Consultation outcome

Chapter 1 - Scope of the Regulations

Updated 26 June 2022

The MHRA consulted on amending the scope of the UK medical device regulations. Proposals would bring into scope medical devices and in vitro diagnostic medical devices (IVDs) captured within the Global Harmonization Task Force’s (and/or its successor organisation, the International Medical Device Regulators Forum (IMDRF)) internationally recognised definitions, and account for advances in medicine, engineering or technology. The changes the MHRA consulted upon would also result in some products, previously either unregulated or regulated under different legislation, being brought into scope and others currently regulated as medical devices being removed from scope.

The proposals will improve patient safety by providing greater assurance about the performance and safety of devices, including those with a similar patient risk profile to medical devices but which have no intended medical purpose. Through stronger international alignment, the proposed changes will also provide developers with a more closely aligned set of definitions to work to when considering routes to market for their products.

Section 1 - Medical device and IVD scope

1.1 Proposals

The MHRA consulted on expanding the scope of the UK medical devices regulations to include certain products within the definition of a ‘medical device’.

The MHRA also consulted on expanding the scope of the UK medical devices regulations to amend the definition of an ‘in vitro diagnostic medical device’ (IVD).

In addition, the MHRA proposed that the definition of ‘medical devices’ in the regulations could also be revised so that it refers to ‘disability’ rather than ‘handicap’.

The MHRA consulted on amending the UK medical devices regulations to clarify that ‘intended purpose’ for all medical devices (including active implantable medical devices) and IVDs should be construed objectively, from the standpoint of an objective observer, with reference to both the data supplied by the manufacturer on the labelling, the instructions for use and/or the promotional materials and also other key materials such as a manufacturer’s technical documentation (including clinical evaluation for a medical device).

1.2 Feedback

The consultation invited views on whether the definitions set out in the UK medical devices regulations should be expanded on to include the additions suggested in the consultation text. Of the 464 responses to this question:

• 83% were in favour of expanding the definitions
• 11% were not in favour
• 7% did not know or had no opinion

Respondents were asked to set out what (if any) further amendments should be made to the scope of the UK medical devices regulations. Key themes from free-text responses can be summarised as follows:

• the regulations should provide that dermal fillers must only be administered by healthcare professionals
• dermal fillers should be available on a prescription-only basis
• certain brand name products associated with cosmetic procedures should be brought into scope of the UK medical devices regulations
• further clarity is needed around the regulation of ‘borderline’ products that could potentially fall under more than one regulatory framework to ensure consistent regulation – disinfectant products were cited as an example here

The consultation invited views on whether it should be made clear that ‘intended purpose’ is to be construed objectively and that key materials such as a manufacturer’s technical documentation may be used as evidence of intended purpose. There were 460 responses, of which:

• 83% were supportive of this approach
• 6% were unsupportive
• 10% did not know or had no opinion

Other information provided by respondents in the free text comments on what (if any) further amendments should be made to the scope of the UK medical devices regulations, can be summarised as follows:

• an objective and data-driven approach should be taken
• clarification is needed surrounding the term ‘objective observer’
• genetic tests should have a clear statement of intended use and avoid having broad or vague statements to escape more stringent requirements
• rules should be tightened around disclaimers to ensure they do not result in the evasion of responsibility
• respondents were also in favour of removing the current distinction between active implantable medical devices and general devices, noting that the intended use should be defined based on the same sources of information for each

1.3 The government response

The MHRA has carefully considered all responses to the questions raised in this section and have set out our response below.

The MHRA is responsible for the regulation of medical devices and, as outlined below, intends to bring into scope of the UK medical devices regulations, products for which a manufacturer claims only an aesthetic or another non-medical purpose, but which are similar to medical devices in terms of their functioning and risk profile. This suite of products will include dermal fillers, which will consequently be subject to more stringent regulation.

The MHRA would like to clarify that the MHRA does not have a role in regulating healthcare practitioners, which falls within the remit of the Department of Health and Social Care (DHSC). We recognise the importance of the points raised by many respondents around restricting the administration of dermal fillers to practitioners – however this is outside the bounds of this consultation.

The 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 MHRA has shared the consultation feedback with the relevant DHSC team for consideration as part of this work.

Regarding the points made around regulating dermal fillers as prescription only medicines, the MHRA would like to clarify that, generally, this requirement only applies to medicinal products. The ‘prescription only’ concept does not, as a rule, apply to medical devices. There are a few exceptions to this – for example, specific pieces of UK legislation place restrictions on the sale or supply of specific medical devices (for example, the Opticians Act 1989), however these do not apply to dermal fillers. As not all dermal fillers are classified as a medicinal product, the MHRA is not able to regulate them as a prescription only medicine (unless they do not have a medical purpose but contain a medicinal substance such as an anaesthetic), but rather as medical devices or, in some cases at the current time, general products. MHRA is unable to regulate these as prescription only medicines and will not be able to do so once they are brought into scope of the UK medical devices regulations.

