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INFO for notification/registration of medical device in UK

Discussion in 'EU Medical Device Regulations' started by Irene, Jun 30, 2017.

  1. Irene

    Irene New Member

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    Hello everyone,

    One of my client wants to put on the UK market a medical device(class IIa) which is already on the Europe Market. They also obtained a EC certificate was issued by the German NB.
    And the legal manufacturing is in Poland.

    Local registration is required?
    What kind on documentation should be submitted?
    What is the registration way of submission?

    Thanks in advance for your help
    Irene P.
     

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