Labelling in Medical Device Software

[sarkalgud]

What is the meaning of labelling a medical device software?
There is "version" of the software. Does this satisfy the needs of labelling?

There are user-guides for use of software. Do such user-guides need to be labelled?

Are there any other pieces of medical device software that need to be "labelled"?

Thanks!

 

[yodon]

Take a look at this page on the FDA website: Device Labeling

Yes, your labeling includes the software version number and your instructions for use. It may also include your website. Your user's guide needs to be uniquely identifiable and have a revision identification (just like all other controlled documents)

 

[Pads38]

We wondered how to label software as well.

Medical devices have some 'mandatory' labelling - such things as manufacturer's name and address, identification of the product (including version number), CE mark, notified body number (if applicable) etc etc.

When we provided software on CD it was easy to add that information to the CD label.

With other forms of distribution now used, we now use a splash-screen, when the software is started, to display the required information. This screen can also be called from the 'About' menu button.

This approach has been fully accepted by our Notified Body.

 

[sarkalgud]

Thanks very much for your reply!

When user guide is labelled, is there a need to tie user guide label to a version of the software.

Example: User Guide with label LBL-0011 is meant to be used with software version 1.1.0

If yes, then do you maintain a document that maps software version to user guide version and any website version.

 

[yodon]

I'd turn it around: have the software say what version of the user's guide is applicable. It's quite likely the software will be updated without any need to update the user's guide.

 

[Lilla]

Hi Everyone,

For a downloadable category 2 software, we need to add the UDI, or the version number is enough?

Thanks in advance!

 

[sarkalgud]

If software is Class 2 as per FDA classification, then we need a UDI that comprises of device number (a constant number), product identifier (version number), a part number (which is a constant number)

 

[Lilla]

If software is Class 2 as per FDA classification, then we need a UDI that comprises of device number (a constant number), product identifier (version number), a part number (which is a constant number)

Thank you! Can we give these numbers, or should we request them?

 

[sarkalgud]

Thank you! Can we give these numbers, or should we request them?

Your company should have a process to assign these numbers to the software product. Example: Device number is 6 digit long etc etc And any new software product will get the next incremental number