It should be noted that one of the products that was referenced in some responses is a medicine and is regulated as such and is therefore already subject to a high level of scrutiny. Products meeting the definitions that will be set out in the regulations will be brought into scope of the UK medical device regulations.

Regarding the points raised on the regulation of ‘borderline’ products that could potentially fall under more than one regulatory framework, the MHRA provides guidance on this topic and will ensure that it is updated to reflect any changes made to the regulations. The MHRA can advise on borderline cases if manufacturers are unclear about which regulatory pathway applies to their products.

Considering the broad support for the proposals, the MHRA intends to proceed with amending the UK medical devices regulations to amend the definitions of medical devices and IVDs as set out in the consultation. We will also clarify that ‘intended purpose’ is to be construed objectively with reference to the materials listed in the ‘Intended purpose’ section above. The MHRA will also remove the distinction currently made in the regulations between active implantable medical devices and other medical devices. Definitions of any new terms will be provided.

Section 2 - Products without an intended medical purpose

2.1 Proposals and feedback

The consultation invited views on whether the UK medical devices regulations should be broadened to include devices without a medical purpose with similar risk profiles to medical devices, as outlined in the consultation and set out in the list below. Of the 300 responses:

• 87% were in favour, with the majority supporting inclusion of all product types listed
• 7% were unsupportive of this approach
• 6% did not know or had no opinion

There was also strong support for this proposal among the 57 respondents to the abridged consultation (Chapter 17), with:

• 95% favouring the approach outlined in the consultation
• 2% not in favour of the approach
• 4% did not know or had no opinion

Those who answered ‘yes’ to the previous question (in response to Chapter 17) were asked to select the products they considered should be regulated under the UK medical devices regulations from the list below. The percentage rates of the 57 respondents that selected each option are as follows:

1. non-prescription contact lenses or other items intended to be introduced into the eye (89%)
2. products intended to be totally introduced into the human body through surgically invasive means e.g., buttock implant (93%)
3. products intended to be partially introduced into the human body through surgically invasive means e.g., microneedling products (88%)
4. substances intended to be used for facial or other dermal or mucous membrane filling by injection, excluding those for tattooing e.g., dermal fillers (88%)
5. equipment intended to be used to reduce, remove or destroy fat tissue, such as equipment for liposuction (88%)
6. high intensity electromagnetic radiation (e.g., infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body e.g., hair or tattoo removal lasers (81%)
7. equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the skull to modify activity in the brain e.g., transcranial (non-surgically invasive) stimulation (91%)
8. diagnostic tests for health and wellbeing e.g., genomic testing for diet/nutrient optimisation, genomic testing for skin care, lactate testing for fitness training (72%)
9. other (please specify) (5%)
10. don’t know/no opinion (4%)

Respondents to the abridged consultation (Chapter 17) were asked to provide reasoning for their previous answers or any general comments on key considerations for the regulation of products without a medical purpose. The key themes from the 31 responses received can be summarised as follows:

• many respondents reaffirmed their agreement with the approach set out in the consultation
• some noted that the approach would deliver safety benefits
• there was suggestion that we should align with the EU Medical Devices Regulation (2017/745) (EU MDR)

The consultation invited views on whether manufacturers of these products should be required to register them with the MHRA. Of the 286 respondents to the detailed consultation (Chapter 1):

• 89% were in favour of this approach
• 3% were unsupportive
• 8% did not know or had no opinion

The following points were made in the corresponding free text responses:

• cosmetic products, such as dermal fillers, should only be administered/used by healthcare practitioners and should be available on a prescription-only basis
• regulations should be drafted in such a way as to allow some flexibility and future proofing for certain products such as micro-needling and polydioxanone (PDO) threads
• the requirements for such products should harmonise with global standards where possible
• a risk-based approach should be taken
• common specifications should be introduced
• clinical investigation requirements need to be tailored for non-medical purpose products – they are unlikely to be able to demonstrate clinical benefit if manufactured purely for cosmetic purposes

2.2 The government response

The government’s response to comments about the regulation of practitioners administering dermal fillers is set out above, as is our response to the suggestion that dermal fillers should be available on a prescription-only basis.

Further to the proposals outlined in Chapter 7 of the consultation on clinical investigation and performance studies, we intend to require manufacturers of high-risk devices, including Class III medical devices, to publish data on device safety and performance following UK Conformity Assessed (UKCA) marking, for intended users of the medical device in the form of a ‘summary of safety and clinical performance’ (SSCP). This will include information on the medical device’s safety, clinical data, and clinical performance. As part of the SSCP, manufacturers will need to define and set out the suggested profile and training for users, which would then be checked by their Approved Body.

It is considered that this approach, which would enable professional bodies to more effectively monitor these types of devices to determine conformance to their guidelines, will lead to increased transparency. Once all dermal fillers are in scope of the UK medical devices regulations, it is expected that they would become Class III medical devices under existing classification rules for implantable devices (and will not be made into a lower risk class by any of the consultation proposals set out in Chapter 2), and therefore an SSCP will be required for these products.

