The British Medicines and Healthcare products Regulatory Agency published comprehensive guidance to detail the new post-market surveillance regulations going into effect on 16 June 2025. Evnia has summarised them in one, easy-to-print document!
Read and Download the document here : MHRA’s PMS requirements per device class
📢The guidance applies to medical devices (active implantables included) and in-vitro diagnostics in Great Britain (England, Wales, and Scotland). Products sold in Northern Ireland continue to follow MDR and VDR PMS requirements.
The British Agency has adopted a risk-based approach, whose key elements are enhanced data collection, shorter timelines for reporting serious incidents and summary reporting, and more explicit obligations for mitigating and communicating risks to the public.
Remember
Evnia offers UK representation services! Our UK Responsible Person operational branch is ready to provide services to manufacturers located outside the UK, who are looking to place a medical device or an in-vitro diagnostic on the Great Britain market
If you are in search of a qualified UK representative with extensive technical experience, do not hesitate to contact us.
Read more
