The Medicines and Healthcare products Regulatory Agency (MHRA) has recently unveiled a significant overhaul of medical device regulations in Great Britain. This reform marks a pivotal shift in post-market surveillance practices and aligns with the UK’s efforts to enhance medical device safety post-Brexit. The updated regulations, set to take effect from June 16, 2025, will apply to a wide range of medical devices, from in vitro diagnostic tools to active implantable devices.
Manufacturers will now have increased responsibilities for monitoring device performance and safety in real-world settings, with a focus on proactive trend reporting to identify potential risks early. Practice managers in primary care and community settings must be aware of these changes and understand their implications on procurement, incident reporting, and safety monitoring of medical technologies. Staying informed and engaged with these developments is crucial for ensuring compliance and supporting the safe use of medical devices in healthcare settings.
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