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Failure to prevent fraud: New Year’s resolutions for corporates
In 2023, Parliament introduced a new corporate criminal offence of “failure to prevent fraud” under section 199 of the Economic Crime and...
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New MHRA guidance on incoming UK Post-Market Surveillance regime
The MHRA has released a suite of guidance on the new post-market surveillance (PMS) requirements for medical devices in Great...
MHRA launches Real-World Evidence programme to support approvals and HTAs
The MHRA has launched a Real-Word Evidence programme to ensure that innovators understand how to use RWE to prove that medical products...
The Innovation Ecosystem report: a roadmap for the adoption and spread of innovation in the NHS
The Innovation Ecosystem Programme (IEP), founded in 2023 with the aim of discovering how best to streamline development and adoption of...
MHRA consultation on medical device reforms: international reliance, removing UKCA mark and aligning IVDs classification with EU
The MHRA has published a consultation on reforms to UK medical device regulations as part of finalising the details of a Pre-Market...
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