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Re: Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14
If your NB won't be practical about the user being a willing and able participant in use-risk management, you could discuss with the NB the possibility that you would cease declaration of conformance to 14971, and instead conform to the Essential Requirements via your own risk procedure that is similar to 14971 except in the areas of present conflict, where your procedure would be based on common real world practice.
If your NB won't be practical about the user being a willing and able participant in use-risk management, you could discuss with the NB the possibility that you would cease declaration of conformance to 14971, and instead conform to the Essential Requirements via your own risk procedure that is similar to 14971 except in the areas of present conflict, where your procedure would be based on common real world practice.