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Circumcision Device: Is it a Medical Device?

Discussion in 'EU Medical Device Regulations' started by khamec, Feb 22, 2017.

  1. khamec

    khamec New Member

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    The question is:

    Is this device is medical device?

    How can we approve that it is medical device?

    Thanks for your forum.
     
    khamec, Feb 22, 2017
    #1
  2. MrTetris

    MrTetris New Member

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    Maybe it is a bit too late to answer, btw the answer is obviously a yes.
    I quote the MDD 93/42:
    ‘medical device’ means any instrument [...] to be used for human beings for the purpose of:
    [...]
    — investigation, replacement or modification of the anatomy or of a physiological process,

    which corresponds exactly to this case.
     
    MrTetris, Oct 31, 2018
    #2
  3. Engr. Rashid Ali

    Engr. Rashid Ali New Member

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    Hi
    Pls read the Article 1(Definitions, Scope) of directive 93/42/EEC
     
    Engr. Rashid Ali, Mar 11, 2019
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