Unique Device Identification – EU UDI

The UDI (Unique Device Identification) is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. The affixing of the UDI is an additional requirement for labels or on the device itself, it does not replace any other marking or labelling requirements. Only the manufacturer may place the UDI on the device or its packaging

A UDI has two identifiers,

  1. UDI Device Identifier (UDI-DI)
  2. UDI Production Identifier (UDI-PI)

The Basic UDI-DI is the primary identifier of a device model. The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.

The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

Some of the codes for UDI are given below;

(01) Device Identifier Number (GTIN)

(10)    Lot Number/Batch Number

(11)    Manufacturing Date

(17)    Expiry Date

(21)    Serial Number

Reference

EU Medical Devices Regulation (MDR 2017/745) April 5, 2017.

Myself Neethu Jino, Jr. Consultant at I 3 consulting, writing this article to share my experiences. If you need more information please write to me, na@i3cglobal.com

One Reply to “Unique Device Identification – EU UDI”

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s