The importance of the EUDAMED packaging system for the regulation of medical devices in the EU
The EUDAMED packaging system is an indispensable part of the broader EUDAMED system, which was developed by the European Commission to improve the regulation and surveillance of medical devices in the European Union (EU). It plays a critical role in the collection, management and communication of medical device packaging information, contributing significantly to the safety and efficiency of the marketing of these products.
Packaging Hierarchy is a central aspect of the Unique Device Identification (UDI) regulations for medical devices and refers to the structuring and labeling of products and their packaging. Labelling, i.e. the marking of MedTech products, plays a decisive role here.
The UDI is a unique identification code for medical devices and pharmaceuticals that is used to track products throughout their lifecycle to facilitate recalls, quality control and other regulatory purposes. Many countries mandate the use of UDI numbers for medical devices, although regulations may vary by region.
The packaging hierarchy in the EUDAMED system
According to UDI regulations, each individual product receives a unique identification number, its own UDI-DI (Device Identifier). But because medical devices are often sold in packaging, a packaging hierarchy is created. For example, a single latex glove receives its specific UDI-DI, for example, the number 01111111111116. However, when multiple latex gloves are contained in a package, that box receives a new UDI-DI, for example, the number 0222222222222. This new UDI-DI represents an independent identifier for that level of packaging.
It is important to note that each latex glove in the box retains its original UDI-DI, i.e., the number 011111111116, because it is still a sales unit that exists within the box. Thus, 011111111116 is assigned as a child UDI to package 0222222222222.
This packaging hierarchy enables effective tracking and traceability of medical devices throughout the supply chain and throughout their lifecycle. It ensures consistency and accuracy of identification data, which is critical for patient safety, management efficiency and compliance with regulatory requirements.
By applying Packaging Hierarchy correctly and consistently, manufacturers, distributors and healthcare facilities can ensure improved transparency, manageability and safety with respect to medical devices. Clear structuring and labeling of products and packaging also facilitates compliance with UDI regulations and helps to improve the quality of healthcare in the European Union.
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