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

Read the analysis →
Regulation database
EN 45502-2-1In force

EN 45502-2-1:2003 — Active implantable medical devices - Part 2-1: Cardiac pacemakers (bradyarrhythmia)

EN 45502-2-1:2003Applies from 2011-01-01 SaveOfficial source

Summary

EU harmonised standard EN 45502-2-1:2003: Active implantable medical devices - Part 2-1: Cardiac pacemakers (bradyarrhythmia).

Scope

IVDR (Regulation (EU) 2017/746) / MDD harmonised standard — Active implantable medical devices - Part 2-1: Cardiac pacemakers (bradyarrhythmia).

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.