What is UDI?
UDI (Unique Device Identification) is a unique coding system established to ensure the traceability of medical devices. It allows each product to be identified in a standardized manner on an international scale and aims to strengthen patient safety, improve device management and facilitate their tracking.
This system has been made mandatory by several regulations, including the Food and Drug Administration (FDA) in the United States and the European Medical Device Regulation (MDR 2017/745) in Europe .
The Composition of the UDI
A UDI is made up of three main elements:
- UDI-DI (Device Identifier) : a unique identifier assigned to a specific model of medical device. It is fixed and allows the manufacturer and version of the product to be identified.
- UDI-PI (Production Identifier) : a variable code that includes information specific to each production unit (batch number, serial number, manufacturing date, expiration date, etc.).
- Machine and human readable media : UDI is presented in barcode, Datamatrix or RFID form to enable automatic reading and manual entry.
Why is UDI important?
The UDI has several major objectives that directly impact manufacturers, distributors and healthcare professionals:
- Improving the traceability of medical devices : precise monitoring throughout their life cycle.
- Patient safety : Facilitates the rapid recall of defective or non-compliant devices.
- Regulatory compliance : Manufacturers must register their UDIs in regulatory databases such as GUDID (Global Unique Device Identification Database) for the United States and EUDAMED (European Database on Medical Devices) for Europe .
- Optimization of inventory management : rapid identification of products and reduction of distribution errors.
- Better SEO visibility for medical devices on online sales platforms.
Who is affected by UDI?
The UDI concerns all players in the medical device supply chain :
- Manufacturers : responsible for the allocation of UDIs and their registration.
- B2B distributors and resellers : ensure that products in circulation meet UDI requirements.
- Healthcare professionals : use UDI to verify device compliance before use.
How to implement UDI on medical devices?
1. Allocation of UDI
The manufacturer must obtain a UDI code from an approved body, such as:
- GS1
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (International Council for Commonality in Blood Banking Automation)
2. Affixing the UDI to the product
The UDI must be affixed directly to the packaging or to the device itself in the form of a machine-readable code (barcode, Datamatrix, RFID) and in a human-readable form .
3. Registration in the regulatory database
- GUDID (for the United States)
- EUDAMED (for Europe, once fully deployed)
Compliance deadlines
In Europe, the MDR regulation requires gradual compliance of medical devices:
| Device class | Application deadline |
|---|---|
| Class III (high risk) | Already in force |
| Class IIa and IIb (medium risk) | May 26, 2023 |
| Class I (low risk) | May 26, 2025 |
Impact on B2B professionals and resellers
For an online sales site like Procondom.fr , which is aimed at professionals in the sector, the UDI allows:
- Guarantee the conformity of the products sold .
- Ensure product traceability and meet customer regulatory requirements.
Conclusion
UDI is an essential lever for improving the traceability, management, and safety of medical devices. As a B2B distributor or reseller, it is essential to ensure that the products sold comply with this standard to guarantee their compliance and quality. At Procondom.fr , we are committed to offering medical devices that meet UDI requirements to ensure optimal transparency and safety for our professional customers.
