Could aesthetic devices face greater regulation? What providers need to know about the MHRA’s latest proposals

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Could aesthetic devices face greater regulation? What providers need to know about the MHRA’s latest proposals

The regulatory landscape for the aesthetics sector continues to develop.

On 1 September 2026, the Government announced that it had tabled amendments to the Health Bill which, amongst other things, would provide powers for the future introduction of an MHRA licensing regime for medical devices in Great Britain.

No new licensing regime has been introduced at this stage. However, the proposals are another development that those operating within the aesthetics sector should be aware of, particularly given the increasing use of devices and technology in non-surgical cosmetic treatments.

What has been proposed?

The Government has tabled three amendments relating to the regulation of medicines and medical devices.

These include changes to information-sharing powers and provisions intended to allow the regulatory framework to respond more quickly to scientific and technological developments.

Perhaps most significantly, the amendments would also provide the legislative basis for the future development of a medical-device licensing regime.

The MHRA has indicated that it is exploring a model under which certain devices placed on the Great Britain market through a domestic route could require a licence issued by the regulator.

Any future regime is expected to be risk-based, meaning that the level of regulatory scrutiny could vary according to the nature and risk profile of the device concerned.

Is the law changing now?

Not yet.

The proposed amendments are enabling provisions. They do not themselves introduce a requirement for aesthetic clinics or other businesses to obtain an MHRA licence for the devices they currently use.

There would need to be further policy development before any new regime was introduced, together with consultation, impact assessment and parliamentary scrutiny.

Providers should therefore be cautious about interpreting the announcement as the introduction of a new licensing requirement.

Nevertheless, it gives us an indication of the direction in which medical-device regulation may be heading.

Why is this relevant to the aesthetics sector?

When we talk about increased regulation of non-surgical cosmetic procedures, the focus is often on the person carrying out the treatment.

Questions around qualifications, training and competence — and which procedures should only be performed by particular healthcare professionals — are clearly important.

However, that is only part of the regulatory picture.

Aesthetic clinics increasingly use a wide range of devices and technologies when providing treatment. Depending upon their intended purpose and characteristics, some of those products may fall within the medical-device regulatory framework.

Providers therefore need to think not only about who is carrying out a treatment, but also about what is being used to provide it.

That includes understanding where equipment has come from, who manufactured or supplied it, its regulatory status and whether it is being used in accordance with its intended purpose.

What should providers be considering?

There is no requirement for aesthetic businesses to change their practices simply because these amendments have been tabled.

However, providers may wish to use this as an opportunity to review their existing governance arrangements around devices and equipment.

In particular, providers should consider whether they can readily establish:

  • what devices and equipment are being used within the business;
  • who manufactured and supplied them;
  • what regulatory documentation is available;
  • whether equipment is being used for its intended purpose and in accordance with the manufacturer’s instructions;
  • whether practitioners have received appropriate training;
  • whether appropriate servicing and maintenance arrangements are in place; and
  • whether adequate procurement and maintenance records are retained.

Providers should also exercise appropriate due diligence when purchasing equipment.

The fact that a device is available to purchase online, including from an overseas supplier, does not of itself establish that it meets the regulatory requirements applicable in Great Britain.

A wider regulatory picture

This latest development also needs to be considered against the backdrop of wider regulatory reform within the aesthetics sector.

The Government has already signalled its intention to increase oversight of higher-risk non-surgical cosmetic procedures. At the same time, regulators including the CQC, MHRA and GPhC can all have a role depending upon the treatments being provided and the way in which a business operates.

For providers, this demonstrates why regulatory compliance cannot simply begin and end with the practitioner carrying out the procedure.

The regulatory status of medicines and devices, prescribing arrangements, procurement and supply chains, advertising, consent, patient safety and wider clinical governance can all potentially give rise to regulatory issues.

As the sector becomes more heavily scrutinised, providers need to understand not only whether their practitioners are appropriately trained, but whether the systems surrounding the treatment stand up to scrutiny.

What happens next?

The Health Bill continues to progress through Parliament.

Even if the proposed enabling powers become law, a future medical-device licensing regime would still require considerable further development before becoming operational.

The next significant development is therefore likely to be the publication of further policy detail or consultation on how such a regime might work.

Those manufacturing, supplying or using devices within the aesthetics sector should keep developments under review.

For now, there is no new licensing requirement for aesthetic providers.

However, the proposals provide another useful reminder that the regulatory framework surrounding aesthetics is becoming increasingly complex — and that good governance involves looking at the whole treatment pathway, rather than simply the person holding the device.

How JMW can help

JMW’s Business Crime and Regulatory team advises aesthetic practitioners, clinics and healthcare businesses on regulatory compliance and enforcement matters, including issues involving the CQC, MHRA and other healthcare regulators.

If you are concerned about the regulatory status of the services you provide, or require advice regarding an investigation or regulatory action, please get in touch by filling in our enquiry form.

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