Medicines and Healthcare products Regulatory Agency (MHRA) - Implementation of medical devices future regime

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On 21 October 2024, MHRA published a guidance to help medtech manufacturers comply with its updated post-market surveillance (PMS) regulation. The draft Post-Market Surveillance Statutory Instrument was laid in Parliament, and it was signed into law on 16th December 2024. These regulations will come into force following a 6-month transition period on 16 June 2025. The aim of the new regulations is to introduce clearer and more robust requirements for PMS that improve patient safety. Please find...

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