Is It a Drug, a Device, or Both?

One of the most important regulatory decisions for any combination product is determining product classification.

For combination products, the answer is not always straightforward. Classification affects everything from development strategy and clinical evidence requirements to regulatory pathways and market access.

In this white paper, our experts explore the key considerations for product classification and provide practical guidance for navigating the regulatory landscape.

What you’ll learn

• How regulators assess PMOA and why it determines the primary regulatory pathway
• The differences between integrated, co-packed and referenced combination products
• How to use a structured PMOA checklist to stress-test your classification strategy
• Common pitfalls that lead to delays, rework and regulatory challenges
• Practical advice for aligning claims, labelling, IFUs and evidence plans