Borderline products and the new UK Medical Device Regulations: what’s changing?
The MHRA intends to bring certain aesthetic and another non-medical purpose products under the scope of the UK medical devices regulations for the first time. They intend to do this where the product function and risk profile are seen as being similar to medical devices. This short article is intended to inform manufacturers and to support them in checking to see whether their products are affected.
Regulatory classification (Borderlines)
Certain products are hard to distinguish from one another and may appear to fall within scope of different legislative frameworks (examples: cosmetics, medical devices, medicines). Such products are called borderline products and sometimes their regulatory status must be decided. This can be an outcome from authority advice or it may also result from authority ruling after a stakeholder complaint.
First of all, so that manufacturers can determine the correct classification for their products, the following points must be considered:
- The intended purpose of the product taking into account the way the product is presented
- The method by which the principal intended action is achieved .
- Product claims (explicit and implicit), presentation and promotion.
- Whether there are any similar licensed or registered products on the market and whether they have already been ruled upon.
The MHRA and UK Regulations
In the UK, the MHRA (UK Competent Authority) determines whether a product falls within the definition of a medical device (or a medicine). In the case of a medical device, the principal intended action is typically fulfilled by physical means (including mechanical action, physical barrier, replacement of, or support to, organs or body functions). Until now under UK Regulations, only products with a medical purpose could be considered as medical devices.
Since the UK left the European Union (Brexit), the UK Government has indicated changes to the UK’s regulatory framework for medical devices are coming. The changes are intended to provide better assurance and oversight on the safety and quality of devices (and certain other products) when they are placed on the UK market. They are also intended to ensure that the UK is better aligned with International best practice. This dovetails with the Secretary of State’s overarching objective of safeguarding public health when making regulations under section 15 of the Medicines and Medical Devices Act 2021 (MMD Act).
Accordingly, the Medicines and Healthcare products Regulatory Agency (MHRA) recently consulted on proposed changes to the UK Medical Device Regulations and that process ran between September and November 2021. The UK Government then published their response to consultation on 26th June 2022.
One of the outcomes was a greater indication of the previous intention to include products with a similar patient risk profile to medical devices but which have no intended medical purpose.
Whilst the new Regulation text has yet to be published, the following information can only be construed as being ‘indicative’, but we cannot ignore the increased precision in the following list.
UK Medical Device Regulations: new scope of products
The following products are now intended to be included under the scope of UK Medical device regulations, for the first time.
- Non-prescription contact lenses or other items intended to be introduced into the eye. [Example: Non-prescription coloured contact lenses]
- Products intended to be totally introduced into the human body through surgically invasive means. [Example: buttock implant]
- Products intended to be partially introduced into the human body through surgically invasive means. [Example: micro needling products]
- Substances intended to be used for facial or other dermal or mucous membrane filling by injection, excluding those for tattooing. [Example: dermal fillers]
- Equipment intended to be used to reduce, remove or destroy fat tissue. [Example: equipment for liposuction]
- High intensity electromagnetic radiation (e.g., infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body. [Example: hair or tattoo removal lasers]
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the skull to modify activity in the brain. [Example: transcranial (non-surgically invasive) stimulation]
Of course, we have already seen such products falling within scope of the new EU MDR in Europe so this is not too much of a surprise. It may only be that way for UK manufacturers who do not yet realise these changes are coming. We also expect common specifications to be published for these products in due course.
If you have any questions on these or any other borderline products, you can email Matthew Burton (Strategic Development Director, IMed Consultancy Limited) firstname.lastname@example.org and/or email@example.com
The MHRA can ultimately advise on borderline cases if manufacturers are unclear about which regulatory pathway applies to their products.
Strategic Development Director