United Kingdom

The UK will strengthen the regulation of medical devices to protect patients

  • MHRA to reform medical device regulation to improve patient health և Encourage innovation
  • The UK is taking the opportunity to leave the EU to push for new legislation that will further improve people’s health.
  • To indicate that the products meet the world’s leading standards, they will bear the UKCA mark

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

Following the UK’s exit from the European Union (EU), the Drugs Regulatory Agency (MHRA) has a unique opportunity to improve the way in which medical devices are regulated և in vitro diagnostic medical devices (IVD).

The reform package will cover medical devices such as hearing aids, X-ray machines և insulin pumps; new technologies such as smartphone applications ական artificial intelligence (AI); as well as certain cosmetic products, such as skin fillers.

New events include:

  • Strengthen the MHRA’s mandate to act to keep patients safe – Give the public և greater patient guarantees for the operation of the highest risk medical devices և safety, such as those to be installed.
  • Increase the scope of regulation արձագ to respond to the needs of the public – Improve existing systems to better protect users of medical devices և certain cosmetic products և Provide greater safeguards for their work: safety.
  • Referring to health inequalities, mitigating inequalities found during the development and use of medical devices. The government has begun reviewing possible equity issues in the design of medical devices և to address health inequalities կ will be updated in a timely manner.
  • Making the UK an Innovation Center լավագույն The Best Place to Develop Innovative Medical Devices – Ensure that the new regulatory framework encourages responsible innovation so that UK patients can better use the most advanced medical devices to meet their needs.
  • Setting world leading standards ում Creating a new UKCA brand. Transformation of the new certification stamp, replacement of the CE mark with a trusted trademark, which means the world standards of safety, health and environmental protection, have been preserved for the production of medical devices. This in turn will boost the MHRA’s global reputation and growing partnership with other regulators

Sajid Javid, Secretary of Health and Social Care, says:

Now that we are out of the EU, these new changes will allow innovation to develop և to ensure that patients in the UK are among the first to benefit from technological advances.

We can now implement the strongest safety devices in the world for medical devices to protect patients.

MHRA Chief Executive Officer Dr. John Raine says:

As a regulator, our priority is to protect patients և the public և to facilitate և to speed up patients’ access to the medical equipment they need և to treatments.

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

We all know the importance of medical devices in our daily lives, ներդր your contribution has been invaluable in helping us shape future regulations և ensure patient safety and accessibility.

The regulations will be in line with emerging technologies, such as software AI artificial intelligence (AI), which are increasingly used in areas such as screening and diagnosis, as well as the management of chronic diseases and the development of new treatments. The new measures will ensure that such innovations meet the same sustainable standards as medical devices, while protecting patient safety while encouraging innovation to ensure that UK patients are among the first to have access to advanced healthcare.

Today’s announcement follows a consultation on the future regulation of medical devices, during which the MHRA sought feedback on a wide range of regulatory issues, from clinical research requirements to how devices are evaluated before they hit the market, to importers, and more. Distributors’ responsibilities և Post-market security monitoring թափ Transparency համար To increase the role of patients.

This is an ambitious, transformative reform program, և MHRA will ensure that legislative changes to the system meet the needs of industry և healthcare.

Work will continue և involvement with industry և stakeholders while improving legislation և making changes.

The MHRA will gradually introduce new requirements through transitional arrangements so that the industry has enough time to adapt to change.

Notes to editors:

  1. Medicines և Health Products Regulatory Agency (MHRA) is responsible for regulating all medicines և medical devices in the UK, ensuring that they work, are acceptable and safe. All our work is based on sound, fact-based judgments to ensure that the benefits justify any risk.
  2. MHRA is an executive agency of the Department of Health and Social Welfare.
  3. The government has introduced a bill to amend the Protocol establishing a dual regulatory regime in Northern Ireland. Once the bill becomes law, it will mean that businesses can choose between UK or EU standards by removing barriers to selling UK-compliant goods in Northern Ireland, reducing cost-cutting processes, and disrupting business.
  4. Under the current approach of the Northern Ireland Protocol, EU rules on medical devices և IVDs continue to apply in Northern Ireland. The EU Medical Devices Regulation (2017/745) (EU MDR) entered into force in Northern Ireland on 26 May 2021, and the In Vitro Diagnostic Devices Regulation (2017/746) (EU IVDR) entered into force on 20 May 2022. From 26. MDR և EU IVDR are not used in the UK.
  5. For more information on government reviews of possible bias in medical devices, visit: https://www.gov.uk/government/news/review-launched-into-the-health-impact-of-potential-bias-in-medical-devices

The UK will strengthen the regulation of medical devices to protect patients

SourceThe UK will strengthen the regulation of medical devices to protect patients

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