The regulatory landscapes governing medical devices within the European Union (EU) and the United Kingdom (UK) have seen significant developments in recent years. With the EU's implementation of a Medical Devices Regulation and In-vitro Diagnostic Medical Device Regulation, and the UK's regulatory transition post-Brexit, industry stakeholders must now track separate and diverging requirements in these markets. This article provides an overview of the regulatory frameworks in both jurisdictions, highlighting key amendments, areas of divergence, and their implications for stakeholders.
European Union's regulatory landscape
Within the EU, medical devices are tightly regulated to ensure their safety and performance throughout their lifecycle, from pre-market evaluation to post-market surveillance.
The regulatory framework for medical devices prior to 2021 consisted of three directives:
- Directive 93/42/EEC, (the MDD)
- Directive 90/385/EEC (the AIMDD), and
- Directive 98/79/EC (the IVDD)
These Directives have been replaced by Regulation (EU) 2017/745 (the MDR), which covers both general and active implantable devices, and Regulation (EU) 2017/746 (the IVDR), which covers in vitro diagnostic medical devices, or IVDs. The reform followed a series of safety issues associated with certain medical devices, such as metal-on-metal hip implants and PIP breast implants.
United Kingdom's regulatory transition
The MDR was originally due to enter into application on 26 May 2020, but its date of application was postponed one year until 26 May 2021 due to the COVID-19 pandemic. The UK was a member of the EU when the MDR was drafted and had actively participated in the shaping of the regulations before Brexit. However, the delayed implementation of the EU MDR meant that it did not form part of the UK's "retained EU law" at the end of the Brexit transition period, which concluded on 31 December 2020. As a result, medical devices continue to be regulated in the UK using the Medical Devices Regulations 2002, SI 2002/618, which effectively implemented the previous EU MD Directives.
The Medicines and Healthcare Products Regulatory Agency (MHRA) launched a Delivery Plan in 2021 to reform the UK regime for medical devices. This plan covered all parts of medical device regulation from pre-market approval, supply of medical devices to the market and post-market monitoring. The UK government envisages that the new regime would run in parallel with current EU rules, which continue to apply in Northern Ireland. This is required in order to maintain the UK government’s approach on the movement of manufactured goods into Northern Ireland.
The MHRA released a roadmap in January 2024 outlining future reform, to provide clarity and outline opportunities for medical device providers and the industry as a whole. Many of the proposed amendments to the current UK regime outlined in the roadmap align with the MDR/IVDR. However, the MHRA aims to learn from the challenges faced during the implementation of the EU MDR regime in the EU, and possible areas of divergence include:
- Adopting the Global Medical Devices Nomenclature (GDMN) as medical device nomenclature for the UK system while the EU has adopted the European Medical Device Nomenclature (EDMN).
- Removing rarely used routes such as batch verification, product quality assurance and type-examination. Options to strengthen and clarify the conformity assessment requirements are also proposed.
- Adding obligation on economic operators to inform the MHRA of any issues affecting the supply of medical devices on the UK market.
- Specific regulation for software as medical device (SaMD) is proposed as a key area of divergence.
- On implantable devices: expanding the scope, introducing more stringent pre-market requirements, more controlled access and reducing the relevance of equivalence criteria. The UK Government has decided to maintain the existing scope.
- Expanded requirements for re-manufacturing of single-use devices.
MHRA Work Programme: Software and AI as a medical device
In conjunction with these reforms, the MHRA launched a consultation on the future regulation of medical devices in the UK. In particular, Chapter 10 of the consultation proposal provides the possible changes that would be specific to, or have implications for, SaMD.
These changes include, for example:
- Defining software
- Modifying the definition of ‘placing on the market’ to clarify when SaMD is deployed on websites, app stores and via other electronic means, and
- Defining specific requirements for AI as a Medical Device (AIaMD).
The intention of the MHRA’s work programme is that it will set a benchmark for the development of regulation for medical device software in the UK. The work packages aim to ensure that:
- The requirements for software and AI as a medical device provide a high degree of assurance that they are acceptably safe and function as intended, thereby protecting patients and the public.
- The requirements are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to show compliance, for instance, via the designation of standards.
