What UDI and EUDAMED Obligations Apply to Medical Software?

Introduction to UDI and EUDAMED

The Unique Device Identification (UDI) and the EUDAMED database are central elements of the regulation of medical devices in the European Union. These systems were introduced to improve the traceability and safety of medical devices, including medical software. The UDI allows for the unique identification of products, while EUDAMED serves as a central database for the collection and management of information about medical devices.

UDI Obligations for Medical Software

Specific UDI obligations apply to medical software classified as a medical device. Manufacturers are required to create a UDI for their products. This UDI consists of a combination of alphanumeric characters that enable unique identification of the product. The UDI must be affixed to the product itself or to the packaging, where technically feasible. Furthermore, manufacturers must ensure that the UDI is registered in the EUDAMED database to ensure traceability.

EUDAMED Obligations

EUDAMED is the European database for medical devices that stores information about all medical devices approved in the EU. Manufacturers of medical software must enter relevant information about their products in EUDAMED. This includes, among other things, the UDI, product names, classifications, and information about the manufacturer. This database serves not only for market surveillance but also for transparency and safety for users and patients.

Conclusion

Compliance with UDI and EUDAMED obligations is crucial for manufacturers of medical software. It not only ensures legal compliance but also contributes to the safety and traceability of medical devices. Manufacturers should therefore engage thoroughly with the requirements of Regulation (EU) 2017/745 and the specific UDI guidelines to avoid potential legal consequences.