NEWS
New guidance on post- market surveillance for medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance for medical device manufacturers ahead of the new Post- market surveillance (PMS) regulation for medical devices in Great Britain (GB) which will come into force this summer. Key new requirements included
in the new guidance are enhanced data collection, shorter timelines for reporting serious incidents and summary reporting to enable the MHRA and manufacturers to identify safety issues earlier, as well as clearer obligations for risk mitigation and communication to protect patients and users.
Businesses are encouraged to start using the guidance straight away so that they understand their obligations and are ready to comply with the regulations when they take effect.
These new regulations are part of
wider regulatory reform and will introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across GB and provide certainty for manufacturers. The new legislation – which comes into force on 16 June 2025 – will
apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, in use in Great Britain. However, the PMS requirements vary based on the risk level posed by the device to patients. The guidance will provide additional detail on these requirements to support manufacturers with their PMS activities and help to ensure their devices continue to meet appropriate standards of safety and performance.
As businesses put the new guidance into use, feedback is welcomed, and the MHRA encourages this to be provided through trade associations, if businesses have one, who will be working closely with the MHRA to help identify and address where additional enhancements are needed. The MHRA will then update the guidance, if necessary, prior to the regulations coming into force. Laura Squire, MedTech Regulatory
Reform Lead and Chief Officer at the MHRA, said: “The new Post-market surveillance regulations will provide us with more safety information on medical devices in use in GB, allowing us to act swiftly when needed to reduce potential harm. This will enable not only the MHRA, but the whole health system, to better protect patients.”
POCT Innovators event – breaking through adoption barriers
The next POCT Innovators event, ‘Clinical Innovations EXPO – Breaking Through the Adoption Barriers’ will take place Thursday 15 May in Nottingham.
The tenth face-to-face event hosted by POCT Innovators and Thornhill Healthcare Events, it will focus on diagnostics, medical devices, digital and medicines; also hosting a varied exhibition of 40-plus stands at the Jubilee Hotel and Conference Centre, Nottingham.
Occupying the whole venue will allow
for a larger exhibition, as well as multiple break-out sessions alongside the plenary programme. The programme is currently being put together by regular organiser Tony Cambridge Lead Biomedical Scientist at University Hospitals Plymouth NHS Trust;
with the assistance of David Thorne, Director of Well Up North Primary Care Network, and ex-Chief Executive of Newcastle West CCG. Attendance is free to NHS and academic delegates with NHS or academic email addresses, but places are limited so book early. The Early Bird fee for Commercial delegates will be £199 +VAT which is available until 15 March 2025. Booking is now open via the website
www.poctinnovators.com.
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