The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals ...

In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in ...

The overall aim of the MHRA's proposals are to reduce duplicative costs for device manufacturers and hasten market access. Image credit: Dave Hoeek via Shutterstock.com. · Medical Device Network · ...

Our mission is to ensure that patients have access to the high-quality, safe and effective products they need to protect their health. Approved Bodies play a critical role in the supply of medical ...

BioWorld - Wednesday, August 6, 2025 See today's BioWorld MedTech Home » MHRA tackles risk classification for digital mental health tech To read the full story, subscribe or sign in.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced important new steps to secure access for patients to the latest medical technologies available in Europe and other ...

Across the world, demand for mental-health support is exploding. Anxiety, depression, and sleep disorders are no longer fringe concerns but are headline issues, with health services struggling to keep ...

The U.K. Medicines and Healthcare Products Regulator Agency dropped a guidance for digital mental health technologies that clarifies several key points, such as when the DMHT qualifies as software as ...