Future-Proof Compliance: A Global Perspective on Unique Device Identification

Key Challenges and Success Factors of Complying with Medical Device Regulations for Manufacturers and Labellers

Compliance with UDI regulations requires extensive effort on the part of medical device manufacturers and labelling companies, as they must tackle multiple questions concerning technical implementation aspects, information management, and organizational changes. But what makes compliance even more difficult is the evolving nature of the regulations and lack of standardization between requirements in different countries.

To avoid the hassle of having to modify your system and packaging lines every time regulators adapt the existing requirements, it is crucial to maintain a global overview of the current situation around the world and prepare your systems accordingly. To provide you with a large-scale perspective of the aspects involved in UDI compliance, this white paper explores:

• The current state of the UDI requirements in different countries worldwide
• The main UDI implementation challenges and solutions
• Ways to stay compliant despite evolving requirements
• The role of serialization and traceability in UDI compliance and beyond

We will also address the issue of how to avoid a vendor lock-in situation and choose a solution that ensures compliance with various regulations worldwide, both current and future. Get a copy of our white paper and discover the main challenges and success factors of UDI implementation in today’s globalised economy.