UDI for consumable/replacement components under the MDR

#1
My question is related to Annex VI Section 3.6, "Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI."

At the most basic level, our device consists of an active base unit that is connected to an air-filled bulb to measure tongue strength. The base unit and bulb must be used together to achieve the device's intended use. The bulb is replaced with each new patient because it goes in the patient's mouth. The device is sold in a carrying case that includes 1 base unit and 5 starter bulbs. We also sell replacement bulbs separately.

Based on Article 23, we consider these replacement bulbs to be a component (not an accessory) because they are integral to the device. Because changing from one bulb to another does not significantly change performance or safety, Article 23(2) does not apply, and therefore this component is not considered a device in its own right.

This would imply that we should not assign a UDI to these replacement bulbs, because only a component that is considered to be a device should be assigned a UDI per Annex VI 3.6. However, we are planning on applying UDI labeling to these bulbs for the US market (it's a gray area, but since manufacturers are entering replacement toothbrush heads in GUDID, it seems like the thing to do for our bulbs as well). We don't want to make separate bulb inventory for the US and EU, and it seems like UDI labeling could only improve device safety, even if it's not required by the MDR.

My concern is that we might raise eyebrows with our notified body if we apply UDI labeling to something that we do not consider a device. Does anybody have an opinion about whether we should or shouldn't put UDI labeling on our replacement bulbs? Thank you!
 
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#2
Just wanted to follow up on my parenthetical above about UDI labeling of replacement parts in the US. I emailed FDA's UDI Help Desk about this, and they said that if a part is a component, a UDI is not required, even on replacement parts. So as long as we're confident that the bulb is a component and not an accessory, UDI labeling is not needed for either EU or US markets.

Here's the full text of their response if it helps anyone else:

"For purposes of UDI requirements, a component is any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. A component is not a finished device, is not cleared or approved independently from the finished device, and does not require a UDI. A replacement component does not require a UDI, even if sold separately.

"For purposes of UDI requirements, an accessory is a finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. An accessory may be cleared or approved as a separate device. If an accessory is packaged and sold with a parent device as a device “system”, the label of such system would be required to have its own UDI, but the label of the accessory as packaged in this particular situation would not be required to bear a separate UDI. However, an accessory that is individually labeled, packaged, and intended to be sold separately from the parent device, including a replacement accessory, requires its own UDI."
 

med_cert

Involved In Discussions
#3
Just wanted to follow up on my parenthetical above about UDI labeling of replacement parts in the US. I emailed FDA's UDI Help Desk about this, and they said that if a part is a component, a UDI is not required, even on replacement parts. So as long as we're confident that the bulb is a component and not an accessory, UDI labeling is not needed for either EU or US markets.

Here's the full text of their response if it helps anyone else:
...I."
Based on your description, your replacemenet bulb is not a "component"... As defined: "...a component...is included as part of the finished, packaged and labeled device". Your device is sold as "consumable" not as a "spare part". I would say it should be marked with the UDI.
 
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