United Kingdom

The long-awaited post market surveillance regulation for medical devices on the Great Britain market will come into force on 16 June.

The UK market has become tougher for smaller innovators, says Andy Mears, CEO of Deltex Medical, which plans to launch a new iteration of its minimally invasive ultrasound-based technology, the oesophageal Doppler monitor. He explained how market access challenges have steepened.

Partners Fresenius and Formycon have racked up another pair of approvals for their Otulfi ustekinumab biosimilar rival to Stelara, this time in the UK and Canada.

As efforts to improve diversity in clinical trials gain momentum globally, regulators in the UK, the EU, Canada, Australia and Japan were asked about their efforts to support representative enrolment. 

Greater reliance on point-of-care testing ticks the patient-centricity box of UK’s proposed elective care reform. But quality oversight from pathology professionals is vital to ensure that the safety and reliability boxes are also ticked, says the Institute of Biomedical Science.

UK prices for gabapentin almost trebled in December, according to the latest figures from WaveData.

Aurobindo’s biosimilars business is continuing to gain momentum, with a UK approval for bevacizumab in hand and further European nods expected.

The UK government kicks off a big year for National Health Service reform with a plan for 17 new or expanded surgical hubs by June and greater reliance on Community Diagnostic Centres.

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb brings highlights from Deloitte’s 2025 Life Sciences Outlook Report with medtech leaders’ forecasting significant investments in AI/GenAI. Brian Bossetta talks about the US FDA’s newly formed Digital Health Advisory Committee. Elizabeth Orr highlights the pros and cons of penetration testing for cybersecurity and talks about the US FDA’s final guidance on pre-determined change control plans. Natasha Barrow highlights UK MHRA's AI Airlock Pilot program and MANIFEST.

We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.