that longer transition timescales are needed

66.2 The government response

The government has carefully considered the consultation feedback relating to the potential expansion of scope of implantable medical devices regulated under the UK medical devices regulations. It is considered that the products proposed by respondents are either already in scope of the regulations or there is no strong rationale for amending the scope to include or remove them. The government does not plan to introduce any changes to the scope of medical devices regulated as implantable medical devices at this time. Below are some key considerations on suggestions raised:

• include dermal fillers – dermal fillers are already in scope of the UK medical devices regulations where they have an intended medical purpose. The government recognises the strong interest and merits of expanding the regulations to include dermal fillers without a medical purpose – see more detail in the Scope chapter of this response (Chapter 1)
• include breast implants - breast implants are already in scope of the regulations
• include temporarily implanted medical devices – currently, by reference to Directive 93/42, to be classified as implantable medical devices in under UK medical devices regulations must be intended to remain in place in the human body for at least 30 days after the surgical procedure. Further consideration is needed of the extent to which temporarily implanted medical devices are in scope to determine whether any changes to it are warranted.
• there was no clear rationale provided by respondents for excluding ophthalmic viscosurgical devices (OVDs) from the scope of regulated implantable medical devices
• exemptions from requirements – this is considered separately below.

The government has carefully considered the points raised on possible changes to pre-market requirements for implantable medical devices. It is noted that changes in classification (expanded on in the Classification and IVD Chapters) will have implications for the level of scrutiny a device undergoes. In addition, it is intended to strengthen clinical evidence requirements for all medical devices, including implantable devices, as set out in the chapter on clinical investigation and performance studies (Chapter 7). See also the Conformity Assessment Chapter for enhancements to how Approved Bodies will review implantable medical devices in particular. After careful consideration, we do not consider at this time that further implantable-specific requirements are warranted to technical documentation and clinical evidence requirements.

It is recognised that a number of respondents showed interest in having certain exemptions to clinical evidence requirements for specific implanted devices such as screws and wedges. This included interest in aligning with exemptions that apply in the EU or the US. However, no strong rationale for these exemptions was presented. Following careful consideration, it is not intended to introduce exemptions from clinical evidence requirements at this time for any types of implantable devices on the basis they are of a certain type (e.g., screws and wedges). While mindful this differs from the approach taken elsewhere, for example in the EU, it is considered important to assuring the safety and performance of implantable devices.

The government has also carefully considered consultation feedback on whether there should be more conditions on the introduction of implantable medical devices, including interest in the following possible controls:

• that implantable medical devices should be administered with proactive follow up with patients
• that such devices should be supplied only to medical device users in centres specialising in their use
• that such devices should be supplied to medical device users by practitioners with specialist expertise and experience in the treatment of the condition requiring the device
• making dermal fillers available on a prescription only basis
• requiring dermal fillers be administered by health practitioners, as noted in the Scope Chapter (Chapter 1).

Regarding making dermal fillers available on a prescription only basis, please see the Scope Chapter (Chapter 1) for detail of our response. Regarding respondents’ interest in requiring dermal fillers be administered by health practitioners, as noted in the Scope Chapter (Chapter 1). the regulation of practitioners falls within the remit of the Department of Health and Social Care (DHSC). DHSC has recently announced its intention to strengthen the regulation of cosmetic procedures, specifically through proposals to introduce a licensing regime for non-surgical cosmetic procedures such as injectable Botulinum toxin (for example, Botox®) and fillers: Government to crack down on unregulated cosmetic procedures. The consultation feedback has been shared with the relevant DHSC team, for consideration as part of this work. It is considered that proactive follow up of patients will be strengthened through the post market surveillance measures intended to be introduced that will apply to implantable medical devices (set out in Chapter 8 Post Market Surveillance).

After careful consideration of the responses received, and implications of implantable medical devices being supplied via centres specialising in implantable devices use, the government acknowledges the interest in this proposal but is of the view that this would require more detailed consideration and scoping before introducing such a change.

