Justification of use of non-harmonized standards for MDR conformity

Ronen E

Problem Solver
Moderator
The justification is not GSPR-specific. The way I did it, it was a separate section at the beginning of the GSPR checklist. Then each GSPR made a reference to the relevant standard(s) in the list.
 

planB

Super Moderator
Here is what BSI says in one of their whitepapers on p. 10 - quote:

The manufacturer also needs to be able to demonstrate how they have ‘taken into account’ the state of the art. This suggests that manufacturers should be aware of, and consider, the latest version of a relevant standard, even if it is not yet cited in the Official Journal.
 
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