The Emerging Regulatory and Standardization Framework Supporting Medical Device/IVD Digital Labeling

Digital labeling for medical devices and in vitro diagnostics (IVDs) is entering a new phase—one shaped by increased collaboration across industry, regulators, and standards organizations.

A major initiative under the European Innovative Health Initiative (IHI), the MedTechLabel project, is bringing together a diverse group of stakeholders to develop a more unified and scalable framework for digital labeling. With participation spanning industry leaders, notified bodies, standards development organizations, and health authorities, this work signals a meaningful step toward greater alignment in how product information is delivered and maintained.

In this Let’s Talk session, we’ll explore the emerging foundations of this framework and what it may mean for regulatory and labeling teams as expectations around digital product information continue to evolve.

While much of this work is still in progress, staying close to these developments is critical for organizations preparing for the next wave of labeling transformation.

What You'll Learn

• How global initiatives like MedTechLabel are beginning to shape a more unified approach to medical device and IVD digital labeling
• What early standardization efforts could mean for regulatory alignment, scalability, and labeling operations
• Why digital labeling is gaining momentum—and how organizations can stay aligned as frameworks continue to evolve

Who Should Attend

This session is designed for professionals involved in labeling, regulatory strategy, and digital transformation within medical device and IVD organizations, including:

• Regulatory Affairs leaders and team members
• Labeling and UDI professionals
• Quality and Compliance stakeholders
• Packaging and labeling operations teams
• Digital transformation and product information management leaders

Speaker

• Roger Peterson, Sr Manager Global Labeling - Regulatory MsC, Arthrex