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NB or NCA control of Authorised Reps and importers under the MDR

  • 1.  NB or NCA control of Authorised Reps and importers under the MDR

    Posted 15-Apr-2022 03:32

    Dear Colleagues,

    Could you please share your expert opinion about the following:

    • Would/could the NBs audit the Authorised Representatives (AR) of manufacturers not established in the EU?
    • Or these ARs would be inspected by the European NCAs?

    Thank you.

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------


  • 2.  RE: NB or NCA control of Authorised Reps and importers under the MDR

    Posted 15-Apr-2022 05:08
    Edited by Valentina Faziani 15-Apr-2022 05:09
    Hi, 

    both NBs and CAs may audit an EU authorised representative.

    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
    ------------------------------

    Original Message:
    Sent: 15-Apr-2022 03:31
    From: Peter Miko
    Subject: NB or NCA control of Authorised Reps and importers under the MDR

    Dear Colleagues,

    Could you please share your expert opinion about the following:

    • Would/could the NBs audit the Authorised Representatives (AR) of manufacturers not established in the EU?
    • Or these ARs would be inspected by the European NCAs?

    Thank you.

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------


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