Introductory guide to MDR/IVDR by the UK regulator

The British MHRA has issued an introductory guide to the MDR and IVDR, which is user-friendly and provides an overview of the main novelties introduced by the regulatory texts.

27 slides of the MHRA guide encompass new definitions, classification of devices, UDI system, placing a device on the market and new obligations of economic operators, especially the need for proactive and preventive post-market surveillance.

The guide invites the reader to consult the specific provisions of both Regulations as to obtain an in-depth understanding of the new regulatory requirements.

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