UDI Requirement at home patient use

R

RegAffairSpec520

Registered
A company I'm working with is having lots of discussions on the UDI carrier requirement for devices, especially regarding language around direct marking.

The device controls an active implantable device (both Class III), but is a non-sterile, at-home use controller for the patient. As it's a single patient device and does not go through reprocessing, cleaning, or sterilization procedures, the direct marking requirement was not deemed necessary. However, the UDI carrier information is not on the label adhered to the device itself either and I'm arguing that it needs to be because of the intended use and the intention of the requirement.

As intended, the UDI carrier information just on the package label is not sufficient for the device traceability. A patient will lose that package immediately. However, with the language of the MDR, it is hard to cite a direct requirement that the device be marked with the UDI carrier on the device label. "Label" in the MDR has a broad definition including both the device label and all package level labels. "Direct Marking" has no definition in the MDR.

It's my understanding that the UDI carrier info is to be on the device (either marking via label, or direct marking via laser, etch, ink, etc.). My case does not specifically meet the requirements for direct marking. However, how do I present that it still needs to be on the device label and not just on the package level labeling?

Thank you
 
J

Junn1992

Quite Involved in Discussions
Yes, this is a tricky one. Because the UDI requirements are 'in addition' to the labelling requirements, and the UDI requirements allow the UDI to appear on the device or on the packaging.

However, Annex I, 23.1(b) 'The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices'

So I would say the allowance for UDI to not appear on device itself, but on the packaging is due to space constraints. Also,

Annex VI, 4.7 "If there are significant constraints limiting the use of both AIDC and HRI on the label...For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC."

HTH
 
R

RegAffairSpec520

Registered
Thanks! I think that 23.1(b) may be just the support I'm looking for. Because of the nature of the product group, a lot of the devices are implantables that fit the exception for the UDI carrier on the device. This is explicitly calling for the UDI carrier to be on the device itself unless fitting one of the exceptions (size/intended use/etc.).

Thanks so much for assistance here.

For the Annex VI 4.7 language, I've been getting caught up with people on the use of "label" in this clause as MDR has that loose definition of "label" so I haven't been able to win points with that one.
 
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