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

Dr. Oliver Eidel • Getting Started • Updated October 01, 2024 • UDI , Walkthrough

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:

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.

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 need any help with your EU MDR efforts?

We've worked with 100+ companies and helped them certify their devices in weeks, not months. Talk to us now – first calls are free! Check out our services and prices here.

Or, if you don't like talking to humans, check out our Wizard. It's a foolproof, step-by-step video course for getting your compliance done yourself.

And if you're looking for the best QMS software for lean, founder-led companies, check out Formwork. It automates your compliance, and there's even a free version for you to try out!

9:57

Getting a MDR UDI from GS1

Sören Hornof

817 views • almost 2 years ago

What is a MDR UDI? Unraveling the Importance of Unique Device Identification

Anonymous

updated about 1 year ago

What is a UDI in the context of the MDR and FDA?

Accepted answer

A Unique Device Identifier (UDI) is a distinctive code assigned to medical devices (and their packaging) to provide them with a unique identity. Simil

7:22

Getting a MDR UDI From IFA

Sören Hornof

447 views • almost 2 years ago

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Dr. Oliver Eidel

I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.

Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you’re still lost and have further questions, reach out any time!

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