prEN ISO 18113-1

This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations. This document does not apply to: a) IVD medical devices for performance evaluation (e.g. for investigational use only); b) packaging list; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements).