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