After careful consideration of the views expressed by consultees and in light of the high degree of support expressed, it remains the government’s intention to proceed with the proposal to expand the scope of the UK medical devices regulations to include the list of product types outlined in a-g of section 2.3 of the consultation text. It is not intended to expand the scope to diagnostic tests without a medical purpose at this time but we will keep this under consideration.

In addition, in light of the positive consultation response, the government intends to require manufacturers of the products covered by this section will register them with the MHRA.

The government notes the points raised around the need for common specifications, clear guidance and clarity on clinical investigation requirements. The MHRA will develop clear definitions and guidance to accompany the regulatory changes and address the issues raised by respondents.

Section 3 - Exclusion of products that contain viable biological substances

3.1 Proposals

The consultation invited views as to whether products which contain or consist of viable biological substances (for example, microorganisms) should be explicitly excluded from the scope of the UK medical devices regulations. The UK medical devices regulations do not explicitly include or exclude medical devices incorporating these products from scope, which has led to confusion.

3.2 Feedback

There were 150 responses in this section, of which:

• 43% were in favour of the approach set out in the consultation
• 23% were unsupportive
• 34% did not know or had no opinion

Respondents also provided a range of comments, which can be summarised as follows:

• there was confusion as to how these products would be regulated if not covered by the UK medical devices regulations
• a number of respondents misunderstood “viable biological substances” to mean, for example, ancillary bioactive coatings or proteins. We would like to clarify that “viable biological substances” here refers to cells that can live, grow and/or reproduce, such as live bacteria
• some respondents sought clarification on how Advanced Therapy Medicinal Products (ATMP) / medical device combination products would be regulated
• there is a need for a precise definition and explanation of what we mean to exclude, to ensure that any exclusions are specific and appropriate (for example, so that we do not rule out bioactive coatings, proteins etc. where these are ancillary components)

3.3 The government response

It is noted that there was a degree of misunderstanding as to what products we intend to exclude. As above, to clarify, the term ‘viable biological substances’ refers to live cells in particular, and not to all products derived from a biological or organic source.

As noted above, the government intends is to amend the UK medical devices regulations so that they are explicit about the exclusion of these other types of viable cell, not just human or animal cells, which will mean that the position is made clearer for manufacturers. There is no intention to set up an exclusion that would target and remove products derived from a biological or organic source which are already appropriately regulated as medical devices.

The MHRA would also like to clarify that, in cases where medicinal claims are made, viable biological substances are currently regulated as medicinal products, so are already subject to a highly scrutinised regulatory route and will continue to receive a high degree of scrutiny.

We will give further consideration to the need for clear definitions and guidance to avoid confusion in future and so that manufacturers can be clear about what is in and out of scope.

We note the points raised about the regulation of ATMP / medical device combinations. We would like to clarify that, where the ATMP function is primary, the product is already regulated as a medicinal product. We recognise that there is a need to clarify the position in cases where the medical device function is primary and will give this matter further consideration.

Section 4 - Exclusion of food

4.1 Proposals

The consultation proposed that food could be explicitly excluded from the scope of the UK medical devices regulations in order to provide clarity and prevent inappropriate regulation.

4.2 Feedback

Of the 128 responses in this section:

• 71% were in support of excluding food from the scope of the UK medical devices regulations
• 10% were unsupportive
• 19% did not know or had no opinion

The key points that were raised in accompanying free-text responses can be summarised as follows:

• agreement that food products should be regulated separately (and not as a medical device)
• there is a need to include a definition of ‘food’ in the UK medical devices regulations
• foods for which specific medical claims are made, such as products that contain probiotics, should be in scope of the UK medical devices regulations
• food products that are used for a special medical purpose, such as high nutrition feeding formula, should be regulated as a medical device
• further consideration should be given to how devices which incorporate food substances are regulated

4.3 The government response

The MHRA does not currently regulate food. In light of the strong support received, we intend to explicitly exclude food from the scope of the UK medical devices regulations to clarify this.

In doing this, we recognise that it will be important that the regulations clearly define ‘food’.

Regarding probiotic products - for clarity, the MHRA intends to explicitly exclude viable biological substances from the regulations, and this will include probiotics. It should be noted that, in cases where medicinal claims are made, probiotic products are and will be regulated as medicinal products and are therefore already subject to a highly scrutinised regulatory route.

Food for special medical purposes (FSMP), such as high nutrition feeding formula, falls within the remit of the DHSC as the lead government department responsible for nutrition policy. FSMPs are governed by the overarching Food for Specific Groups legislation Regulation No 609/2013 and specifically Commission Delegated Regulation 2016/128 which regulates the specific compositional and information requirements for FSMPs. More detailed information on the relevant legislation and on notification procedures can be found at: Nutrition legislation information sheet.

FSMPs are therefore already outside the scope of the UK medical devices regulations and we consider that bringing them into scope could lead to duplication and inappropriate regulation. These products also have a mode of action which excludes them from the definition of a medical device.

Regarding the points raised around medical devices that incorporate food substances, we would like to clarify that if a medical device has a food-derived component it is already regulated as a medical device.