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UDI labeling MDR requirement for reusable medical device accessories


Starting to get Involved
I have a question regarding UDI label for reusable accessories...
According to PART C, Annex VI of MDR there is a requirement
3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.
Does it mean that there are two possibilities - to place UDI on device itself or on its packaging even if it is possible to (for example) engrave the qr code on the device itself?

On the other hand there is a requirement in the same Annex:

4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances: (a) any type of direct marking would interfere with the safety or performance of the device; (b) the device cannot be directly marked because it is not technologically feasible.
Those requirements are contradictory, aren't they?

How do you explain this?
Thank you


Involved In Discussions
Good point... I am facing with simmilar problems...

What if only part of accessory is intended for sterilization? Does this part need a UDI label/engraving (this part however already has serial number)...?
Not contradictory. 3.1 applies to all devices, you then look at the relevant part of section 4 for carrier info:

4.10 covers reusable devices,
4.3 covers single use devices of classes I and IIa packaged and labelled individually...


Involved In Discussions
Our reusable accessory consists of accessory and 4 accessory parts (this is one pack). Only accessory components are sterilizable, main accessory is only to be cleaned.
UDI-DI applies to whole package.
Accessory (including all parts) are packed in a plastic box which has a UDI label (UDI-DI is the same as UDI-DI of accessory, serial number (UDI-PI) is engraved on accessory and on each part seperately).

Is this sufficient or the same UDI carrier should be engraved also on accessory? (engraving on accessory would be technologically very challenging).


Starting to get Involved

Accessories are treated the same as devices in the regulation if it meets the definition of an accessory as defined in Article 2(2). If you feel that you meet the exemption for direct marking due to it not being technologically feasible, I suggest writing up a rationale and including it in your Technical Documentation so that it is clear when you NB audits you that you thought about it and evaluated it against the requirements.
"Not technologically feasible" is harder to prove, especially when ISO 14971 removes costs from the equation (if we can put people on the moon, then we can laser etch individual parts). For example, we offer a reusable device that must be disassembled into 17 discrete parts (mostly silicone valves and their housings) and then autoclaved after each use. Typical users can have 20+ devices used regularly and since the parts are interchangeable, they are all tossed into one big bin of parts for processing. No one would attempt to match the parts together for the same device. Technically, it could be done, however the cost associated with doing so far outweighs the value of the device and so most customers are switching to lower cost disposables.

We interpret the standard to mean that each part is to have a UDI, not just the main device which contains the valve housings. As a result, we have removed the reusable device from markets requiring UDI's.

If anyone has a different interpretation or solution, I would love to hear their thoughts.


Involved In Discussions
So you believe each accessory AND accessory part (which can be removed during re-processing) need an non-removable UDI carrier...?
So you believe each accessory AND accessory part (which can be removed during re-processing) need an non-removable UDI carrier...?
Its not an accessory but an integral component of the device itself. Each valve provides one way passage of oxygen to and from the patient for manual resuscitation. In the spirit of identifying a reusable device, what would be the value of placing a UDI on one or two of the components if each component is integral to it's function? Not unlike a firearm which can be completely dismantled, how do you mark the small springs and firing pin, all of which are essential for its function (perhaps it's a bad example but it's all I could come up with on the fly)?
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