VIDEO: The Notified Body Mistake That Can Delay Combination Products
One of the most common combination-product mistakes is treating notified-body review as a final checkpoint before submission.
In practice, notified bodies may expect a detailed and traceable device-development story. That includes the rationale behind design decisions, identified risks, risk controls, verification and validation evidence, and the connections between requirements and supporting documentation.
In this clip, Susanne Weps explains why notified-body engagement needs to be early and structured, particularly for pharmaceutical teams that are more familiar with medicinal-product pathways. She also discusses how expectations can vary and why a device that works is not, by itself, enough.
Early preparation can help teams identify documentation or evidence gaps before they affect submission timelines.
To watch the full discussion click HERE.
To discuss notified-body readiness, EU MDR, or Article 117, contact NSF Life Sciences at lifesciences@nsf.org.
