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.
 
#4
Hello Caitlin, or whoever else can help on this topic. I'm trying to help a client with a very similar situation you (Caitlin) presented last year. What did you end up doing finally? Did you end up marking your spare/replacement part with a separate UDI numbering? For both US and EU? In my client's case it is sold separately if needed. Really appreciate your response on it. Thanks.
 
#5
Hi Jose--We ended up deciding not to UDI mark the replacement parts for the US this year (because we've got the letter from the UDI help desk supporting not marking them). However, we are planning to add UDI to our replacement parts before we enter the EU. Even though it could be argued that they don't need UDI, it seems good to do it to cover our bases. Our UDI labeling approach has not been reviewed by regulators/notified body in the US or EU, but I'll try to remember to update this thread if we get any feedback in the future.
 

Junn1992

Quite Involved in Discussions
#6
I am not sure about the US, but under the MDR I do not see why this does not require a UDI.

The way that I understand Article 23 is that it refers to items that do not fall under the definition of "accessory" or "system", for example replacing battery packs, or loose screws etc.

The way I see it, the base + bulb have to work together to achieve intended purpose, as such it falls under definition of "accessory", and requires it's own UDI.

(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);
 
#7
I am not sure about the US, but under the MDR I do not see why this does not require a UDI.

The way that I understand Article 23 is that it refers to items that do not fall under the definition of "accessory" or "system", for example replacing battery packs, or loose screws etc.

The way I see it, the base + bulb have to work together to achieve intended purpose, as such it falls under definition of "accessory", and requires it's own UDI.
I appreciate this perspective, Junn. We went back and forth internally last year trying to decide if the bulbs were accessories or components. It could certainly be argued that the bulbs are accessories, as you described in your comment. However, we ended up defining our device as base unit + bulb (because each on its own cannot achieve the intended use). Here is the reasoning that we used in our classification assessment for EU MDR:

Component is not defined in the MDR, but based on the text of MDR Article 23(1), it seems reasonable to define a component as an element of the device that is integral to the device and allows the device to function. Moreover, based on Annex I Section 23.4(k) second indent, some components are consumable and intended for replacement (like the bulbs). Additionally, MDCG 2021-24, Guidance on Classification of Medical Devices, indicates that a product may be a “medical device part or component for replacement” instead of a medical device or accessory.

Although it could be argued that the bulbs are accessories because they enable the base unit to be used in accordance with its intended purpose, we have determined that “component” is a more appropriate term, because the bulb is integral to the device. That is, the base unit alone does not meet the definition of “medical device,” but when it is connected to the bulb, it does. Both components (base unit and bulb) must be connected in order to form a medical device.

These components are not considered to be devices per Article 23(2) because replacing the starter components (provided in the product kit) with replacement components (sold separately) does not significantly change the performance or safety characteristics or the intended purpose of the device.
 

Junn1992

Quite Involved in Discussions
#8
Right, I see where you are coming from. I also agree that it is safer to just get the UDI first before EU entry and see what the NB says when you are applying for CE mark. But do note that once you get a UDI for the bulb, things can get complicated.

- you would have one BUDI for the bulb
- one UDI for individual bulb
- additional UDI for other pack sizes. Eg: pack of 5 needs its own UDI, pack of 2 needs its own UDI, the initial kit of 1 base + 5 bulb needs its own BUDI and UDI's as well.
 
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