UDI

Unique Device Identification

A globally recognized system used to mark and identify individual medical devices through their distribution and use. Established by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Commission, the UDI system assigns a unique code to each medical device model and sometimes to individual units. The goal is to improve patient safety, streamline recalls, enhance post-market surveillance, and foster greater transparency throughout the healthcare supply chain.

What is UDI?

A Unique Device Identifier (UDI) is a combination of numeric or alphanumeric characters that identifies a specific version or model of a medical device. It is comprised of two parts:

1. Device Identifier (DI): A fixed component that identifies the device manufacturer and the specific version or model of the device.
2. Production Identifier (PI): A variable component that may include the device’s lot or batch number, serial number, manufacturing date, and/or expiration date, depending on regulatory requirements.

These components are encoded on the device label in human-readable and machine-readable formats (e.g., barcode or DataMatrix). They are submitted to a centralized UDI database maintained by regulatory agencies.