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Do we still have to put UDI if we have DI and lot number seperately on our product ?

#1
Hello !

We are a medical device company (surgical instruments) trying to apply MDD and FDA standards.

Currently, we put DI portion of UDI in Data Matrix on stamped our products. But, we write the lot number numericaly (seperately, not in Data Matrix).

We can provide traceability with this system.

Do we need to change our system and put one DatA Matrix as in UDI form ? If we do , which document, standard or regulation oblige us to do so ? Because in that case, i have to show my boss that it is mandotory to study another barcode system,
 

kreid

Involved In Discussions
#3
EU MDR says that labelling shall be human readable - I do not know of anything specifically about this in the MDD or FDA rules.
 
#4
I have sent the FDA (via GUDID helpdesk) many questions over the years and more often than not, they respond by quoting the rule. Just in case, I would fire off a question to them and see what their response is. Another source would be to ask either GS1 or HIBCC and see what they have to say. We use both (as we are contract manufacturers for a couple of companies) and although both are very good resources, I have nothing but great things to say about HIBCC.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
There is nothing in the MDD about UDI.
FDA UDI requirements stem from 21 CFR parts 801 & 830. If you study them closely you'll know your obligations. There's also a lot of guidance on the FDA's website. You could show all that to your boss.
The MDR also has quite an elaborate UDI scheme. The MDR itself and some official UDI-related guidance are available for free online. You didn't mention MDR, but it's going to affect almost all manufacturers soon.

General note: Your questions are quite specific, and would require investing significant time in review to provide responsible answers, unless someone happened to come across the exact same situation and is willing to share their outcome (which is not obvious because in most cases the outcome is the intellectual property of the employer). I would suggest giving it a little more time - most users don't visit here every day. Keep in mind though that the chances of such specific questions being answered in specific are not high to begin with.
 
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