On 19 August 2021, the Regulatory Horizons Council (the “RHC”) published a report setting out recommendations for reforming the regulation of medical devices in the UK (the “Report”)1. The RHC is an independent expert committee which provides the government with impartial, expert advice on regulatory reform of the medical sector in the United Kingdom.
This article summarises a number of key recommendations from the Report.
Background to the Report
The Report is set against a backdrop of a number of key challenges currently faced by the sector:
- Brexit: The UK’s departure from the European Union presents challenges, but also represents an opportunity to establish a new regulatory framework for the UK. The Report recommends amending the UK Medical Devices Regulations 2002 as a matter of priority.
- EU legislation in the healthcare sector: The EU Medical Device Regulations (2017/745) applied from 21 May 2020 and the in vitro Diagnostic Medical Device Regulations (2017/746) applied from 21 May 2021. The Report highlights these new developments as key drivers for the UK to update its own regulatory framework to bring it in line with other jurisdictions.
- COVID-19: The Report states that the ongoing COVID-19 pandemic has highlighted the importance of medical devices (such as personal protective equipment and in vitro diagnostic tests for the virus) and their relevance in preparing for any future pandemic.
According to the Report, the UK life sciences sector employs 256,100 people, and generates annual turnover of £80.7 billion. In order to allow the industry to continue to develop and thrive, the Report makes 11 recommendations for the regulation of medical devices in the UK. We have summarised some of the key recommendations below.
1. Regulation of medical devices to be patient-focused
The RHC puts the patient at the centre of medical device regulation. This recommendation requires patients to be engaged at all stages of the design pathway of a medical device, through increased co-operation with the Medicines and Healthcare products Regulatory Agency (the “MHRA”).
This supports the view outlined in the Independent Medicines and Medical Devices Safety Review (“IMMDS”) by Baroness Cumberlege in 20202, which criticised the harm caused by hormone pregnancy tests, the anti-epileptic drug sodium valproate and surgical mesh procedures. Greater patient engagement is likely to reduce the number of devices that pass standardised tests, but go on to cause patient harm once on the market due to lack of patient consultation.
2. Increase in number of Approval Bodies and UK Conformity Assessed certification (“UKCA”)
By 1 July 2023, all medical devices will need a UKCA mark to access the market. In order to avoid bottlenecks in the approval of devices, the RHC recommends providing support to Approval Bodies to enable them to meet the increased volume of UKCA certification applications. These measures would also aim to avoid a sharp peak of demand preceding the 1 July 2023 deadline, leading to further delays.
3. UK as global centre for regulatory science and training of regulatory professionals with expertise in regulation technology
The Report sets out the need for the UK to invest in training and regulatory science and innovation to support the rapidly expanding medical devices sector and the loss of expertise following the UK’s departure from the EU. Investing in this area would provide an increase of the pool of UK experts needed by ABs and in the industry overall.
4. Regulatory innovation to attract inward investment and growth
The Report recommends amendment of the existing UK legislation to put in place an “innovation friendly regulatory framework for medical devices”. One of the Report’s overarching themes is regulatory independence (e.g. from the EU) and it highlights the need for regulation that provides for new innovation in the industry, such as software and artificial intelligence. This would promote the UK’s status as a leader in building efficient regulatory systems for medical devices and medicines.
5. Developing a UK patient safety database
The RHC recommends the creation of a MHRA-led patient safety database that contains “adverse incidents, medicines, medical devices, blood and counterfeit products under the established Yellow Card scheme to ensure patient safety”. If created, the database could provide near-instant feedback, and automatically alert regulators of potential harms. This supports a similar recommendation from the IMMDS, which outlined that medical failures could be prevented in the future with inclusion of “adverse event reporting and medical device regulation”.
The Report also outlines legislation requiring devices to have a unique device identifier (UDI) to be included in patient’s health records and the patient safety database. This would provide for efficient identification of devices that potentially cause harm to the individual, and the ability to contact other patients with the device that might be susceptible to the same harm.
6. Fast-track evaluation of new in vitro diagnostics
The Report highlights the opportunity to consolidate the lessons learned during the COVID-19 pandemic, to inform future regulation of diagnostic testing. The Report suggests the use of Target Product Profiles where “the desirable characteristics and minimally acceptable specifications of a product that is needed to address a well-defined clinical problem is pre-specified”. Incorporating this guidance into the development of in vitro diagnostics would ensure accelerated development and streamlined regulatory routes to match the speed of infections.
The Report, combined with the IMMDS report by Baroness Cumberlege, highlights the acute need for new regulation of medical devices. On 21 July 2021, the government issued a response to the IMMDS3, accepting that the system failed to put patients at the centre of their care. Implementing the recommendations in both reports will ensure the UK’s regulatory framework can continue to facilitate the continuing growth of the UK’s life sciences sector.