How to apply IEC 62366 and what shall be changed in establishing a Technical File

K

kimovitch

#1
Hello,

I have a doubt on how to apply IEC 62366 and what shall be changed in estbalishing a Techfile related to this standard.

IEC 62366 has been released in 2007 and is an Harmonized Standard for the 93/42 since november 2008 with no transition period. So my understanding is that now all medical device have to comply with this standard.

Does that mean that for my MD which has been CE marked last year without a specific usability engineering file I now have to realize such file?

How does it impact the Tech File? Anybody has an example of a UEF?

Thank you
 
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sagai

Quite Involved in Discussions
#3
Hi,
the usability engineering file not necessary a separate file from your recent design output documentation, only the usability review record (URR) as part of your design review.
This URR actually records how do you conforms with each of the requirements of the standard (IEC62366 / IEC 60601-1-6). (can point to the corresponding part of your QMS and of your requirement engineering files)
br
Sz.
 
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