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.
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:
There are multiple vendors out there. For some of them, we've written separate articles:
- GS1: Our article, website
- IFA: Our article, website
- HIBCC: Website
- ICCBBA: Website
.. 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.
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!
