Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Colleagues,
I'd like to have your opinion on the following topic:

My company manufactures both hardware and software (class IIa in EU and class II in US - 510(k) in process) and they can be placed on the market separately.
The different hardware already bear their own UDI and the software (downloadable from iOS and Google Play) bears its own UDI.
Hardware product can be sold with different indication for use:
1) to be used alone
2) to be used with one of our software 
3) to be used by 3rd party developers with our SDK to build specific Mobile Apps.

Now my question is shall I create a specific UDI for all these combinations? Or will be enough to have the the single separate UDIs?

Thanks

Hello Anon

​Just because two devices can be used together, or just because you have decided to market them together, they are not necessarily a system or a kit. Some collections of devices are pretty obviously kits or systems, some are obviously not, and sometimes it's gray. For EU, read through the definitions in MDR Article 22. For US, read the guidance on convenience kits. ( https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-convenience-kits ) 

Whatever feels right for your devices, if you document a sensible rationale, your notified body will probably agree.

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 19-Apr-2021 10:36
From: Anonymous Member
Subject: UDI for Hardware and Software Kit

This message was posted by a user wishing to remain anonymous

Hello Colleagues,
I'd like to have your opinion on the following topic:

My company manufactures both hardware and software (class IIa in EU and class II in US - 510(k) in process) and they can be placed on the market separately.
The different hardware already bear their own UDI and the software (downloadable from iOS and Google Play) bears its own UDI.
Hardware product can be sold with different indication for use:
1) to be used alone
2) to be used with one of our software
3) to be used by 3rd party developers with our SDK to build specific Mobile Apps.

Now my question is shall I create a specific UDI for all these combinations? Or will be enough to have the the single separate UDIs?

Thanks