Small and medium-sized enterprises (SMEs) often struggle with the complexity of the Medical Device Regulation (MDR). A clear UDI strategy can help standardize processes and ease the regulatory burden. For companies with an international focus, EUDAMED can serve as a solid foundation for a comprehensive UDI strategy.

The Unique Device Identification (UDI) system is a globally expanding regulatory standard aimed at improving transparency, traceability, and patient safety. For medical device manufacturers, UDI is becoming a key component of regulatory compliance.

For those manufacturing beyond the European market, it is highly beneficial to adopt an internationally oriented UDI strategy from the outset. This approach allows companies to position themselves strategically, accelerate market access, and reduce regulatory risks.

EUDAMED as a Starting Point

Under the MDR, medical device manufacturers are required to register UDIs in EUDAMED. This includes labeling on the product, packaging, or directly on the device, as well as entering product data into the European database. UDI is therefore a central element of the MDR, supporting improved market surveillance and product safety through standardized identification.

For manufacturers who have not yet integrated UDI into their processes, EUDAMED offers an ideal starting point for developing a future-proof, international UDI strategy. As one of the most comprehensive UDI systems worldwide, EUDAMED provides a strong blueprint for expanding to other systems, such as those in Australia, Switzerland, the UK, or India.

Recommended Steps for Building a UDI Strategy

Every UDI strategy – whether international or market-specific – should include the following core elements:

• Consistent data maintenance
• Simple updates within internal systems and with authorities
• Reliable data quality

To achieve these goals, the strategy should focus on data collection, validation, automation, and transparency. Depending on the volume and complexity of the data, partnering with a suitable software provider may also be beneficial.

Automating UDI processes reduces errors and saves significant time compared to manual workflows. It also supports a critical component: complete documentation and traceability of all UDI-related decisions and activities. A well-designed automation strategy not only ensures regulatory compliance but also provides a robust foundation for international scalability. It enables companies to respond flexibly to new market requirements and continuously evolve their UDI strategy.

Key Recommendations at a Glance

• Establish a centralized data management system
• Integrate UDI processes into existing systems (e.g., PLM, ERP)
• Involve Regulatory Affairs, IT, Quality, and Product Management early on
• Use EUDAMED as a “pilot” for global UDI implementation
• Choose partners/service providers that cover additional regulatory requirements
• Conduct training and awareness campaigns on UDI processes within the organization

Lack of Harmonization as a Challenge

Developing a unified strategy is complex due to the varying UDI requirements across countries and regions. Differences in data formats, timelines, and classifications make consistent implementation difficult.

Depending on current and future target markets beyond the EU, companies must consider the respective national UDI systems. To ensure long-term viability, international standards such as the IMDRF UDI Guidance can be used as a framework.

Planning for Adjustments

The EU is planning simplifications and new guidelines, for example, for electronic instructions for use (eIFU) and breakthrough technologies. This indicates a move toward easing implementation and potentially harmonizing with other UDI regulations. At the same time, it highlights the importance of a long-term strategy, as companies will need to adapt to ongoing changes.

Despite the effort required for compliance, the goals and benefits are clear: improved traceability and patient safety, faster response times in case of recalls or safety notices, and a competitive advantage through higher data quality and market transparency. A comprehensive (international) UDI strategy supports all these objectives and facilitates implementation for manufacturers.