The life cycle of a medical device also passes from the packaging and above all from the UDI (Unique Device Identification) coding or the unique identifier of the device.
This coding system allows you to quickly and accurately track and recognize all medical devices and IVDs (In Vitro Diagnostic Medical Devices).
This system was first adopted by the United States and other nations, then followed by the member states of the European community through the adoption of the 2017/745 EU Regulation, in order to simplify the tracking of medical devices, intervene immediately in case of accidents and prevent even counterfeiting.
The UDI code must be reported on all levels of the packaging accompanying the medical device. The code must be readable for both humans and machines and to facilitate the process, a linear barcode or a QR-Code is used with the codes in alpha-numeric format next to it.
How the UDI code is composed
The UDI code consists of two parts which are called UDI-DI and UDI-PI.
The UDI-DI (Device Identifier) code is the first sequence of fixed characters, it identifies the medical device and is used to differentiate, for example, a syringe from a heart valve.
The UDI-PI (Production Identifier) code is used for product traceability and encodes variable information such as:
- Lot number
- Expiration date
- Date of production
- Serial number
The UDI code can be found directly on the medical device and allows the device to be recognized even when it can no longer be associated with its packaging or label.
The identification codes that must be assigned to any medical device, from glasses to disposable gloves, to be effectively unique, cannot be assigned directly by the manufacturers, but they must contact a release body.
The release bodies are organizations worldwide that, through certain criteria, distribute these codes to identify each device put on the market.
The application of the UDI Codes was started in 2017 and will have to be fully completed in 2027.
- In 2021, the UDI code must be reported on the labels of Class III and active implantable devices.
- In 2023 the UDI code must be reported on the packaging of Class IIa / IIb devices.
- In 2025, the UDI code must be reported on all packaging of Class I devices.
The packaging design of the medical device is an integral part to ensure that the device arrives on the market in a safe and secure way and from now on it must also be designed to host this new information for the safety of each user and patient.