The medical devices and IVDs Regulations (EU 2017/745, EU 2017/746) introduce the Unique Device Identification (UDI) system to identify medical devices within the global supply chain unambiguously. The main provisions are MDR Article 27 and IVDR Article 24.

The UDI system will apply to all medical devices (except custom-made and performance study/investigational devices).

What is the Basic UDI-DI?

Unlike the US FDA regulation, the EU regulations introduce a new identifier, the “Basic UDI-DI”, a regulatory code to group devices with the same intended purpose, risk class, essential design, and manufacturing characteristics. Basic UDI-DI is a numeric or alphanumeric code.

The Basic UDI-DI is the key for accessing device-related information in EUDAMED, and it is mentioned in the relevant documentation, like certificates (including certificate of free sales), EU declaration of conformity, technical documentation, vigilance and FSCA notification form.

On the other hand, the Basic UDI-DI shall not appear on the device label or any trade item.

What is the UDI, and what is the difference between UDI-Di and UDI-PI?