New Proposals To Strengthen Medical Devices Regulation

A new report has highlighted the opportunities that the UK can take advantage of following its departure from the EU, and can now develop UK-specific regulation that puts patients first.

A UK.GOV press release states that the report, published by the Regulatory Horizons Council (RHC), sets out how the UK could strengthen the regulation of medical devices while learning lessons from the response to the coronavirus pandemic while boosting the UK’s world-leading life sciences sector.

The RHC is an independent committee that identifies the regulation needed to foster technological innovation and provide the government with impartial and expert advice on regulatory reform.

The new proposals set out how medical devices such as pacemakers or implantable defibrillators should be regulated to ensure that healthcare challenges can be tackled effectively, now and in the future.

The report suggests that the UK’s departure from the EU is an opportunity for the country to develop a UK-specific regulatory system that puts patients at the heart of the decision making process.

This could be by increasing patient representation on expert groups for advice on medical research and devices, or by providing evaluations of medical devices that are easily understandable.

It highlights the opportunities now available to the UK, not only to respond more quickly to new advances in technology but to work with like-minded countries in shaping international regulation.

Life Sciences Minister Nadhim Zahawi said: “Our life sciences industry is at forefront of global, modern regulation, as demonstrated by the speed and flexibility of the UK’s development and rollout of COVID vaccines.

“Today’s report supports our ambition to capitalise on the UK’s departure from the European Union and put in place streamlined regulation that will ensure we can bring to market safe and effective medical devices quickly, benefitting patients across the country.”

The report calls for lessons to be learnt from the UK’s COVID-19 response, including addressing delays in medical advice approval, and recommends that pandemic preparedness should now include fast-track evaluation of new in-vitro diagnostics and that the reporting of diagnostic tests be more transparent and standardised.

It also highlights opportunities for the UK to take a leading role in the development of international standards, particularly in sectors of importance such as AI, while exploring membership of international programmes such as the Medical Device Single Audit Program (MDSAP).

Also suggested is the use of medical devices as a template to help enable broader UK regulatory reform that improves patient safety and system efficiency by identifying areas where regulatory reform may attract inward investment and growth.

The publication of the report follows the launch of the government’s new Life Sciences Vision, published last month, which outlined ambitions for the sector over the next decade, including the Medicines and Healthcare products Regulatory Agency’s (MHRA) forthcoming consultation on a new regulatory framework for medical devices.

The Business Secretary Kwasi Kwarteng has written to the Regulatory Horizons Council welcoming the report, and the Department of Health and Social Care will respond in detail to its recommendations following the response to the forthcoming MHRA consultation.

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