IEC 82304-1:2016 - Health Software - why not?

[MrTetris]

Hello,
IEC 82304-1:2016 - Health Software - Part 1: General requirements for product safety

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

This standard seems to be strongly related to medical software, but for some reason I have never found any medical software manufacturer to claim compliance with it (not that I have much experience, having worked with 3 different companies only). I am very surprised, and would like to understand why.

Maybe because I work in Europe and MDD Essential Requirements can be covered without being compliant to this standard? Just guessing...

 

[Marcelo]

The standard is the product standard applicable to SaMD (which is one type of medical device software). The standard is new, and is not recognized or harmonized yet with regulatory requirements, so that's part of the reason of it not being "used" yet.

 

[MrTetris]

Thank you very much for your answer Marcelo.

 

[Jesse Shearin]

I am working with companies that are producing SaMD (Software as a Medical Device), and they are preparing their procedures to comply with IEC 82304. One clause that has everyone scratching their heads is 7.2.3.1 c) regarding environmental conditions of transport and storage of the media on which the software is supplied. With most software being deployed as remote installation / download only, this clause seems that it will not apply to the majority of SaMD. However, it would be relevant to those installed on physical media before shipment to customer, e.g. hard drive in laptop included in medical device carts. Has anyone heard of regulatory bodies requiring packaging validation on CD, DVD, Thumbdrives that are used to deliver software?

 

[yodon]

But what about punch cards, paper tape or mag tape? ;-)

I've not heard of any assessment of packaging. Worst case is that the media is corrupted and if that's the case, the software likely wouldn't even load.

 

[Jesse Shearin]

But what about punch cards, paper tape or mag tape? ;-)

I've not heard of any assessment of packaging. Worst case is that the media is corrupted and if that's the case, the software likely wouldn't even load.

Thank you for your feedback, yodon. So far no plans to provide punchcards. I would agree that would be the risk, which is totally acceptable considering the software is installed by company technicians, not the user/customer. There are remote download options for the technicians as well. I think a justification that the clause does not apply because of above reasoning should suffice. However, any feedback from the community would be greatly appreciated.

 

[blah01]

The standard is the product standard applicable to SaMD (which is one type of medical device software). The standard is new, and is not recognized or harmonized yet with regulatory requirements, so that's part of the reason of it not being "used" yet.

Resurrecting an old thread regarding IEC 82304:2016...does anyone know if this standard has now been harmonized and considered state of the art?

 

[Marcelo]

No, no standards have been harmonized as of late. Anyway, you can use any solution you deem fit for Europe, the only things of if you do not use a harmonized standard (and there's no one for SaMD at the moment) you do not gain presumption of conformity.

 

[Pads38]

For a standard to be 'harmonised' and published on the Official Journal (OJ) it must first be considered by the European standards agency (in this case CENELEC) and become an 'EN' standard.

Checking the CENELEC web site shows that EN82304 was published in March 2018. See here:- https://www.cenelec.eu/dyn/www/f?p=...G_ID,FSP_PROJECT,FSP_LANG_ID:1257161,60772,25

Now, when will this get on to the OJ? (the last OJ was Nov 2017).
The problem is with the MDD being replaced by MDR there will need to be an entire new set of standards set against the requirements of the MDR.

Updates to the OJ have been rather slow - the amendment to 62304 is still not shown some six years after it was published - and with the MDR complications it is likely to be even slower.

This fact seems to be recognised, at least it has been by my NB. I have used the 'legacy' annex in 62366 Amd. 1 even though it is not on the OJ. This was accepted without difficulty.

 

[blah01]

For a standard to be 'harmonised' and published on the Official Journal (OJ) it must first be considered by the European standards agency (in this case CENELEC) and become an 'EN' standard.

Looking at the link you provided, it does list the document as "EN 82304-1:2017". therefore wouldn't this mean that it has been harmonized?