New: Toy Safety Regulation (EU) 2025/2509 — applies from 1 Aug 2030, with digital product passport obligations.

Read the analysis →
Regulation database
EN ISO 10993-16In force

EN ISO 10993-16:2017 — Biological evaluation of medical devices - Part 16: Toxicokinetic study design

EN ISO 10993-16:2017Applies from 2011-01-01 SaveOfficial source

Summary

EU MDR harmonised standard EN ISO 10993-16:2017: Biological evaluation of medical devices - Part 16: Toxicokinetic study design.

Scope

MDR (Regulation (EU) 2017/745) harmonised standard — Biological evaluation of medical devices - Part 16: Toxicokinetic study design.

Expert analysis

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.