If the importer of a medical device into Great Britain is not the UK Responsible Person, the importer must inform the relevant UK Responsible Person of their intention to import the device. The UK Responsible Person is required to provide the MHRA with details of all importers.

2 thoughts on “Importers”

  1. What are the pre-requisites to become an UK Importer? What are the Importer requirements in terms of QMS, licensing, dedicated resources, Infrastructure, maintenance, insurance etc?

    1. There are no qualification requirements for importers in the current version of the UK MDR. The only requirement is to inform the UK Responsible Person of your intention to import the device. That said, all UK importers have general obligations, including obligations to check the labelling and applicable marketing rules; but these obligations are not exclusive to importers of medical devices.

      Consult the following pages:
      https://www.gov.uk/import-goods-into-uk
      https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain

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