Current version of EN62304/A1

[regcos]

Hi all,

I am studying the EN62304/A1 and I have a question:

"The first edition of IEC 62304 was published in 2006. This amendment is intended to add requirements to deal with LEGACY SOFTWARE, where the software design is prior to the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives"

As "current version" we can consider the EN62304:2006 or the whole EN62304:2006/amd1:2015?

 

[Marcelo]

Re: Current version

In principle, "current version" is EN62304:2006/amd1:2015.

 

[regcos]

So do you confirm that a medical device software marketed in 2010, when complying with EN62304 today can be handled as a Legacy Software, thus not requiring the whole documentation but only what is stated in Section 4.4 of EN62304/A1?

 

[Pads38]

The amendment has not, yet, been published in the Official Journal (latest is May 2016) - so the current EN version is EN 62304:2006/AC:2008 (corrigendum published 2008).

But the latest version of IEC62366 has not yet been listed, and I have successfully used that standard (the Annex C for legacy usability). I highlighted the fact taht it was not yet harmonised and our NB did not object to it's use.

 

[Marcelo]

So do you confirm that a medical device software marketed in 2010, when complying with EN62304 today can be handled as a Legacy Software, thus not requiring the whole documentation but only what is stated in Section 4.4 of EN62304/A1?

No, I only mentioned that the "current version" in the text "The first edition of IEC 62304 was published in 2006. This amendment is intended to add requirements to deal with LEGACY SOFTWARE, where the software design is prior to the existence of the current version, to assist manufacturers who must show compliance to the standard to meet European Directives" is the version + amendment. This is always true when standards in general say "current version".

 

[Marcelo]

Anyway, although the current version as read does mean the current full version due to some technicalities, the idea of the requirement was to give a way to comply to devices that were created to 2006, not 2015.