Implementation of UDI: A key step forward in the traceability of Medical Devices
As European regulations and Regulation (EU) 2017/745 mandate a unique and international identification system for Class I medical devices starting May 26, 2025, our group, SGH Medical Pharma, is taking a major step forward by ensuring the operational deployment of the UDI (Unique Device Identification) system.
What is UDI?
UDI is an international system for the unique identification of medical devices. Its goal is to enhance traceability throughout the product lifecycle, from manufacturer to patient.
Each UDI consists of two components:
- UDI-DI (Device Identifier): a fixed identifier linked to the manufacturer and the product.
- UDI-PI (Production Identifier): a variable identifier including production data such as serial number, lot number, manufacturing date or expiration date.
Why is UDI essential?
This system is a key driver of safety, transparency, and efficiency in the management of medical devices. It enables:
- Better management of recalls and incidents
- Clearer communication with patients and healthcare professionals
- Stock optimization and supply chain security
- Reduction of medical errors and counterfeiting
Where compliance meets innovation
In compliance with Regulation (EU) 2017/745 on medical devices (MDR), this alignment is much more than a legal requirement: it is a commitment by SGH Medical Pharma to quality, transparency, and the safety of medical devices.
What is changing in practice
The labels of all our Class I medical devices now include the UDI code. This unique marking ensures reliable, fast, and standardized identification of each product throughout the value chain.
