1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Circumcision Device: Is it a Medical Device?

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

  1. khamec

    khamec New Member

    Joined:
    Jun 13, 2016
    Messages:
    3
    Likes Received:
    0
    Trophy Points:
    1
    The question is:

    Is this device is medical device?

    How can we approve that it is medical device?

    Thanks for your forum.
     
  2. MrTetris

    MrTetris New Member

    Joined:
    Oct 29, 2018
    Messages:
    2
    Likes Received:
    0
    Trophy Points:
    1
    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.
     

Share This Page