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Addition of the device in EU market

Discussion in 'EU Medical Device Regulations' started by Olga Zhuk, Jun 10, 2024.

  1. Olga Zhuk

    Olga Zhuk New Member

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    Hi!
    I have a question on the addition of new product in the EU market. Should I notify our NB on that first and get their approval on the device's classification? Or I should reach EU AU for that?

    Thanks!