The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently published three policy developments as part of its overhaul of medical device regulation in the UK. The AI Airlock, announcement of international recognition procedure for medical devices, and consultation on technical specifications for the In Vitro Diagnostics Regulation (IVDR) signal the MHRA’s continued focus on reform and international alignment in this area. Industry stakeholders should take note and engage with the regulator where possible to have their voices heard as part of the process. 

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