UDI Codes – the key to safety and easier identification of medical devices
As experts in R&D and regulatory requirements for substance-based medical devices, we present you with a Dose of Practical Knowledge to help you better understand legal aspects and industry standards.
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One of the key changes introduced by MDR 2017/745 for European medical device manufacturers is the requirement to assign unique UDI codes to their products. UDI labeling applies only to devices compliant with MDR 2017/745. Products remaining on the market during the transition period are not subject to this requirement.
What are UDI codes?
The UDI (Unique Device Identification) code is a unique identification code assigned by the manufacturer to each medical device. It consists of the following two parts:
- UDI-DI (Device Identifier) – a fixed part of the code that identifies the model/type of the medical device. It is assigned by the manufacturer and generated by an organization authorized to issue UDI identifiers.
- UDI-PI (Production Identifier) – a production identifier containing variable data that identifies a specific production unit of the medical device, such as the batch number, expiration date, or manufacturing date.
Example of product labeling with UDI codes:
UDI codes (Unique Device Identification) are not only a legal requirement under MDR 2017/745 but also a key element in ensuring proper traceability of medical devices at every stage of their market distribution. By implementing UDI codes, enhanced control over medical devices is achieved, helping to minimize the risk of errors and, in turn, increasing patient safety.
Example: Labeling medical devices used in hospitals and healthcare facilities (e.g., surgical instruments, medical equipment) with UDI codes helps improve inventory management, reduce costs, and minimize the risk of using expired or inappropriate products.
Gofarm is already labeling products with UDI codes – in compliance with MDR 2017/745!
At Gofarm, we continuously adapt our processes to meet current regulations. That’s why we have already implemented UDI labeling for medical devices. This step enhances traceability, safety, and compliance with European market requirements.
What’s more, we are about to obtain MDR certificates for 13 medical devices, confirming their full compliance with the latest standards. This ensures that our partners can trust they are working with a manufacturer committed to quality, safety, and transparency.
Check whether the medical devices from your suppliers meet the UDI coding requirements!
