What is Basic UDI?

A registration number that identifies a group of medical devices with the same purpose, risk class and comparable design and manufacturing functions. In general, a Basic UDI-DI consists of four elements:

• A specific start for an issuing body (eg GS1 codes start with “01”)
• Manufacturer code
• Product group code
• Check digit

Basic UDI-DI is used to register the units in EUDAMED and must be referred to in relevant documents (ie in the certificates and technical documentation including operating instructions). However, it must not be stated either on the product packaging or on the product itself. The manufacturers of medical devices are responsible for maintaining a mapping between the Basic UDI-DI and all associated (underlying) UDI-DIs.

Basic UDI (Unique Device Identification) is a system introduced by the European Union’s Medical Device Regulation (MDR) 2017. It requires medical device manufacturers to assign unique identifiers to their products. The primary purpose is to improve traceability and enhance patient safety.

The MDR 2017 defines UDI as “a unique identifier assigned to a device, consisting of a device identifier (DI) and a production identifier (PI).” These two components provide different types of information.

The DI is a globally unique code that identifies a specific device model and its intended use. In contrast, the PI contains production-related information. This may include the production date, manufacturer’s identifier, and batch number.

Together, these identifiers make it possible to trace a medical device throughout its entire life cycle.

One important benefit of UDI is improved access to device information. In the event of an adverse event, incident, or product recall, health authorities and healthcare providers can quickly retrieve relevant data.

For example, this information may include the device’s history, usage, and previous adverse events. As a result, potential issues can be investigated and resolved more efficiently.

UDI can also support more efficient inventory management. Healthcare providers can more easily keep track of the medical devices they use. This may help reduce unnecessary purchases of duplicate or expired devices.

To comply with the MDR 2017, manufacturers must follow the EU UDI requirements. They must include the UDI on the device label and in the accompanying documentation. In addition, relevant UDI information must be entered into EUDAMED.

Overall, UDI improves the identification and traceability of medical devices. It also makes relevant information easier to access when incidents or product recalls occur.

Read all about it here UDI – Unique Device Identifier

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