EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing

qu1nn

Involved In Discussions
#1
Havent been here in a while, reviewing the state of regulatory and noticed AC:2018 being stated in the applicable harmonized standard listing: 2020/437 25.3.2020
If I am reading the confusing maze correctly the AC:2018 is currently required .

Can someone throw me a bone as to what the AC:2018 incorporates, and am I correct in interpreting the applicable listing as being required currently?

Thanks
qu1nn
 
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Jean_B

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#2
FOR ISO 13485 AC:2018 was accepted as NEN EN ISO 13485 C12:2018.
Based on that it is about 8 pages of actual corrections to the Z annexes. 4 for ZC, 2½ for ZB, and 1½ for ZA. One annex per 'old' directive.

I would interpret it as you do, though they are not so much new requirements as much as clarification on what might be missing still.
 
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