UDI

November 16, 2018

Unique Device Identification

 

Unique Device Identifier (UDI) established by the FDA

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.

⇒ see regulations here (FDA)

 

Unique Device Identifier (UDI) established by the EU

The Unique Device Identifier (UDI) is used to uniquely identify the products. When the European regulations for medical devices and in-vitro diagnostics (MDR and IVDR) come into effect, registration of the UDI and the associated product information in the European database Eudamed is mandatory.

UDI is to be applied to the product as a machine-readable mark (e.g. barcode) and in plain text.

How to request a Unique Device Identifier (UDI)?
The UDI is not assigned by the authorities or the Eudamed database. It is assigned by the so-called allocation authorities, with whom you contact.

UDI-Registration

The unique device identification (UDI) is a unique numeric or alphanumeric code related to a medical device. It allows for a clear and unambiguous identification of specific devices on the market and facilitates their traceability. The UDI comprises the following components

  • a device identifier (UDI-DI)
  • a production identifier (UDI-PI)

These allocation bodies are listed in Article 120(12) MDR: GS1, HIBCC and ICCBBA. In an implementing decision of the EU Commission the IFA GmbH was also added. The regulation as well as the implementing decision can be found on the websites of the European Union.