Proposal of EU IVD regulation and IEC 62304

M

Marc_G

#1
Hello,


I heard about a EU proposal about IVD reglementation :
proposal_2012_541_en.pdf

This project use a part of the GHTF recomandations about IVD classification criteria's (Annex VII). This classification is made of letters from A to D.


Do anybody know if this classification will have a direct link with IEC 62304 security classes ?


For Example :
Is IVD class C equivalent to IEC 62304 class C ?
 
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sagai

Quite Involved in Discussions
#2
I think these are classification own its own.
For 62304, the definition of the classification is encapsulated in the 62304 itself, so have a read of it, basically I think that's all.
Cheers!
 
M

Marc_G

#3
Thanks Sagai,

Does anyone know if the project of 2nd edition of IEC 62304 would have a link with the EU / GHTF IVD classes ? (Marcelo ?)
 

Marcelo

Inactive Registered Visitor
#4
The safety classification in 62304 (1st and revision as it?s being written) is, as Sagai mentioned, self-contained, because it?s really only related to the amount of "work" a manufacturing applying the standard will have depending on the "risk" of the device.

This "risk" is not the same as the risk classification from regulatory systems (although the idea is the same - less risk, less burden).
 
E

Erik Vollebregt

#6
Hello,


I heard about a EU proposal about IVD reglementation :
proposal_2012_541_en.pdf

This project use a part of the GHTF recomandations about IVD classification criteria's (Annex VII). This classification is made of letters from A to D.


Do anybody know if this classification will have a direct link with IEC 62304 security classes ?


For Example :
Is IVD class C equivalent to IEC 62304 class C ?
Hi, this classification of IVDs is based on the GHTF model for IVDs, which is not linked to the 62304 risk classes.
There are some interesting software points in the new IVD regulation, like the essential requirement to account for 'mobile computing platform' dependencies.
 
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