What you need to know – UDI in the MDR

The new Medical Device Regulation 2017/745 (MDR) changed and introduced various requirements to obtain regulatory approval for medical devices in the EU. One of these is the introduction of the UDI – Unique Device Identifier, an identification system for medical devices, and a key element to ensure traceability throughout the supply chain from manufacturer to patient or user of the device.

It’s not a new concept for the medical device industry, as it is also a requirement for devices in the United States market.

The UDI structure is specified in the MDR, with two main elements: UDI-DI and UDI-PI. The UDI-DI, device identifier, is the static part of the number, identifying a specific product in the company. The UDI-PI, production identifier, is dynamic, identifying the device production unit, possibly including information about the lot number, expiry date, serial number, and others.

Simultaneously, there is also a requirement for a Basic UDI-DI, which is described as being the “main access key” for information related to the medical device. It is not used in the supply chain, with its value being tied to administrative purposes, such as certificates, Declaration of Conformity, Certificate of Free Sale and EUDAMED registration. It’s an identification number for a group of products, with only one Basic UDI-DI necessary for devices within the same category: intended purpose, risk class, essential design and production/manufacturing characteristics.

One or various UDI-DI can be included under the same Basic UDI-DI.

The UDI carrier (the format in which you can see the UDI) includes only the UDI-DI and, if applicable, the UDI-PI, and must be readable to both humans and machines.

The UDI system applies to all medical devices marketed in the EU, including devices being developed and those that are already on the market, with only a few exceptions (such as custom-made devices and devices for investigation purposes). It should be placed on the device, or on the packaging when the former is not possible.

The deadlines for implementation of the UDI carrier depend on the risk class of your product (higher risk classes require quicker implementation).

Find more information related to the dates of application of the UDI carrier on your device and other UDI information in our document UDI – Deadlines and Basic Information –  EU MDR 2017/745 – download for free in our shop.