UK tightens medical device regulations to protect patients

  • MHRA to reform medical device regulations to improve patient health and encourage innovation
  • The UK is seizing the opportunities offered by its exit from the EU to introduce new legislation that goes even further in improving the health of citizens
  • To signify that products meet these global standards, they will carry the UKCA mark.

New plans to strengthen the regulation of medical devices to improve patient safety and encourage innovation have been published.

Following the UK’s exit from the European Union (EU), the Medicines and Healthcare Products Regulatory Agency (MHRA) has a unique opportunity to improve the regulation of medical devices and diagnostic medical devices in vitro (IVD) in the UK.

The reform package will apply to medical devices such as hearing aids, x-ray machines and insulin pumps; new technologies such as smartphone apps and artificial intelligence (AI); as well as certain cosmetic products such as dermal fillers.

The new measures include:

  • Strengthen the powers of action of the MHRA to ensure patient safety – Giving the public and patients greater assurance about the performance and safety of the most risky medical devices, such as those that need to be implanted.
  • Increase the scope and breadth of regulation to meet the needs of the public – Improve the systems already in place to better protect users of medical devices and certain cosmetic products, and provide better assurance of their performance and safety.
  • Address health disparities and mitigate inequities identified throughout the development and use of medical devices – Mitigate inequities in medical devices, ensuring they work as intended for diverse populations. The government has launched a review of potential equity issues in the design and use of medical devices to address health inequalities and will update it in due course.
  • Make the UK a hub of innovation and the best place to develop and introduce innovative medical devices – Ensure the new regulatory framework encourages responsible innovation so that patients in the UK are better able to access the most advanced medical devices to meet their needs.
  • Setting global standards and creating the new UKCA mark – Turning a new certification stamp, replacing the CE mark, into a trusted mark that signifies that global safety, health and environmental protection standards have been met for medical device products. This will in turn enhance the MHRA’s global reputation and growth in partnerships with other regulators

Health and Social Care Secretary Sajid Javid says:

Now that we have left the EU, these new changes will allow innovation to thrive and ensure that UK patients are among the first to benefit from technological advances.

We are now able to introduce some of the world’s most robust safety measures for medical devices to ensure patient protection.

Dr June Raine, Chief Executive of the MHRA, says:

As a regulator, our priority is to protect patients and the public and to make it easier and faster for patients to access the medical devices and treatments they need.

We would like to thank everyone who shared their views through this consultation, including patients, industry and the healthcare sector.

We all know the importance of medical devices in our daily lives and your input has been invaluable in helping us shape future regulations and ensure continued patient safety and access.

Regulation will keep pace with new and emerging technologies, for example software and artificial intelligence (AI) which are increasingly used in areas such as screening and diagnosis, as well as chronic disease management and development of new treatments. The new measures will ensure that innovations such as these are held to the same high standards as medical devices, protecting patient safety while encouraging innovation to ensure UK patients are among the first to access healthcare peak.

Today’s announcement follows a consultation on future regulation of medical devices where the MHRA sought views on a wide range of regulatory issues – from requirements to conduct clinical investigations, to from how devices are assessed before they are put on the market, through to importer and distributor obligations and post-market safety surveillance to increase transparency and the role of patients.

This is an ambitious and transformational reform program and the MHRA will ensure that legislative changes to the system meet the needs of industry and the healthcare sector.

There will be continued work and engagement with industry and stakeholders while refining legislation and implementing changes.

The MHRA will gradually incorporate the new requirements with transitional arrangements, to give the industry enough time to adjust to the change.

Notes to Editors

  1. The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK ensuring that they work and are of acceptable safety. All of our work is backed by sound, evidence-based judgments to ensure that the benefits justify all the risks.
  2. The MHRA is an executive agency of the Department of Health and Social Care.
  3. The government has introduced legislation to amend the protocol to establish a dual regulation regime in Northern Ireland. Once the bill becomes law, it would mean businesses could choose between meeting UK or EU standards – removing barriers to selling products made to UK standards in Northern Ireland and reducing processes that drive up costs and discourage business.
  4. Under the current Northern Ireland Protocol approach, EU rules on medical devices and IVDs continue to apply in Northern Ireland. The EU Medical Devices Regulation (2017/745) (EU MDR) therefore entered into force in Northern Ireland on 26 May 2021 and the In Vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) came into force on 26 May 2022. EU MDR and EU IVDR do not apply in Britain.
  5. For more information on the government’s review of potential biases in medical devices visit: https://www.gov.uk/government/news/review-launched-into-the-health-impact-of- potential-bias-in-Medical Equipment

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