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June 27, 2022

UK MHRA unveils new plans to strengthen medical devices’ regulation

The new measures will include addressing disparities and mitigating identified inequities in the use of medical devices.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced new plans to improve patient safety by strengthening the regulation of medical devices.

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Following the UK’s exit from the European Union (EU), the MHRA had the opportunity to improve the regulation of medical devices and in vitro diagnostic medical devices (IVDs) in the country.

The new measures include providing assurance to the public and patients regarding the performance and safety of the highest-risk medical devices, including those that need to be implanted.

They also include enhancing systems that are already on the market to better protect users and provide greater assurance of safety and performance.

Additionally, MHRA plans to address disparities and mitigate identified inequities in the development and use of medical devices.

To tackle health inequalities, a review of the issues in the design and use of medical devices has been launched by the UK Government.

Furthermore, a new stamp of certification will be introduced to replace the CE mark.

The regulatory agency noted that the package of reforms will be applicable for medical devices such as insulin pumps, x-ray machines, hearing aids, new technologies, and certain cosmetic products, including dermal fillers.

MHRA chief executive Dr June Raine said: “As a regulator, our priority is to protect patients and the public and make it easier and quicker for patients to access the medical devices and treatments they need.”

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Free Report
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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

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