It's irrelevant for cl. 6.6 of ISO 14971 if your product is already on the market. You have to think about the following:
When you specifiy a risk control measure to reduce a risk, does this risk control measure:
When you specifiy a risk control measure to reduce a risk, does this risk control measure:
- lead to any new risks or not? If yes, start with the risk evaluation for this new risk.
- affect any previous risk evaluation results?