MDR UDI: What It Is And How To Get It At GS1 Or IFA

Under the EU MDR, every medical device needs a so-called UDI, which stands for “Unique Device Identifier”. The whole scheme has caused a huge amount of confusion because, quite frankly, the concept of MDR UDIs is rather convoluted.

We’ve published quite a lot of content on this topic in the past, so this is my attempt to summarise all of that. And once you’ve read it, you should have a solid understanding of MDR UDIs! So let’s get started.

What Is a MDR UDI?

The UDI is a piece of text (a string, if you’re a programmer) which uniquely identifies a medical device. It consists of three things:

  • Device Identifier (UDI-DI): Unique for same versions of a medical device, e.g. software version 1.0.
  • Production Identifier (UDI-PI): Unique for the same batch of a medical device.
  • Basic UDI-DI: Groups devices of the same intended purpose together. This one hardly changes.

If you’re thoroughly confused about MDR UDIs, I agree. It takes smart people to come up with simple systems, and by that measure, this system is not simple, and I’d postulate that the people behind it might not have been the smartest. Anyway! The good news is that my colleague Sören wrote a great article which goes more in-depth about what MDR UDIs are, check it out here.

How To Get It?

You unfortunately can’t just come up with your own combination of letters for your UDI. Instead, you have to purchase UDIs from UDI vendors. If all of that sounds ridiculous, well.. yep, it is.

There are multiple vendors out there. For some of them, we’ve written separate articles:

.. the main commonality between all of them seems to be that 1) they have weird abbreviations and 2) they have crappy websites with very opaque pricing models. It’s a shady industry – welcome to building a medical device.

If you choose IFA as MDR UDI provider, we also have described a small “hack” you can use to save some money. Check it out here.

Here’s a more in-depth article by Sören on how to purchase your UDI.

Videos

If you’re still completely confused by MDR UDIs, you’re not alone. We’ve recorded a bunch of videos in which we walk you through the process of purchasing one. I’ll link them here once I’ve finished uploading them!

On a different note: Do you still have lots of questions about the EU MDR and would you like to talk to a human? No worries! We offer our Regulatory Strategy Workshop to companies like yours, in which we sit down with you for two hours, answer all your questions and come up with a plan with which you’ll bring your product to market. For only 400€!

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a self-guided video course which helps you create your documentation all by yourself. No prior knowledge required.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to automate your compliance, look no further. We’ve built Formwork, and it even has a free version!

And finally, if all of this doesn’t sound helpful and your situation seems hopeless, check out our consulting 🙂

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