- Friction is taken out of the market by working with key partners like the National Institute for Health and Care Excellence and NHSX to align, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK. The NHSX is a joint unit bringing together the Department of Health and Social Care, NHS England and NHS Improvement to drive digital transformation of care.
The MHRA’s work programme includes eleven work packages across two workstreams:
- Key reforms across the SaMD lifecycle, and
- Further challenges that AI can pose to medical device regulation.
It is anticipated that much of the reform required to meet the objectives in the work packages will be in the form of clarification-based guidance, standards, or processes rather than secondary legislation.
Some key elements of the eleven work packages are:
- Qualification - Ensure that medical device regulations are broad enough to capture relevant software and protect patients and the public.
- Classification - Ensure that classification rules can closely track the risk that SaMD poses, but also impose proportionate safety and performance requirements and incorporate enough flexibility to address novel devices.
- Pre-market – Ensure that SaMD is safe, effective and of requisite quality before being placed on the market, that any pre-market requirements are sufficiently clear and appropriate for SaMD, and that there are appropriate registration requirements for a robust post-market surveillance system.
- Post-market – Ensure a robust post-market surveillance system with a clear safety signal to efficiently deal with, and thoroughly capture, adverse SaMD incidents is in place. Ensure SaMD functions as intended via use of real-world evidence, maintains performance and clearly outlines change management requirements and processes.
- Cyber Secure Medical Devices - Articulate how cybersecurity issues can translate to SaMD safety issues and ensure this is adequately reflected in both SaMD pre-and post-market surveillance requirements. Cooperate with other relevant bodies, for example, the Connected Medical Devices Security Steering Group for consistency of approach.
- Mobile Health, and Apps - Collaborate across government via other work packages to ensure that the SaMD market provides further safety, effectiveness, and quality assurance.
Further announcements
More recently, the MHRA has also announced a suite of further initiatives designed to set the UK apart from the EU as a home for the development and commercialisation of innovative healthcare technologies. These initiatives include:
- AI Airlock: Announced in October, this regulatory sandbox aimed at understanding and mitigating risks associated with AIaMD prior to placing on the market will include four to six projects to test regulatory issues in clinical settings. The objective is to identify challenges and share findings to aid regulatory and funding efforts. MHRA emphasises collaboration and transparency, with no guarantee of regulatory conformity. Applications will open after a webinar in June 2024, with an associated pilot programme involving partners like Team AB and the NHS intended to ensure consistent regulatory interpretation.
- Impact of AI on regulation: The MHRA published a policy paper in April 2024 outlining the potential impact of AI on medical products regulation. The paper states that many low-risk AI products will be reclassified for greater scrutiny, enhancing user safety. The paper also outlined MHRA plans to use machine learning to streamline document assessments, allowing human experts to focus on critical evaluations.
- International recognition: The MHRA recently announced plans to incorporate approvals from third countries and MDSAP certificates alongside UKCA marking until June 2030. A Comparable Regulator Countries framework would tap into global regulatory expertise, including the FDA, EU member states, Health Canada, and the Australian TGA. Reliance on other regulators' assessments would provide for faster UK approvals, focusing MHRA resources on innovation. Different risk classifications and documentation formats would need to align with UK regulations, and operational details would be developed with industry input. Certain product categories would be excluded from this framework, transitional arrangements for UKCA marked devices would be developed and the regulatory status of products on the market in Northern Ireland would remain unaffected.
Comment
It is clear that the MHRA is seeking to position the UK as a leader in the regulation of high-tech healthcare products by establishing a streamlined yet robust regulatory framework. Once planned changes are eventually enacted, it will be interesting to see how, or if, the future regime on the regulation of this sector in the UK differs to that in the EU. While the EU and UK share common objectives of enhancing medical device safety and fostering innovation, disparities will now exist in their regulatory approaches. Key areas of divergence include naming conventions and standards, conformity assessment procedures, and specific regulations for AI-driven devices. However, both jurisdictions recognise the importance of transparency, patient safety, and regulatory collaboration in shaping the future of medical device regulation.
As the regulatory landscape continues to evolve, stakeholders must navigate the complexities of compliance and stay abreast of regulatory updates. Ultimately, a harmonised approach to medical device regulation, balancing innovation with safety, will benefit patients, healthcare providers, and industry stakeholders alike.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
