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!
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!