Regulatory Strategy & Market Access | Intended Use & Master UDI-DI

Bringing a medical device to market requires more than achieving regulatory approval. The decisions made early in product development can influence classification, clinical evidence, risk management, labeling, identification, and ultimately the entire market access strategy.

In this Easy Medical Device podcast collection, we focus on two important regulatory topics: defining a proper Intended Use and understanding Master UDI-DI.

Intended Use: The Foundation of Your Regulatory Strategy

Intended Use may look like a simple statement, but it can influence almost every part of a medical device's regulatory pathway.

A poorly defined Intended Use can create downstream problems with device classification, clinical evaluation, risk management, and regulatory submissions.

Even small changes in wording can have significant consequences, particularly for areas such as Software as a Medical Device (SaMD).

The discussion also explores a common misconception: manufacturers cannot simply use a disclaimer or change their labeling to avoid medical device regulation when the actual intended purpose and claims bring the product within the medical device framework.

Understanding Master UDI-DI

Device identification is another increasingly important part of regulatory strategy.

Master UDI-DI introduces an additional layer that MedTech manufacturers need to understand when managing device identification and regulatory information.

Understanding how it fits into the broader UDI framework can help manufacturers prepare their documentation and data strategy while avoiding mistakes that could create additional regulatory or operational work later.

Building a Stronger Market Access Strategy