These measures demonstrate the UK’s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes.

The exciting and fast developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health systems. Applications of AI to be regulated as medical devices can range from screening, to diagnosis, to treatment, and to management of chronic conditions. Regulatory measures will be updated to further protect patient safety and take account of these technological advances.

The MHRA has developed an extensive work programme to inform regulatory changes including key reforms across the software as a medical device lifecycle, from qualification to classification, to requirements that apply pre and post-market. This programme will consider challenges and opportunities posed by AI as a medical device, ensuring these devices are appropriately evidenced and address issues of human interpretability (lack of transparency of AI) and adaptivity (retraining of AI models).

These bold reforms will ensure that patients and public are protected and provide manufacturers with clear guidance to interpret requirements as well as the tools to demonstrate conformity. The changes will transform medical device regulation as it applies to software and AI, providing a regulatory system that is robust and dynamic for the future.

Minister for Innovation Lord Bethell said:

While the UK remains a leading destination for cutting-edge healthcare, we are always searching for new and innovative ways we can improve the health and care system for NHS patients.

Software and artificial intelligence in medical devices offer the potential to transform people’s lives and these updated regulations will make a significant difference in the diagnosis and treatment of a variety of conditions.

I look forward to seeing the tangible impact these changes will have on improving patient safety and care for years to come.

MHRA Director of Devices Graeme Tunbridge said:

Today’s announcement of an exciting step change in the regulatory approach in this fast moving area underpins the MHRA’s commitment to support responsible innovation that champions patient safety. Reforms will build on wider changes to medical device regulation already underway. We have also today launched our public consultation on proposed legislative changes in the Consultation on the future regulation of medical devices in the United Kingdom and we are encouraging everyone with an interest in these products and the way they are regulated to contribute their views.

We will continue to evolve our regulations and guidance to respond to this fast-paced field and carry out further research into how best to manage the challenges posed by artificial intelligence as a medical device.

In addition to our overhaul of the regulations for AI and software as a medical device, today BEIS announced that the MHRA are recipients of a grant from the Regulatory Pioneers Fund.

The grant for £194,000 supports the MHRA’s drive to become a global leader in regulating this field by carrying out further research into how adaptive AI algorithms in medical devices ‘change’ and how to regulate their decisions.

The MHRA is supported in bringing forward this programme of change thanks to support from NHSX, partners such as NICE, and input from academic and industry partners.

New plans to capitalise on the freedoms from Brexit so that our rules and regulations best serve the UK national interest have been announced today by Minister of State at the Cabinet Office, Lord Frost.

Thousands of individual EU regulations automatically kept on the statute book after Brexit – known as Retained EU Law – will be scrutinised by the Government to ensure they are helping the UK to thrive as a modern, dynamic, independent country and foster innovation across the British economy. The review will aim to remove the ‘special status’ that EU retained law still enjoys in our legal framework and will determine how best to ensure that UK courts can no longer give undue precedence to EU-derived laws in future. This will be done while providing businesses and citizens with legal certainty and will continue the process of restoring the UK Parliament to its proper constitutional position.

Additionally, the Government is setting out a package of individual regulatory reforms to laws inherited while a member of the EU, building on recommendations recently submitted to Government by the Taskforce for Regulatory Reform, Innovation and Growth.

In the coming weeks, Secretaries of State across Whitehall will set out bold strategies and proposals for keeping the UK at the forefront of innovation and technology, including on:

• Artificial Intelligence to supercharge its place in the UK economy, to grow investment, support research and development, and boost the nation’s skills – setting the standards for other countries to follow.
• Transport to unleash the UK’s potential as a world leader in future technologies like autonomous maritime vessels, self-driving cars and drones by modernising outdated EU vehicle standards.
• Farming to reform the regulations around gene-edited organisms, which will enable more sustainable and efficient farming and help produce healthier and more nutritious food.

This follows the proposed reforms to create a pro-growth, trusted data rights regime, which is more proportionate and less burdensome than the EU’s GDPR rules.

