Global Regulatory Updates #15: Essential Medical Devices Regulation Alerts from the EU July 8, 2024

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  • Опубликовано: 16 окт 2024
  • Here are the 3 Top Essential Medical Devices Regulation Alerts from the EU:
    First Alert: A Q&A on the practical aspects of implementing Regulation EU 2023/607, which amends EU regulations 2017/745 and 2017/746 regarding transitional provisions for certain medical devices and in vitro diagnostic medical devices.
    Second Alert: Another Q&A addressing the extended transitional period under the IBDR, amended by Regulation EU 2024/1860, which includes details on the gradual rollout of UDI and obligations related to supply interruptions.
    Third Alert: Regulation EU 2024/1860, published in the Official Journal on July 9, 2024, covers the gradual implementation of UDI, notification obligations for supply interruptions, and transitional provisions for specific in vitro diagnostic medical devices.
    Stay updated with RegDesk for important regulatory news!

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