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 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.
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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.
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.