ISO 20417:2021 - confusing wording at 6.1.3

[ThatSinc]

Hi All,

Getting working on the new 20417 standard and a gap assessment from EN1041 and cross referencing with the GSPRs and have found that 20417 is possibly the worst standard I've ever read, from a formatting perspective.
And considering that it's a standard to assist in ensuring that relevant information is provided to users in a coherent manner, the irony is not lost on me.

Can anyone advise, taking the definitions into consideration, whether there is any practical difference between 6.1.3.a) and 6.1.3.b) in the standard?
If the label shall include al of the following, and then the device must be labelled with all of the following - are these not the same thing?

I'm hoping that providing this small extract is allowed - if not, please delete and I will write out the issue.




Cheers, TS.

 

[jansayshello]

Hello

I agree that there's a lot of weird grouping and inaccurate naming of information in the 20417 standard, making it difficult for people to read and follow. The irony is not lost on me either!

My only explanation for the above would be that:

6.1.3 a) Specifically covers device identification
6.1.3 b) Specifically covers warnings related to storage and handling, and special use warnings

If these were labelled with their own explicit, specific headings rather than just being sub-divided into parts a). b), c) etc I think the requirements would be a bit easier to follow.

Really, I think the top level title of 6.1.3 ought to be renamed "information relating to the device or accessory" as only 6.3.1 a) really relates to device/accessory identification.

For what it's worth, I'd personally cover the labelling requirements from the applicable regulation(s) (e.g. with a GSPR checklist - including requirements 23.2a to 23.2s) and use the standard as a guide for specific implementation.

Jan

 

[ThatSinc]

For what it's worth, I'd personally cover the labelling requirements from the applicable regulation(s) (e.g. with a GSPR checklist - including requirements 23.2a to 23.2s) and use the standard as a guide for specific implementation.

That's probably what I'll end up going with - though will always get the question from NB review of "why didn't you apply this standard" if it's not referenced.

 

[indubioush]

If the label shall include al of the following, and then the device must be labelled with all of the following - are these not the same thing?

These are not the same thing. In many cases, the label is not applied to the device. The label is discarded along with the packaging.

 

[ThatSinc]

These are not the same thing. In many cases, the label is not applied to the device. The label is discarded along with the packaging.

But the statement "the medical device shall be labelled.." doesn't mean it must be on the physical device itself. The definitions of label (and the activity labelled) and marking (and the activity marked) are clear in that.