EN ISO 15197in-force
EN ISO 15197:2015 — In vitro diagnostic test systems - Blood-glucose monitoring systems for self-testing in managing diabetes mellitus
EN ISO 15197:2015
Applies from 2011-01-01
Summary
EU harmonised standard EN ISO 15197:2015: In vitro diagnostic test systems - Blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Scope
IVDR (Regulation (EU) 2017/746) / MDD harmonised standard — In vitro diagnostic test systems - Blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
Expert analysis
SaveOur compliance experts are preparing a detailed analysis for this regulation. Check back soon.
Want this analysis for your product?
Enter your product features once — ComplyMatrix maps all applicable EU regulations, obligations and testing requirements in minutes.