08/02/2022
Photo by Tim Cooper on Unsplash
The Medicines and Healthcare products Regulatory Agency (MHRA) announced its plans to strengthen regulations for medical devices within the United Kingdom (UK). After “Brexit”, the UK had the opportunity to update its drug and device regulations separately from the regulations they followed while part of the European Union. The plans include:
Creating the UKCA mark, similar to the EU’s CE mark
Increasing focus on innovation
Strengthening MHRA’s ability to assure medical device performance and safety
Enhancing systems in place to protect medical device patients
Addressing health inequalities and bias
The medical device regulatory framework follows the objective of the Medicine and Medical Devices Act 2021 to safeguard public health, as well as objectives to improve safety of medical devices, support the availability of medical devices across the UK, and maintain status as an agreeable location for medical device business.
What are your thoughts on MHRA’s plans? Have you or your studies been impacted by UK’s withdrawal from the EU?
-The Clinical Pathways Team
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