THE UK REGULATORY PATHWAY FOR MEDICAL DEVICES

Rosanne Joseph-Anthony offers a comprehensive guide

The aesthetic medicine and med tech sector has experienced significant progress with the development of innovative medical devices.However, with these innovations comes the need for strict regulatory compliance to ensure patient safety and treatment efficacy.

Since Brexit, the regulatory landscape for aesthetic medical devices in the UK has changed significantly. The Medicines and Healthcare products Regulatory Agency (MHRA) is now responsible for overseeing medical devices in Great Britain (England, Scotland, and Wales), while Northern Ireland remains aligned with EU Medical Device Regulation (MDR) 2017/745.

For aesthetic practitioners, clinic owners, and device manufacturers, understanding the UK’s regulatory framework is essential to ensure compliance, avoid legal risks, and maintain high standards in patient care.

THE UK REGULATORY FRAMEWORK FOR AESTHETIC MEDICAL DEVICES

Key legislation

Aesthetic medicine and medical devices, such as robotic hair transplantation equipment, dermal fillers, laser devices, skin-tightening machines, microneedling tools, and body contouring equipment, fall under the UK’s medical device regulations:

• Medical Devices Regulations 2002: This legislation continues to apply in Great Britain.

• UK Medical Devices Regulations (UK MDR) 2021: Updates post-Brexit to establish a UK-specific regulatory framework.

• EU MDR and IVDR (2017/745 & 2017/746): Applicable in Northern Ireland under the Northern Ireland Protocol.

The role of the MHRA

The MHRA plays a crucial role in ensuring the safety, quality, and efficacy of medical devices in the UK. Its responsibilities include:

• Reviewing device applications to determine market eligibility

• Granting UK Conformity Assessed (UKCA) certification for devices used in Great Britain

• Overseeing post-market surveillance to monitor adverse effects and safety concerns

• Inspecting clinics and distributors to enforce compliance with medical device laws

For practitioners and clinics, using only UKCA- or CE-marked devices ensures regulatory compliance and minimises legal risks.

For manufacturers seeking to market devices in the UK must adhere to MHRA guidelines and engage with UK approved bodies for conformity assessment where necessary.

Classification of medical devices in the UK

Aesthetic medical devices are categorised based on risk level, following a classification system similar to the EU MDR:

• Class I (low risk): Non-invasive devices such as bandages, stethoscopes.

• Class IIa (medium risk): Devices with moderate risk, including dental fillings and hearing aids.

• Class IIb (higher risk): More complex devices such as ventilators and infusion pumps.

• Class III (highest risk): Devices critical to sustaining life, such as pacemakers and implantable defibrillators.

In aesthetic medicine, many devices fall into class IIa and IIb, requiring strict regulatory oversight, especially for those used in invasive procedures.

In vitro diagnostic (IVD) devices have their own classification rules under UK regulations, ensuring appropriate oversight based on the intended use and risk profile.

THE UKCA MARKING PROCESS FOR AESTHETIC MEDICAL DEVICES

From January 1, 2021, the UKCA (UK Conformity Assessed) marking replaced the CE marking in Great Britain. However, CE-marked devices can still be sold in the UK until June 30, 2025, under transitional arrangements.

Steps to obtain UKCA certification in England and Wales

• Device classification: Determine whether the aesthetic device is class I, IIa, IIb, or III.

• Engage a UK-approved body: For Class IIa, IIb, and III devices, manufacturers must work with a UK-approved body for certification.

• Technical documentation: Provide evidence of the device’s safety, efficacy, and compliance with UK regulations.

• Declaration of conformity: Manufacturers must issue a statement confirming compliance with UK regulatory requirements.

• Apply for UKCA marking: Submit the application to the MHRA, and once approved, affix the UKCA mark to the device.

What about Northern Ireland?

Under the Northern Ireland protocol, medical devices follow EU rules:

• CE-marking remains mandatory.

• UK(NI) marking is required for devices assessed by a UK Approved Body, but this marking is not recognised in the EU.

Challenges facing aesthetic device manufacturers and clinics

The UK’s post-Brexit regulatory landscape has created significant challenges for medical device manufacturers and aesthetic clinics. As a result, some have chosen to withdraw their products from the UK market due to:

• Regulatory complexity: Compliance with both UK and EU regulations creates additional administrative burdens. The frequent updates and changes in UK regulations have made compliance complex and unpredictable

• UKCA marking requirements: The transition from CE marking to UKCA marking has introduced additional costs and administrative burdens

• Lack of mutual recognition with the EU: Without mutual recognition agreements, manufacturers must navigate separate regulatory pathways for the UK and EU markets

• Supply chain disruptions: Increased border checks and customs procedures have led to delays in importing medical devices.

