Notified body submission readiness checklist

Before you submit, work through these seven questions. Each one marks a place where notified body queries commonly start. Answering yes to all seven does not guarantee a smooth review, but answering no to any of them tells you exactly where to look first.

1. Safety definitions. Have engineering and regulatory agreed a single definition of harm and hazard, used consistently across the risk file and the technical documentation?

2. Timing of regulatory involvement. Was regulatory input part of design reviews from the start, not added at the end before submission?

3. Traceability. Does every risk control trace forward to verification evidence and back to a stated requirement, with no dangling links?
4. Change control. Is every design change since the last review reflected in the risk file, verification records, and technical documentation, not just the design output?
5. Risk estimation. Is every risk estimate backed by stated evidence, data, testing, or a cited standard, rather than engineering judgement alone?
6. Human factors. Does the use related risk analysis reflect observed use, not just the design team's assumption of intended use?
7. Burden of proof. For every claim in the technical file, is there a specific referenced piece of evidence a reviewer could open directly, without needing it explained?

Answer no to any of these and that is where a notified body query is most likely to land.

If any of these turned up a no, that is worth a conversation before submission rather than during review.