What’s Happening in the UK and Switzerland The implementation and extensions of EU MDR/IVDR have caused significant stress on regulatory departments. These challenges have been compounded by Brexit and the UK’s announcement that it would not adopt EU MDR/IVDR and the Swiss National Council’s vote to allow FDA-approved devices into the Swiss market. During …
Software and Artificial Intelligence as a Medical Device Earlier this month, the UK Medicines & Healthcare Products Regulatory Agency (MHRA) issued the guidance document, “Software and Artificial Intelligence as a Medical Device.” The guidance brings together current guidances, advice and regulatory requirements for Software as a Medical Device (SaMD) and Artificial Intelligence as a …
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