Check It Out: Free Video Available

While you're gathering your motivation to read yet another article on regulation, let me jump in briefly! We've actually recorded a video on this topic in the meantime. In our videos, we try to be to-the-point and super concrete, so you'll learn exactly what you need to write your own documentation. Check it own below and take a look for yourself!

And if you liked this video, take a look at our UDI video course in which you can watch us literally purchasing UDIs at GS1 and IFA. We explain what we're doing and how you can get your UDIs, too! Much more efficient and cheaper than paying consultants (like us) to do it for you :)

But now, let's move on to the actual article.

Question

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

Short Answer

A Unique Device Identifier (UDI) is a distinctive code assigned to medical devices (and their packaging) to provide them with a unique identity. Similar to a serial number or barcode, a UDI allows for easy identification and traceability of medical devices, e.g. in the EUDAMED database or when communicating with your Notified Body. UDIs can be bought from different number issuing agencies. Those agencies are called GS1, HIBCC, ICCBA and IFA. All of them can also be used in the US for FDA UDIs except IFA.

Long Answer

Both the EU and the FDA require medical devices to have a UDI (Unique Device Identifier). A UDI is a unique alphanumeric code assigned to medical devices, allowing for their clear identification and traceability throughout their lifecycle. Think of it as a digital fingerprint. The UDI comprises two main components: the Device Identifier (DI) and the Production Identifier (PI). And then there’s also the Basic UDI-DI that plays in a league of its own. UDIs are created following an international coding system. In order to participate in this system, you need to register with one of the UDI issuing companies.

Device Identifier (UDI-DI): Yes, this one is really called Unique Device Identifier Device Identifier. It could as well be called “Model Identifier” or “Version Identifier” because this number is assigned to different types of the same device group. You could have a blood pressure monitor that’s available as a professional version and as a direct-to-customer version. Those two models of the same device group would have a different UDI-DI.

Production Identifier (UDI-PI): The UDI-PI provides information about the specific unit of the device, such as its serial or batch number, manufacturing date, or expiration date. It allows for a tracking of single devices of the same device model. This can be handy in the case of a recall when you just want to withdraw devices with certain expiry dates from the market.

Together, the DI and PI create a comprehensive UDI. This UDI is affixed on the device’s label, where it appears in a human-readable format and a machine-readable format (i.e. DataMatrix code or barcode). For devices with only electronic display, no machine-readable UDI is required.

Basic UDI-DI: Its purpose is to group devices with the same intended purpose, risk class, essential design, and manufacturing characteristics. This number described the device group that I mentioned in the description of the UDI-DI. It hardly ever changes, unless you make really fundamental changes. This number can be generated by yourself after you’ve registered with one of the UDI issuing companies.

I’m explaining the entire process of buying, generating and assigning UDIs to medical devices in our new video course. Make sure to check it out!

Where to find the requirements?

The UDI requirements (for the EU) can be found in Article 27 of the Medical Device Regulation (EU MDR) and in Annex VI Part C. If some of the requirements are still unclear after this staggering read, check out the guidelines from the Medical Device Coordination Group (MDCG). The most helpful is probably MDCG 2018-1 which explains when to actually update the Basic UDI-DI and the UDI-DI. And they’ve even created a UDI Helpdesk to help you navigate the jungle of requirements. However, you can also just contact us if you need specific help with your UDIs.