Leaving the European Union has provided a unique opportunity for the United Kingdom to improve
the medical device regulatory regime and exercise our new powers as a sovereign regulator, creating a world-leading regime that prioritises patient safety while supporting innovation within the UK MedTech sector. To deliver this ambition and gather views of patients, industry and the healthcare sector, the Government published a consultation on the future UK medical device regulations, “Consultation on the future regulation of medical devices in the United Kingdom”, which is available at:
https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom, on 16 September 2021. We received 900 responses and I am grateful to all those who have taken the time to respond to the consultation.
Officials at the Medicines and Healthcare products Regulatory Agency (MHRA) have analysed the consultation responses and have worked with officials within my Department and the Office of Life Sciences to develop the Government response. The response outlines changes that will support innovation within the UK’s life sciences sector and access to medical devices, for example through improving the regulation of novel and growing areas such as artificial intelligence and offering alternative routes to market. This will help to facilitate greater opportunities for small and medium enterprises to capture real world evidence to support the conformity assessment process with the proportionate regulatory oversight, an opportunity which has not existed previously.
The Government are committed to cementing our status as a science superpower by making the UK the leading global hub for life sciences, and the response to the public consultation outlines polices that will help to achieve this.
As part of this consultation, the MHRA received strong support for proposals that will improve patient safety and safeguard public health, for example, through modernising the scope and classification rules of medical devices to deliver improvements in the safety of all medical devices. It also raised points around identified inequities within clinical investigations. I appointed Dame Margaret Whitehead to conduct a review into the potential issues related to equity in the design and use of medical devices and I am pleased that the MHRA will look to address these points within the regulations and supplementary guidance to support this review.
The new transitional measures outlined in the response will be implemented to support continued access to safe medical devices to UK patients, whilst providing time for industry and the healthcare sector to prepare for the transition. In fact, the UK Government are committed to building the UK Conformity Assessed (UKCA) marking as a global exemplar, and it is vital that the necessary building blocks are in place to ensure that the UK market remains an attractive and favourable place to innovate and do business for the benefit of patients and carers. A phased transition into the new regime is critical to its success.
The Government’s response to the consultation will be published on gov.uk today and I will deposit a copy of the response in the Libraries of both Houses.
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