What is the role of the Notified Body (NB) when a Class I sterile device needs a labeling update?

The role of the Notified Body (NB) in the context of a labeling update for a Class I sterile device is primarily centered around ensuring that the sterilization process complies with regulatory standards. This is critical because the classification of the device as sterile hinges on the effectiveness and appropriateness of the sterilization methods used.

When a Class I sterile device undergoes changes that might affect its safety or performance, such as modifications to the labeling that could imply alterations to the sterilization method or instructions, the Notified Body is tasked with evaluating these processes. Their involvement ensures that any updates to labeling that impact the sterilization process meet the necessary regulatory requirements before a product can be marketed.

In contrast, other options such as issuing an EC-type examination certificate or reviewing the updated labeling do not align with the standard role of the Notified Body for Class I devices, as these functions are typically reserved for higher-risk classifications. Similarly, stating that the NB is not involved does not accurately reflect their responsibilities concerning Class I sterile devices, particularly when safety and efficacy are at stake.