After careful consideration, the government intends to take forward a number of measures that were raised by respondents, including:

• measures to improve implant traceability, including through the introduction of requirements for implant information. See below in this section for further detail on plans to introduce requirements for implant information. See the UDI and Registration chapter (Chapter 4) for information on traceability more broadly.
• reducing the ability for manufacturers to rely on equivalence to a predicate device as part of the pre-market approval process for implantable medical devices (see the Clinical Investigation and Performance studies Chapter for further detail of the government’s position on equivalence)
• requiring longer/lifelong patient follow-up for recipients of implants (see the post-market surveillance chapter (Chapter 8) for further detail on measures that will be taken forward to strengthen follow up on implantable medical devices)
• considering introducing clearer requirements for seeking informed consent for patients (to the extent this relates to clinical investigations and performance studies, as set out in Chapter 7)

A number of suggestions made by respondents will not be taken forward by the government at this time. Some respondents showed interest in better records being kept by healthcare professionals. This is outside the MHRA’s remit as it relates to the regulation of health practitioners. In addition, it is not intended to require manufacturers to set aside funds specifically for compensation purposes. Instead, as set out in Chapter 3 on Economic Operators, manufacturers will be required to have in place sufficient financial coverage to respond in the event of an adverse incident.

In relation to post-market requirements, there was strong support for requiring that implant information be provided to recipient patients, and support for the proposed implant card and leaflet requirements set out in the consultation. The government therefore intends to take forward these proposals. Respondents signalled strong support for requiring manufacturers of implantable medical devices to provide implant information for recipients of an implanted medical device with the device when placing it on the market as set out in the consultation and requiring manufacturers to provide implant cards/leaflets to healthcare settings/professionals. Consultation respondents’ suggestions for information that should be included were largely captured in the list proposed in the consultation. The government considers that the remaining suggestions could be adequately captured in supplementary guidance, which would provide clear, practical examples of information that could be included in implant information cards/leaflets.

After careful consideration of responses following proposals, it remains the government’s intention to proceed with the following requirements concerning implant card information:

• requiring implant information to be provided to recipients of all implantable medical devices
• requiring manufacturers of implantable devices to provide implant information for recipient patients with the device when placing it on the market, as set out in the consultation
• requiring a manufacturer to provide implant cards and leaflets for healthcare settings/professionals
• requiring manufacturers to make available, implant information in both physical and digital formats
• requiring health institutions to make this information available to patients who have been implanted with the device
• requiring that health institutions log the implant identification information, such as the UDI number (if any), onto the records of the patient implanted with the device.

Of those respondents that expressed a view on whether there should be exemptions to implant card requirements, the majority were in favour of there being no exclusions from this requirement. The government notes there was some interest in exclusions to the requirement to provide implant information to patients in receipt of an implantable medical device. The government is minded to create limited exemptions to the requirements for implant information (as set out in the consultation) for certain devices, being:

• exempt implantables: non-resorbable sutures and staples and dental fillings
• exempt non-implantables: dental braces, tooth crowns

These exemptions are considered warranted as it would not be proportionate to their risk or workable in practice to require implant information for these devices, in light of the scale on which these products are used.

The government recognises the value in having clear and transparent information about implantable devices and their use captured and shared and has outlined a number of measures in other sections of this response which will further this. See Chapter 4 on Registration and UDI. In addition, further consideration will be given to how obsolete implantable devices are regulated. More detailed work would be needed to look at precisely what changes would be beneficial and to quantify their possible impacts before making a specific change here.

The government also recognises the value in ensuring robust post-market follow up of implantable medical devices use. As outlined in Chapter 8, it is intended to introduce more stringent post market follow up requirements that will apply to implantable medical devices.

In light of consultation feedback, while not looking to introduce it at this time, the government has also identified a need to consider further, the potential for requiring a manufacturer to provide device replacement parts for a longer period of time after a device has been discontinued (i.e., has become obsolete).

The government notes the other considerations raised by consultees such as the clear call for guidance, adequate transition time, and a preference for EU alignment. These will be taken into account when progressing plans set out in this response for the future regulation of implantable medical devices. See also Chapter 15 on Transitional Arrangements for more information concerning transition arrangements.