Policy paper

Health Bill: medicines and medical devices regulatory reforms - fact sheet

Published 9 September 2026

Introduction

The Health Bill (‘the bill’) will help modernise the legislation that govern medicines and medical devices in the United Kingdom. Medicines and medical devices are regulated through a set of laws and regulations to ensure that medical products used by patients are safe and effective. They also set out how new medicines and medical devices can reach the people who need them.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK regulator for medicines, medical devices and blood components for transfusion. MHRA protects public health by assessing products before they reach the market, monitoring their safety, and acting when concerns arise. The bill will give MHRA and the government new tools to keep the regulatory framework up to date and operating effectively. This will help ensure that regulation continues to protect patients while supporting innovation and growth in the life sciences sector.

Background and bill objectives

The current legal framework for medicines and medical devices is complex and difficult to update. This can make it harder for businesses, particularly smaller companies, to understand what is required of them and to bring innovative products to market.

While the framework continues to protect public health, this complexity also means that the process for updating regulations can be slow. As a result, changes needed to respond to scientific developments, new technologies and evolving healthcare practice can take longer than is desirable. This can cause delays in innovative products becoming accessible, and put pressure on healthcare professionals, the NHS and industry where the legislation they work within has not kept pace with changes in the health landscape.

Current legislation also limits MHRA’s ability to share information efficiently with UK and international partners. In some cases, this can slow collaboration and make it harder to respond quickly to emerging issues affecting medicines and medical devices.

The bill will create a more flexible framework that means regulations can be updated more easily and information shared more effectively. This will help maintain high standards of patient safety while supporting access to innovation, improving collaboration across the health system and encouraging growth in the life sciences sector.

The bill will also establish the legislative foundation for a future medical device licensing regime, streamlining the medical device regulatory framework for innovative products. The new regime will support a more agile and innovation-friendly approach to regulation, making the UK a more attractive market for innovators, accelerate patient access to new technologies and maintain robust protections for public health.

The bill includes measures on:

• regulatory reform
• information sharing for medicines and medical devices
• powers to establish a future medical device licensing regime

Regulatory reform

Ambulatory references

Current legislation generally requires technical requirements to be written directly into regulations. Where legislation refers to an external document, which contains such technical requirements, it often refers only to a specific version of that document and does not automatically reflect later updates.

An ambulatory reference allows legislation to refer to an external document in a way that automatically reflects future updates to that document, without the need to amend the legislation itself.

The bill will allow greater use of ambulatory references in delegated legislation.

For medical devices, there is currently the power to make ambulatory references to international standards and agreements. This power will be extended to the following domestic documents:

• lists of British technical standards
• lists of countries covered by mutual recognition agreements
• lists of devices eligible for entry to the Great Britain (England, Scotland and Wales) market through international reliance routes

For medicines, the bill will introduce a power to make ambulatory references to international standards and agreements.

These changes will:

• help ensure the regulatory framework can better keep pace with advances in science, technology and clinical practice
• support timely access to innovative medicines and medical devices for patients
• provide greater clarity for industry

Proportionate consultation

At present, a public consultation is generally required for all regulatory changes, regardless of whether the change is a significant policy change or purely technical. The bill will allow a more proportionate approach for minor and technical changes, with the option to consult people and organisations as appropriate. This duty means that organisations and individuals with a significant interest in proposed changes will continue to have opportunities to contribute. This change will help ensure that regulations can be updated more quickly while maintaining appropriate stakeholder engagement. Significant policy changes will continue to be subject to a full public consultation.

Use of the negative procedure

Most changes to medicines and medical devices regulations currently require the draft affirmative parliamentary procedure. This means they must be debated and approved by both Houses of Parliament before they can come into force.

The bill will allow a limited category of minor, technical and administrative changes (including fee uplifts to recover costs) to be made using the negative procedure. This means that the changes can become law automatically without requiring a vote in Parliament. However, Parliament can still scrutinise the changes and can block them if either the House of Commons or the House of Lords objects within a set period, usually 40 sitting days. This procedure is more proportionate for the category of amendments within scope of the change. More significant policy changes will continue to require the draft affirmative procedure and parliamentary debates in both Houses of Parliament.

Impact of the changes

These reforms will make it easier to keep medicines and medical devices regulation up to date. They will support faster responses to scientific developments, technological innovation and changes in clinical practice, while maintaining appropriate consultation and parliamentary oversight.

Information sharing powers for medicines and medical devices

MHRA currently relies on individual information sharing agreements or memoranda of understanding with organisations before select information regarding medicines and medical devices, such as audit reports and safety reporting information, can be shared. While legislation provides some powers to share information about medicines and medical devices internationally, there are no equivalent powers to share information about medicines domestically. This can be time-consuming, burdensome for all parties and may slow collaboration.

The bill will provide updated powers to share select information about medicines and medical devices with relevant UK and international partners. The powers will make it easier to share information with organisations that have responsibilities relating to health, science or medical products. The powers also clarify the circumstances in which MHRA can share commercially sensitive information regarding medicines and medical devices, where such disclosure is appropriate (taking into account the public interest as well as the interests of persons to whom the information relates) and, where relevant, taking into account the overarching objective to safeguard public health.

Existing safeguards under the relevant data protection legislation will continue to apply when patient information is shared, and patient information may not be shared internationally without their consent.

Impact of the changes

These changes will improve collaboration between MHRA and UK and international health system partners, enhance information sharing to strengthen patient safety and public health protection. It will also support patient access to medicines and medical devices and help MHRA respond more effectively to emerging risks and opportunities, whilst maintaining appropriate safeguards in connection with information sharing.

Professor Jonathan Benger, CEO of the National Institute for Health and Care Excellence (NICE), said:

NICE welcomes these proposed amendments to the information sharing powers, which will help patients benefit more quickly from safe, effective and innovative medicines and health tech. By enabling appropriate information sharing between health system partners, the proposals support faster access to innovation while maintaining strong safeguards, protecting confidential regulatory processes and ensuring existing data protections continue to apply.

Medical device licensing regime

The current Great Britain medical devices framework is based on a system inherited from the European Union. Most medium and high-risk devices must be assessed by third party approved bodies before they can be placed on the market.

The bill will provide powers to establish a medical device licensing regime through future regulations. These powers could allow MHRA to directly assess and licence medical devices and certain regulated businesses, including manufacturers, importers and wholesalers.

A licensing model could provide greater flexibility by allowing regulatory requirements to be tailored through licence conditions. It could also support a more proportionate approach to the evidence needed for market access and simplify the wider regulatory framework. The powers would help support a sustainable domestic route for assessing medical devices, particularly as Great Britain develops international routes that may rely on assessments already carried out in other countries.

The bill does not itself establish a licensing regime and does not create new requirements for manufacturers, healthcare providers or patients. Any future licensing framework would be developed through further policy work, consultation, impact assessment and parliamentary scrutiny. The bill does not determine how licences would be granted, what licence conditions would apply, or what fees might be charged. These details would be set out separately in future regulations. However, the bill contains sufficient detail of the proposed framework underpinning such future regulations to give Parliament assurance of its parameters and set an appropriate balance between primary and secondary legislation.

Impact of the changes

For patients, these powers enable the development of a regulatory system that could provide earlier access to innovative medical technologies while maintaining appropriate safeguards for safety and performance. For industry, they provide a foundation for a more modern route to market in Great Britain and support innovation, investment and growth. For healthcare professionals, they support a regulatory framework that can respond more effectively to new technologies and changes in clinical practice while maintaining robust oversight of medical devices.