First Major Overhaul of Medical Device Regulation Comes Into Force Across Great Britain

Delivering a shot in the arm for UK medical device manufacturers

Ireland is home to a buoyant medical sector. Accommodating 14 of the top 15 medtech companies in the world, it is an attractive country for tech investment. While the UK may not yet be a match for Ireland on the international stage, the UK medical devices sector supports a thriving manufacturing base, with over 3,000

New MHRA PMS Requirements Hit UK Medtech Industry - Data Intelligence

The MHRA’s new post-market surveillance requirements for medical device manufacturers with products on the UK market are intended to enhance patient safety and communications around any issues. Image credit: Dave Hoeek via Shutterstock. New regulations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) around post-market surveillance (PMS) requirements for medical devices have come into effect. An amendment to the MHRA’s UK…

First major overhaul of medical device regulation comes into force across Great Britain

New Post-Market Surveillance (PMS) regulations have taken effect across Great Britain, requiring medical device manufacturers to proactively monitor the safety and performance of their products once on the market.

MHRA regulations enter into force requiring manufacturers to “actively monitor” safety and performance of medical devices – HTN Health Tech News

Regulations from the Medicines and Healthcare products Regulatory Agency (MHRA) have entered into force, requiring manufacturers to “actively monitor” the safety and performance of medical devices once on the market. The post-market surveillance regulations have been designed to help identify potential safety issues earlier and to enable faster responses to incidents and emerging risks, the agency shared. The Medical Devices (Post-Market Surveil…

Overhaul of medical device regulations in UK takes effect

The Medicines and Healthcare products Regulatory Agency’s (MHRA) has announced a major overhaul of how medical devices are regulated in Great Britain as part of a wider transformation of the UK’s medical device regulatory framework. Under the new Post-Market Surveillance (PMS) regulations device manufacturers are required to actively track the safety and performance of products already in use to help identify potential safety issues earlier. The…