• Limited UK-approved bodies: A shortage of UK-approved bodies to certify medical devices has slowed down approvals and market entry

• Rising compliance costs: The need to meet UK-specific regulatory requirements has increased costs, discouraging some manufacturers from maintaining a UK presence

• Uncertainty about future changes: Ongoing regulatory reforms create hesitancy among businesses regarding long-term investment in the UK

• Certification delays: A limited number of UK Approved Bodies has slowed the UKCA certification process

• Market viability issues: Some manufacturers find the UK market too small to justify the costs of dual certification

• Post-market surveillance: Stricter reporting requirements mean increased vigilance and administrative workload.

As a result, some aesthetic devices have been withdrawn from the UK market, affecting product availability for clinics and practitioners.

HOW ACCELLERATE CAN HELP CLINICS

Device selection and due diligence

• Ensuring clinics invest in UK MDR-compliant devices that align with medical and aesthetic needs

• Conducting clinical and commercial viability assessments before clinics adopt new technology.

Training and practitioner compliance

• Helping clinics train staff in safe and compliant device use

• Advising on CQC and MHRA regulations for aesthetic and medical treatments

• Ensuring practitioners meet licensing requirements for device operation.

Integration with clinic services

• Advising on best practices for incorporating new devices into existing treatment offerings

• Supporting marketing and patient education strategies to drive treatment adoption

• Helping with data integration to align new technology with patient management platforms like MedisynQ.

Why medical device regulations matter for end users

For healthcare professionals and clinic operators, compliance with UK medical device regulations is critical for:

• Ensuring patient safety: Regulated devices undergo rigorous assessment to verify their safety and efficacy

• Reducing liability risks: Using noncompliant devices can lead to legal and financial repercussions

• Maintaining high standards of care: Choosing UKCA- or CE-marked devices guarantees adherence to regulatory requirements.

End users should:

• Verify regulatory markings before purchasing medical devices

• Choose reputable suppliers that comply with UK and international standards

• Stay informed about regulatory updates to ensure continued compliance.

FUTURE DEVELOPMENTS IN UK MEDICAL DEVICE REGULATION

The UK is developing a new Medicines and Medical Devices Bill, which will further refine regulatory policies. The MHRA aims to:

• Align UK regulations with global standards

• Enhance post-market surveillance to improve patient safety

• Foster innovation while maintaining rigorous safety requirements

• Manufacturers should stay updated on these changes to ensure continued compliance and market access.

Strategic benefits of partnering with Accellerate

Accelerate provides tailored support to manufacturers, clinics, and healthcare innovators, ensuring a seamless journey from product development to market entry. Here’s how we can customise our expertise for your specific needs:

For medical device manufacturers Regulatory compliance and market access: We navigate complex MHRA, UKCA, and CE marking requirements, ensuring a smooth approval process.

• UK Responsible Person (UKRP) services: Acting as your official representative, we manage documentation, post-market surveillance, and compliance updates

• Clinical validation and evidence generation: We facilitate clinical studies, real-world evidence (RWE) collection, and regulatory submissions to strengthen market positioning

• Strategic partnerships and distribution: We connect you with key NHS stakeholders, private healthcare providers, and distributors to drive adoption.

For clinics and healthcare providers

• Technology implementation and digital transformation: We assist with software integrations, ensuring compliance with NHS and regulatory standards.

• Operational efficiency and risk mitigation: Our expertise in cybersecurity, patient data management, and AI-driven solutions minimises risk and enhances workflow.

• Reimbursement and funding strategies: We help clinics navigate NHS procurement, private insurance, and funding opportunities for new technologies.

• Brand differentiation and market positioning: With our network of KOLs and marketing expertise, we enhance your reputation and visibility in the MedTech and aesthetics space.

Navigating the UK regulatory pathway for medical devices requires a clear understanding of classification, UKCA marking, post-market obligations, and evolving regulatory requirements. By staying informed and working with trusted partners like Accellerate Limited, manufacturers can ensure smooth market entry while end users can make well-informed decisions when purchasing medical devices.

For further guidance, refer to official MHRA publications and industry updates on regulatory changes. https://accellerate.co.uk/