Direct-Marking Requirements under MDR 2017/745

#1
Hello - quick and to the point, thank you for any help you can give.

Does MDR 2017/745 have a similar exception as 21 CFR 801.30(d); ie. can the UDI indicated on the label of a class 1 device only contain the UDI-DI?

Does MDR 2017/745 Annex VI s 4.10 require the UDI-DI and UDI-PI to be directly marked on the device, or can the UDI carrier on the device only include the UDI-DI, while the UDI carrier on the label includes the UDI-DI and UDI-PI?

Can the exception in MDR 2017/745 Annex VI s 4.10(b) be used to justify only marking the UDI-DI portion of the UDI carrier where the size of the full UDI carrier would make direct marking it not technologically feasible?

The device in question, a class 1 reusable device that requires cleaning and sterilization before reuse, has a UDI-DI, a lot number, and manufacturing date on the label. It is sold in Europe and the USA therefore, in accordance with 21 CFR 801.40(b), each device's full UDI carrier is the UDI-DI, the lot number, and the manufacturing date. We use the exception in 21 CFR 801.30(d) to only mark the UDI-DI on the device, although we include a full UDI, comprised of UDI-DI and UDI-PI, on the label.

The MDR, under Annex VI s 3.5, says that the manufacturing date does not need to be in the UDI-PI but come now, are we expected to issue different lots with different UDI formats for different regions because of direct marking?

Thanks for any help!

Derek
 
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Junn1992

Quite Involved in Discussions
#2
I would say no. The UDI carrier must include both UDI-DI and UDI-PI under the MDR requirements, there is no exception clause similar to 21 CFR 801.

If you can't fit the UDI carrier, meaning AIDC + HRI on the device, then don't direct mark it at all.

The MDR, under Annex VI s 3.5, says that the manufacturing date does not need to be in the UDI-PI but come now, are we expected to issue different lots with different UDI formats for different regions because of direct marking?
You can still include it in your UDI-PI according to the UDI issuer format. Nothing wrong here.
 
#3
Thank you for your reply.

I have the same interpretation regarding the UDI carrier under the MDR.

I'm not sure how your idea of not marking at all would fly under 21 CFR 801. The UDI-DI in AIDC-only format fits fine so how could we justify not direct-marking the device?

Once it is direct-marked, the slippery slope of including the UDI-PI & the manufacturing date component come in to play.

Am I out to lunch on this? The inconsistent exceptions & requirements really seem to create a monster here. It's there something I'm missing or a different perspective?

Thanks again, I really appreciate the community's help with this and all of the other great questions here.
 

Junn1992

Quite Involved in Discussions
#4
The UDI-DI in AIDC-only format fits fine so how could we justify not direct-marking the device?
The tricky thing about the EU is that there are many notified bodies, whereas in the US you only deal with the FDA. I would advise checking with your notified body on this, since labeling is also part of technical documentation they will review.

Yes the ADIC fits fine, but not the HRI. And UDI carrier = AIDC + HRI. If we look at Annex VI, clause 6.2 reusable devices, it is implicit that the UDI = UDI-DI + UDI-PI.

Once it is direct-marked, the slippery slope of including the UDI-PI & the manufacturing date component come in to play.
You can always bundle the MFG Date into your UDI-PI.

HTH, and this was a great exercise!
 
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