CE-Labeling requirements: Year of manufacture for Software

Quarma

Starting to get Involved
#1
My client has a Software (SW) product. No hardware, just standalone SW.
No DVD, no CD, just a filename and it is downloaded to the customer site.

The essential requirements 13.3 require for the label:
The label must bear the following particulars:
- (l) year of manufacture for active devices other than those covered by
(e [= has use by date]). This indication may be included in the batch or serial number;

The technical file reviewer (BSI Germany) says:
-SW is manufactured (the process from getting it from the manufacturer to the user= hospital)
- it needs to be labelled. [filename is label]
- the label needs to fulfill the requirements above.

Thus my SW filename needs to contain a year of manufacture.
The filename [- Year of manufacture ] changes every year, even though my SW does not change. This makes no sense to me.

My thinking is, that SW is uniquely identified by revision number. I control the content, so make sure that every bit is the same, when transfered. The year of manufacture is not relevant for SW, it is not a property of the SW. The reviewer insists there is production for SW.

Questions:
1) Has anybody encountered this interpretation of the Essential requirements ? -(year of manufacture required for standalone SW)
2) Does that make sense to anybody ?
3) Does anybody have a year of manufacture in their SW-filename or on CD?
4) Is the concept of "production" for standalone SW common ?

thank you for your sharing your experiences.
 
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yodon

Staff member
Super Moderator
#2
I think the disconnect may be how "manufactured" -v- "installed" is being used.

Your build date (or however you construct what's downloaded) should be (IMO) the "manufacture" date. The install date is not all that relevant. (Rather analogous to hardware, in this case.)
 
#3
The ER 13.3 requires the presence of several other information (e.g. the name or trade name and address of the manufacturer).
The filename is not adequate to contain all the required information.

I suggest to include the labeling in the application itself. For instance adopting the following approach:
- a info screen available in the application that contains the information required in the labeling
- the same screen (or a similar one) used as splash screen when the application starts
- the same screen displayed and available during the installation (i.e. when the user starts the downloaded file).

Moreover you can provide the same information on the website before the user downloads the application (for instance a labeling link).

Regarding the year of manufacturing this is the year in which that version of the application was released. You do not have to update it every year but just when you release a new version.




 

kreid

Involved In Discussions
#4
I have come across a similar problem:

First, remember that the 'labelling' includes the software GUI (assuming you have one).

The solution that I used was to take the year of manufacture as the year the version of software was released and then put this in the product details section under the 'Help' drop-down.

I think the main problem is that you need your tech file reviewer to realise that standalone software might not fit perfectly into the Essential reqs checklist.
 
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