Six months since implementation of the UK’s new clinical trials regulations

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How to avoid delays when submitting clinical trial application assessments The UK's new clinical trial regulations came into force on 28 April 2026, introducing a more flexible and risk-proportionate approach to clinical trial assessment. Sponsors now submit a single clinical …

Supporting Digital Mental Health Technology Developers: a new Community of Practice and survey to support regulatory compliance

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In the first of a series of new blog posts focused on compliance issues for medical devices, our Market Surveillance team describes how we will support digital mental health technology developers to understand and navigate the regulatory framework. Background The …

Why post-market surveillance is a priority for the MHRA AI Airlock programme

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It is widely recognised that AI technologies have the potential to positively transform healthcare by improving patient outcomes, supporting clinical decision-making and helping health services work more efficiently. However, AI systems can behave differently once they move from controlled testing …