Back to all regulations
EN ISO 15194in-force

EN ISO 15194:2009 — In vitro diagnostic medical devices - Certified reference materials and supporting documentation

EN ISO 15194:2009

Applies from 2011-01-01

Summary

EU harmonised standard EN ISO 15194:2009: In vitro diagnostic medical devices - Certified reference materials and supporting documentation.

Scope

IVDR (Regulation (EU) 2017/746) / MDD harmonised standard — In vitro diagnostic medical devices - Certified reference materials and supporting documentation.

Expert analysis

Save

Our 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.