UDI Requirments Gap Analysis - EU MDR vs FDA CFR

#1
Does anyone have or know of a document which maps out the key differences between UDI requirements as per the US FDA CFR
vs the EU MDR? A Gap analysis document perhaps?
 
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shimonv

Trusted Information Resource
#4
It's a good idea to make a comparison chart between US and EU MDI.
If someone can do that - I will ask my Chinese colleagues to add their input.

That would be very useful for everyone in the medical device cove.
 

Marcelo

Inactive Registered Visitor
#6
A lot of countries are creating or planning to create their own Udi...maybe, instead of unique, they should change to Universal or something like that (I think in English it would have have the same meaning, but...)?
 

DitchDigger

Starting to get Involved
#7
I've been working around the US, EU, and IMDRF (Guidance, Application Guide) since most jurisdictions where we do business will be aligning with one of these three.

I don't have any sort of "universal" gap analysis handy, but (just off the top of my head) relevant to the products produced where I'm at, I found that:
  • EU or IMDRF didn't carve out any PI exemptions for their lowest class devices.
  • FDA didn't provide any guidance specific to configurable medical device systems.
  • EU and FDA differed on prioritizing human-readable or machine-readable direct marks when space for both was an issue.
  • FDA's interpretation of when a direct mark is required is more narrowly defined in their guidance documents, as opposed to the EU which is more broad. (But that FDA requirement for direct mark seemed to have something like laser etching in mind, whereas I believe a robust "paper" label affixed directly to the device proven to remain affixed and legible under reprocessing and use conditions for the life of the device would satisfy any direct marking requirements under these three regimes.)
Differences weren't huge for us, but I wanted to ensure that if we're going through this big project, we wouldn't have to revisit in a few years for Europe. The types of devices your company manufactures will likely inform which differences are relevant.

Unfortunately I never ran across any point-by-point analysis of differences between the different regulations.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
A lot of countries are creating or planning to create their own Udi...maybe, instead of unique, they should change to Universal or something like that (I think in English it would have have the same meaning, but...)?
Oops, it's Unique, not Universal...
Not sure what happened, I probably had a cerebral meltdown. LOL.
 
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