This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations.
This part of ISO 18113 does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.