Exploring the MHRA’s transformational impact on access, experience, and outcomes.
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Guidance: Route B substantial modification pilot
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector
The MHRA has now published the government’s response to its public consultation on future routes to market for medical devices – designed to modernise regulation
MHRA Safety Roundup: January 2026
Summary of the latest safety advice for medicines and medical device users
AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
MHRA opens second round of applications to test cutting-edge AI medical technologies following successful pilot phase.
Guidance: Medical devices: post-market surveillance requirements
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Consultation on the International Council for Harmonisation Guideline Q3E for Extractables and Leachables
The MHRA is consulting with UK stakeholders to gather feedback and comments on an international guideline on the assessment and control of extractables and leachables.