On 26 June 2022, the UK government published its response to the consultation on the future of medical devices regulation in the UK. The consultation ran between September and November 2021 (see further here). The outcome has been eagerly anticipated, not least by the industry keeping a weather eye on the looming summer 2023 UKCA mark transition date. The government received nearly 900 responses, and it seems confident in its mandate for the course it is setting, citing ‘strong support’ for measures to improve safety via regulatory oversight.
The response document runs to 155 pages and sets a clear direction of travel, although it does not provide all the answers some may have hoped for, with heavy lifting entrusted to future detailed guidance. The response’s overarching objective is ‘safeguarding public health,’ although the government says it has also listened and responded to concerns regarding availability of medical devices and the favourability of the UK as a place for innovation, with the aim of creating a ‘new balanced framework…that ambitiously yet pragmatically supports the UK’s MedTech industry.’
Secretary of State for Health and Social Care, Sajid Javid, talked of the government’s commitment to ‘cementing our status as a science superpower by making the UK the leading global hub for life sciences’ and said that the response ‘outlines policies that will help to achieve this.’
The response centres this ‘world-leading’ medical device regulatory framework around five pillars:
- Strengthening the MHRA’s power to act to ensure patient safety
- Fostering innovation
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles
- Proportionate regulation to support businesses through access routes building on synergies with EU and global standards
- Setting world-leading standards: building the UKCA mark as a ‘global exemplar’
Seven key themes from the response:
1. The overarching objective of safety is apparent, and the government’s clear intention is to regulate medical devices more stringently, both pre- and post- market. For example, through:
- increasing the accountability of economic operators, including manufacturers, importers and distributors (with supplementary guidance to clarify the roles and responsibilities of importers, distributors, and fulfilment service providers).
- requiring UK responsible persons to have a UK address and to be ‘legally liable’ for defective products ‘on the same basis as the manufacturer,’ though this will be ‘subject to further consideration on how this would operate in practice.’
- requiring manufacturers to implement measures (eg ‘sufficient financial coverage’) for providing ‘recompense to those impacted by adverse incidents…commensurate with the type of device, risk class and size of the company.’
- prohibiting misleading claims (eg regarding safety and performance).
- enhanced transparency and traceability requirements via increased information at the point of device registration and via introduction of Unique Device Identifiers.
- Clarification and strengthening of the requirements for manufacturers to implement a post-market surveillance system (further guidance to follow); and to report statistically significant incident trends.
2. The plan is not simply to align with EU MDR or other international requirements. While in some areas, there is a clear intention to align, (eg device classifications with ‘international best practice’), in other areas, the plans go further, eg to require stricter equivalence for clinical evaluation purposes than EU MDR (on an ‘entire equivalence’ basis) to ‘mitigate product creep’ – again with ‘clear and detailed guidance to follow.’
3. The government also intends to introduce alternative routes to market, including an ‘innovative MedTech route’ to market to support innovation – with ‘guidance to be published outlining further details.’
4. The concept of addressing health inequalities and bias is one of the five key pillars, with the government determined to ‘suppor[t] the identification of potential equity issues…arising from patient characteristics…and improv[e] standards to tackle these disparities.’ Dame Margaret Whitehead’s rapid review into addressing bias in UK medical devices (announced in November 2021, after the consultation opened) is ongoing (see further here). No concrete proposals appear in the response, although the MHRA is said to ‘recognis[e] the role of regulatory standards for equitable outcomes and will provide extended guidance on how manufacturers…can demonstrate…safety and efficacy of their products across diverse populations,’ indicating that we may expect results via guidance and standards rather than regulations.
5. With respect to the regulation of software as a medical device (SaMD) and AI as a medical device (AIaMD), change in this area is likely to be in the form of guidance rather than legislation. The government still intends to add a new definition of ‘software’ to the regulations but with supporting guidance to ‘ensure sufficient clarity.’ Further essential requirements to assure safety and performance of SaMD will be introduced considering themes such as data privacy, cyber security and confidentiality, and the intentions seems to be to align here in key respects with EU MDR and IVDR. The government clarifies that it sees AIaMD as a ‘subset of SaMD’ and does not intend to introduce specific requirements for AIaMD in legislation beyond those being considered for SaMD as this ‘would risk being overly prescriptive.’ The government will also create a novel pathway for software as a medical device, ‘addressing challenges ahead of our international peers.’
6. On the issue of environmental sustainability, the government will proceed with two of its four proposals: to broaden the circumstances where electronic labels and instructions for use can be used, and to require design and manufacture in a way that reduces the risks posed to public health by substances or particles that may be released from the device including wear debris, degradation of products and processing residues. This will be done via guidance on best practice rather than new regulatory requirements. The government will not implement proposals to require environmental and public health impact assessments, or to introduce waste management responsibilities into the medical device supply chain, though states these may be the subject of further consultation.
7. Transitional arrangements - a ‘stepwise approach’: the government still intends for the new regulations to come into force in 2023 but notes broad respondent support for a ‘stepwise transition’ and ‘phased’ approach to the new framework, and will allow additional time for CE marked products of up to three to five years.
- A significant amount of heavy lifting is left to future detailed guidance, so it is not yet possible to build up a clear picture of the future UK regime.
- In these circumstances and without detailed draft regulations, the extended transitional arrangements will be welcome to industry.
- There are some points of concern, and we will be watching closely the development of the provisions requiring manufacturers to have ‘measures in place to provide recompense’ to those ‘impacted by adverse incidents;’ and requirements for UK responsible persons to be ‘legally liable’ for defective products ‘on the same basis as manufacturers.’