The Government also plans to establish a new Commission through which the public will be able to identify additional opportunities for cutting or reforming red tape and bureaucracy. Any individual will be able to submit proposals. The Commission will then consider these ideas and make recommendations for change to the Government – but only if they go in the direction of reducing or eliminating regulation.

Minister of State at the Cabinet Office, Lord Frost, said:

From rules on data storage to the ability of businesses to develop new green technologies, overbearing regulations were often conceived and agreed in Brussels with little consideration of the UK national interest.

We now have the opportunity to do things differently and ensure that Brexit freedoms are used to help businesses and citizens get on and succeed.

Today’s announcement is just the beginning. The Government will go further and faster to create a competitive, high-standards regulatory environment which supports innovation and growth across the UK as we build back better from the pandemic

Further reforms announced today include:

Modernising our economy:

• Introducing digital driving licenses, test certificates and MOT processes to streamline the process for motorists.
• Creating digital certificates for millions of shareholdings to replace their paper counterparts, making life easier for people who own and trade shares.
• Legislating to put electronic trade documents on the same legal footing as paper documents, removing the need for wasteful paperwork and needless bureaucracy.

Supporting research and development:

• Overhauling our clinical trial frameworks to improve trial set up and patient recruitment, giving a major boost to the UK’s world-class R&D sector and getting patients access to new lifesaving medicines more quickly.
• Reforming medical devices regulations to foster the development of new and emerging devices, harnessing cutting edge technology, software and AI. This will ensure access to the world’s most innovative technologies for NHS patients while maintaining quality and safety.

Reducing bureaucratic interference:

• Permitting the voluntary printing of the Crown Stamp on pint glasses and reviewing the EU ban on markings and sales in imperial units and legislating in due course, none of which were possible within the EU.
• Today’s announcement follows the government’s ongoing consultation into reforming the UK’s regulatory framework, which will respond to other recommendations from the Taskforce for Regulatory Reform, Innovation and Growth.

A full list of individual regulatory reforms announced can be found here.

The haulage sector has been experiencing a shortage of HGV drivers worldwide for some time. The issue has been further exacerbated by the coronavirus pandemic as driver testing had to be suspended for much of last year, meaning the shortage increased further.

This country enjoys a robust and resilient supply chain. Nevertheless, there is no room for complacency and this government is determined to do what it can to mitigate the effects as far as is possible. It is therefore vital that we expedite legislation that will expand and accelerate testing – while at the same time acknowledging that the road haulage industry must play its part in improving recruitment and training by offering better pay and conditions.

The Department for Transport and other government departments have worked closely with the haulage sector considering a range of options to improve the number of HGV drivers. As part of these measures a consultation closed on 7 September on change to streamline the HGV driving licence regime and removing a separate trailer test for car drivers. The Driver and Vehicle Standards Agency has already taken administrative action to increase capacity and offer more practical HGV tests but more is needed.

The first of these measures will be addressed via a draft affirmative statutory instrument that will be laid before Parliament today (16 September 2021) and will mean that car drivers will no longer need to take another test to tow a trailer or caravan, freeing up some 30,000 test slots annually. This additional capacity can be used to reduce the backlog in HGV testing.

To make rapid progress on this, we are making use of the urgent procedure under paragraph 14(6) of Schedule 8 to the European Union (Withdrawal) Act 2018. I am of the opinion that, by reason of urgency, the requirements for the statutory instrument to be published in draft 28 days before it is laid, and for a scrutiny statement to be made before laying, should not apply.

Accelerating the legislation by forgoing the 28-day publication period will allow earlier laying of the legislation than would have otherwise been possible and strengthen the steps we have already taken to increase testing capacity and ease supply chain issues as quickly as possible.

Arrangements will be in place to ensure that the changes made by the legislation are operationally effective as soon as the legislation is in force.

Road safety continues to be of paramount importance. We will engage with training providers and insurers to test the response to this change and to explore how we can seek to ensure that any road safety concerns are addressed. We will also explore options for an industry-led accreditation that could offer a standardised testing approach if that would be welcomed by the market, insurers and consumers.