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Dermal Fillers are a Class III Medical Device

Currently, there are still too few restrictions on who can perform non-surgical cosmetic procedures, including dermal filler injections. 

There are 3,924 registered clinics in the UK with an annual growth of 8.4%

Dermal fillers are injectable substances designed to add volume and improve facial aesthetics. Common types of fillers include:

  • Hyaluronic Acid (HA) Fillers
    Popular brands like Juvederm and Restylane use HA, a naturally occurring substance in the body. These fillers are reversible using an enzyme called hyaluronidase.
  • Calcium Hydroxylapatite Fillers
    Products like Radiesse use this biocompatible substance, which stimulates collagen production.
  • Poly-L-Lactic Acid Fillers
    Brands like Sculptra work by encouraging the skin to produce its own collagen over time.

Unlike Botox, dermal fillers are not classified as prescription-only medicines (POMs) in the UK, meaning they can be administered without a prescription. This distinction has significant implications for who can legally perform these treatments.

In the UK, dermal fillers are currently categorised under different frameworks depending on their composition and intended use, but generally, they are not as strictly regulated as other medical procedures. 

The Botulinum Toxin and Cosmetic Fillers (Children) Act 2021 made it illegal to administer these treatments to those under 18 in England for cosmetic purposes. 

There are ongoing discussions and proposals to introduce stricter licensing and regulation for practitioners and premises offering cosmetic procedures, including dermal fillers, to improve safety and standards within the industry. 

Technically, anyone can administer dermal filler – though this does not mean that anyone should. 

While dermal fillers are not as strictly regulated as some other medical procedures, there is a growing movement to tighten regulations, particularly around practitioner qualifications, premises standards, and advertising practices. 


The UK government regulates medical devices through its Medicine and Healthcare products Regulatory Agency (MHRA). As such, the MHRA is responsible for the regulation of fillers.

Patients are encouraged to research practitioners and treatments thoroughly, ensuring they choose a reputable and qualified professional. 

Why dermal fillers are safer in the hands of Registered Medical Practitioners

For Medical Practitioners, the General Medical Council (GMC), General Dental Council (GDC), and the Nursing and Midwifery Council (NMC) can sanction any member who doesn’t comply. Falling foul of the regulations could result in practitioners losing their licence and being struck off their register. Therefore they are more likely to follow strict guidelines of safety, efficacy and ethically. As well as having to have professional indemnity insurance (for example, medical malpractice insurance) that covers the full scope of their practice.

Mandatory face-to-face consultations: From June 1, 2025, all nursing and midwifery prescribers must conduct in-person consultations before prescribing non-surgical cosmetic medicines, including anti-wrinkle injections and aesthetic emergency kit items.

In the UK, dermal fillers are classified as Class III medical devices, which are considered high-risk, according to the MHRA (Medicines and Healthcare products Regulatory Agency). This classification means that dermal fillers, even those without a medical purpose, are subject to stricter regulations under the Medical Device Regulations. The MHRA is responsible for regulating medical devices, including dermal fillers, within the UK. 

Here\’s a more detailed explanation:

  • Class III:This is the highest risk classification for medical devices, indicating that they require the most stringent regulatory oversight. 
  • MHRA\’s Role:The MHRA is the UK\’s regulatory body for medical devices, ensuring they meet safety and performance standards. 
  • Dermal Fillers:Dermal fillers, including those used for cosmetic purposes, are now classified as Class III devices because of their potential risks and the need for robust regulation. 
  • Regulation Changes:The UK is aligning its regulations with international standards, including those of the EU, to ensure a high level of safety for dermal fillers. 
  • Manufacturer Responsibilities:Manufacturers of dermal fillers must comply with the Medical Device Regulations, including providing technical documentation, clinical evaluations, and quality management systems. 
  • Beyond Medical Purpose:Even dermal fillers marketed for aesthetic or non-medical purposes are subject to the same Class III classification and regulations. 

Safety Implications of Current Regulations

The lack of stringent regulations for dermal fillers has led to several safety concerns:

1. Risk of Unqualified Practitioners

Unlike Botox, which requires a prescription from a qualified medical professional, anyone can legally administer dermal fillers. This has resulted in a proliferation of unqualified practitioners offering treatments with limited or no medical training.

2. Inadequate Knowledge of Facial Anatomy

Administering dermal fillers requires a thorough understanding of facial anatomy to avoid complications such as:

  • Vascular Occlusion: Blockage of blood vessels, which can lead to tissue death.
  • Nerve Damage: Improper injection can cause temporary or permanent nerve injury.
  • Asymmetry: Lack of precision can result in uneven results.

3. Poor Infection Control

Non-clinical settings may not adhere to strict hygiene standards, increasing the risk of infections and complications.

4. Difficulty Managing Complications

Reactions such as allergic responses, filler migration, or vascular compromise require prompt medical intervention. Non-medical practitioners may lack the skills and resources to handle these emergencies.

5. Misleading Advertising

Unregulated practitioners often use social media to promote treatments, sometimes exaggerating results or failing to disclose risks.

  • Cheap, unlicensed products
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