Every time we do a change, we have to evaluate—and you heard this already—whether it's significant or not significant. So you look at the extent of change.
We, as an applicant, have to go to our regulator and say, this is what it is. It's either significant or not significant. Even if it's not significant, we still have to demonstrate compliance with every single requirement. None are left out; it's a product-level evaluation.
Changed product rule requires you to look at later safety requirements in the certification basis. Part of the evaluation will be to look at the extent of the change and determine if there's sufficient change to warrant going to later certification requirements. Certification, no matter what the change, always requires you to look at all the changes and re-evaluate against the certification basis.