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Get Proactive and Futureproof Your Medical Device Labeling Process

A practical guide to preparing medical device labels for the next wave of regulations

Medical device labeling has reached a tipping point. The industry is moving away from periodic regulatory updates and into a constant state of regulatory evolution. Over the next few years, manufacturers won’t simply be managing labels. They will be managing a continuous stream of data-driven regulatory requirements that affect every part of the supply chain.

The “next wave” of regulation is not a single deadline. It is a convergence of major changes including EUDAMED activation, the final phases of EU MDR and IVDR, transparency requirements introduced by the EU AI Act, and sustainability mandates such as the Packaging and Packaging Waste Regulation (PPWR).

This shift toward total traceability, digital transparency, and sustainability means that business as usual is becoming a high-risk strategy.

Inside this guide:

• Labels are no longer just packaging artwork. They must serve as a digital twin of global regulatory registrations and product data.

• Labeling remains one of the leading causes of product recalls. With recalls reaching a four-year high in 2024, manual spreadsheet-based processes create significant financial and reputational risk.

• Processes that work for a handful of labels break down when thousands of SKUs require simultaneous updates driven by initiatives like GS1 Sunrise 2027 and global UDI expansion.
• Organizations must adopt a Single Source of Truth and automate artwork generation to push regulatory updates across global portfolios in seconds rather than weeks.
• Companies that adopt end-to-end cloud solutions such as Veraciti™ move from reactive compliance projects to permanent regulatory readiness.
  

Key regulations covered:

• EU MDR and IVDR requirements and the activation of EUDAMED modules
• UDI expansion across global markets
• Electronic Instructions for Use (eIFU) requirements
• The EU AI Act and transparency obligations for AI-enabled devices
• GS1 Sunrise 2027 and the move to 2D barcodes
• Packaging sustainability rules under the EU PPWR
• New battery labeling requirements and the Battery Passport

Learn how to move your medical device labeling operation from a compliance liability to a competitive advantage.

Download A Practical Guide to Preparing Medical Device Labels for the Next Wave of Regulations and discover how leading manufacturers are building scalable, future-ready labeling operations.