The implementation and interpretation of the UDI system for medical devices and in-vitro devices gives rise to questions. Read here how the UDI is compiled and interpreted.
Simple Formula: UDI = DI + PI
The Unique Device Identification (UDI) system required by regulation MDR 2017/745 and MDR 2017/746, and is made of a device identification (DI) and the production identification (PI). The DI and the PI together form the complete UDI.
These two parts of the UDI are referred to as UDI-DI and UDI-PI to better understand they belong to the UDI system.
The requirements:
- The UDI must be placed on each packaging layer of a medical device (and IVD), except the transport packaging.
- Re-usable medical devices need to be directly marked with the UDI
- The UDI needs to be machine- and human- readable
what is the UDI-DI?
The UDI-DI codes for the device ID, which is a unique number per product and manufacturer. The UDI-DI is, in the human readable form or interpretation started with (01) and followed by a 14-digit number.
For manufacturers, the UDI-DI is uniquely to be created per device. Even though the device belongs to a device family, each “size” of the device needs an unique number to easily distinguish between the different products in the device family.
In need of UDI implemenation support? Speak to us and get your free consultation on this topic.
what is the UDI-PI
The UDI-PI codes for production-specific data, i.e. for the following parameters:
- expiration date
- lot number
- serial number
The human readable code or interpretation for these parameters needs to start with:
- (17), followed by 6-digit numeric code for expiration date in the format of dd/mm/yy
- (10), followed by a 6-digit alphanumeric code for the lot/batch number
- (21), followed by a 10-digital alphanumeric code for the serial number
The different forms of the UDI
The UDI must be compiled of a human- and machine-readable part. This can be done in different forms, and some are shown here.
GS1 Barcode
2D Datamatrix code
How Avanti Europe can help
Avanti Europe’s Experts have a decade-long track record and expertise in consulting and hands-on working with different eQMS and eDMS in the Pharmaceutical, Cosmetical, and Medical Device industry. Our experts support your company with hands-on workforce and support in implementation of UDI-code, risk-based process design, documentation, and training for the company staff. Visit our online shop for checklists and other services.
