How the New MHRA Roadmap Impacts Laser Aesthetic Clinics and the Importance of MHRA-Registered Devices

The regulatory landscape for laser devices is undoubtedly fast-moving. Here we summarise the latest developments and consider the impact of these for those in the sector, following on from the MHRA’s road map announcement on the 9th January.

The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled a roadmap for the future regulation of laser devices in the UK. These changes aim to enhance patient safety, ensure better post-market surveillance, and align with international standards. For laser aesthetic clinics, this roadmap marks a pivotal shift in operational standards and device compliance. Here’s what you need to know and why investing in MHRA-registered devices is more important than ever.

Key Changes and Their Impact on Aesthetic Clinics

1. Stricter Post-Market Surveillance Requirements Starting in 2025, clinics will face enhanced obligations to monitor and report on the safety and performance of their devices. This includes:
   • Maintaining detailed device usage records.
   • Reporting incidents promptly.
   • Conducting regular safety checks and reviews.

Impact: Clinics must implement robust tracking and reporting systems, ensuring they can provide evidence of compliance during inspections.

1. Revised Device Classifications Many laser devices, including those used for aesthetic treatments, will undergo reclassification. This change means some devices may now require higher levels of scrutiny and compliance.

Impact: Clinics will need to re-evaluate their existing equipment to ensure it meets updated classification and safety standards.

1. Introduction of Unique Device Identifiers (UDI) To improve traceability, the MHRA is introducing UDIs for devices. This system will help clinics track devices throughout their lifecycle.

Impact: Clinics must adopt inventory management systems capable of handling UDIs, ensuring efficient tracking and recall capabilities.

1. Extended Transitional Periods for CE Marked Devices While CE-marked devices will still be accepted during a transitional phase, the deadline for compliance is fast approaching:
   • General laser devices: 30 June 2028.
   • IVDs: 30 June 2030.

Impact: Clinics must plan for the eventual replacement or re-certification of CE-marked devices with UKCA-marked alternatives.

Why Choose MHRA-Registered Devices?

With the new roadmap emphasising safety, traceability, and compliance, investing in MHRA-registered devices is essential for laser aesthetic clinics. Here’s why:

1. Assured Compliance MHRA-registered devices meet rigorous UK standards, ensuring they comply with the new regulations. This reduces the risk of non-compliance penalties and operational disruptions.
2. Enhanced Patient Safety These devices are designed and certified to meet high safety and performance standards, fostering trust and confidence among clients.
3. Streamlined Audits and Inspections MHRA registration simplifies the audit process by providing clear evidence of compliance, saving clinics time and resources.
4. Future-Proof Investments MHRA-registered devices are already aligned with the UK’s regulatory trajectory, ensuring they remain valid and operational well beyond the transitional periods.

How Skintastic Supports Clinics in Adapting to the New Regulations

At Skintastic, we understand the challenges clinics face in navigating these regulatory changes. That’s why we offer:

• MHRA-Registered Devices Our range of laser devices comes with full MHRA registration, ensuring compliance and peace of mind.
• Training and Support We provide comprehensive training on device usage, post-market surveillance obligations, and record-keeping.
• Guidance on Compliance As an MHRA-registered UK Responsible Person, we stay updated on regulatory changes and offer expert advice to clinics.
• Engineer-Assisted Safety Checks Our devices are delivered with safety checks and calibration performed by qualified engineers, ensuring they meet the highest standards.

Take the Next Step Towards Compliance

The MHRA’s roadmap is a call to action for aesthetic clinics to prioritise safety and compliance. By investing in MHRA-registered devices and implementing the necessary systems, you can future-proof your clinic, enhance patient trust, and maintain your competitive edge.

Contact us today to learn more about our range of MHRA-registered devices and how we can help your clinic thrive under the new regulations.

The full report can be found on the UK.Gov site https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations

Watch the MHRA webinar here: