I just bought 62366-1:2015 and I don't have :2007
A/ Is it a big risk to build my usability file based on this newer one even though it is not yet harmonized? (our product was CE-marked and released years ago so I'm plugging holes in the documentation rather than building an application)
B/
2015 sounds weird to me :
4.1.2 * RISK CONTROL as it relates to USER INTERFACE design
To reduce use-related RISK, the MANUFACTURER shall use one or more of the following options, in the priority listed (as required by ISO 14971:2007, 6.2):
a) inherent SAFETY by design;
b) protective measures in the MEDICAL DEVICE itself or in the manufacturing PROCESS;
c) information for SAFETY.
This is somehow conflicting with the latest updates to 14971 regarding information for safety which cannot be used as a RCM ???