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UK Regulatory Update Challenges Are Affecting Potential Medical Device Supply: What You Need to Know!
- by Shital
- on August 8, 2024
The process of specialised translations of medical technology from academia to clinical settings has always faced various challenges, including inadequate regulation understanding and lack of centralised support.
However, in recent years, many UK medical institutes have spent on quality assurance teams and regulatory expertise to bridge this gap. Despite these efforts, new medical device regulations in the United Kingdom and European Union continue to become more strict. Therefore, it is impacting the availability of medical devices for clinical use.
Impact of Stringent Regulations:
The UK Notified Bodies and Approved Bodies that audit manufacturers against regulations are facing an increased burden due to regulatory changes; the number of these bodies has also decreased. As a result, MedTech innovators tend to seek FDA approval in the United States to gain market access. Therefore, it causes a reduction in medical devices available for clinical use in the UK.
A case study on virtual reality surgical planning tools developed at King’s highlights self-certification because of the lack of UK Approved Body involvement. It reduces the potential benefits for UK clinicians and patients.
MHRA Update:
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently conducted a public consultation on 16 September 2021, MHRA published on proposed changes to the regulatory framework for medical devices in the UK.
The government response was published on 26 June 2022, and a roadmap outlining future regulatory frameworks was published.
The UK has confirmed that its future Medical Device Regulations will be founded on five “pillars.”
- Empowering the MHRA to safeguard patients effectively.
- Prioritising innovation in the UK, especially in the domain of medical device development and introduction.
- Focusing on health equity and combating biases throughout the entire process of medical device production.
- Supporting businesses by tailoring regulatory requirements to align with both EU and global standards; and
- Creating top-tier standards – Establishing the UKCA mark as a global standard-bearer.
The MHRA is now drafting Statutory Instruments (SIs) for the regulation of medical devices in the UK, with the draft text publication anticipated by the World Trade Organization towards the end of 2024. It will be debated in parliament before it takes effect in 2025.
The primary objectives of the new UK regulatory updates are to improve patient safety, align with international best practices, and promote the UK as a favourable market for MedTech companies.
Although the UK is taking considerable steps to improve patient safety and align with international best practices. However, the stringent regulatory requirements are leading to challenges in the availability of medical devices for UK clinicians and patients.
Exploring the Scope of Regulatory Changes in the UK for Medical Devices!
These medical device regulations in the UK are undergoing a paradigm shift with proposed amendments that seek to redefine the scope of regulations and enhance the safety and efficacy of medical devices.
Let’s have a look at the key changes and implications brought about by the upcoming regulations.
Extending the Scope:
The amendment of new UK Regulations plans to broaden the definitions of medical devices to align with international standards.
Non-medical products with claim-level features and a similar risk profile, such as injectable dermal fillers, tattoo and concentrated beams used in hair removal lasers, and coloured contact lenses, will now fall under the purview of these regulations.
This expansion requires the registration of such products with the Medicines and Healthcare Products Regulatory Agency (MHRA).
A significant area of focus is the introduction of a globally harmonised medical device identification and coding system. This system aims to ensure the unambiguous identification of specific devices in the UK market by assigning a Unique Device Identifier (UDI).
Additionally, a registration database for medical devices will be established to enhance traceability and monitoring.
Changes to Definitions of General Medical Devices:
The reformed regulation will update the definition of general medical devices to encompass different products. It ranges from those used for cleaning and disinfection to devices supporting conception and aiding in the pathological and treatment processes.
The concept of ‘intended purpose’ will be clarified to minimize misunderstandings with manufacturers, setting clear objectives that are easily understood by users.
MHRA Future Roadmap:
The MHRA’s roadmap for 2024 outlines the trajectory for future reforms, that drawing on insights from the challenges faced during the implementation of EU regulations. Key areas of diversity from the EU framework include adopting the Global Medical Devices Nomenclature (GDMN), emphasising stringent pre-market requirements for implantable devices, and introducing specific regulations for Software as Medical Device (SaMD).
The roadmap aims to provide clarity and opportunities for medical device providers and the industry as a whole.
Medical device manufacturing & supply companies should always keep a few points to remember the detailed regulations and guidance in place.
- Conduct a thorough review of your product portfolio to understand the implications of the UK’s future Medical Device Regulations on device classification.
- Refer to the response document to the consultation for guidance on the upcoming changes.
- Assess whether your product might now fall under the scope of the regulations and ensure it meets the more stringent requirements, especially for borderline and aesthetic products.
- Plan for conformity assessments, as there is currently a limited number of UK-approved bodies and long lead times.
- Establish an appropriate Quality Management System (QMS) aligned with EU regulations and ISO 13485.
- Have at least one qualified person with regulatory experience in your organisation to meet future regulatory requirements.
- Ensure your post-market surveillance practices align with the strengthened requirements outlined in the UK’s future Medical Device Regulations.
- Build strong relationships with the MHRA and conformity assessment bodies to be proactive in responding to future regulatory changes.
- Consider harmonising EU rules and requirements with the UK regulations to minimise differing risk profiles across regions.
As the UK regulatory landscape for medical devices transforms, stakeholders must stay informed and adapt to the evolving requirements. These regulatory changes hold the promise of enhancing patient safety, fostering innovation, and ensuring the availability of high-quality medical devices in the UK market.
Euronoxx Medical Group Ltd is now embracing these changes, as the industry can navigate the shifting regulatory landscape and contribute to the advancement of healthcare technologies for the benefit of patients and clinicians alike.
We keep up-to-date on the MHRA regulatory updates and the impact they may have on MedTech innovation to ensure that patients in the UK continue to have access to the newest technology.
