V5 Ultimate
Compliance

IMDRF Essential Principles

essential principles of safety and performance · ep

TL;DR

Globally harmonised safety and performance requirements every medical device must meet, mapped to standards as the technical evidence.

The IMDRF Essential Principles of Safety and Performance define the high-level safety/performance requirements every device must meet, regardless of jurisdiction. Manufacturers map each principle to recognised consensus standards (ISO 13485, ISO 14971, IEC 60601, etc.) inside the technical file / 510(k) submission.

V5 maintains the EP-to-evidence map alongside design controls so every submission shows the same chain from principle to test report.

Regulatory anchors
  • IMDRF GRRP WG/N47
  • EU MDR Annex I
  • 21 CFR 820
Industries that live with this
Medical Devices
How V5 handles it
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
Technical FileEU MDR
Software that covers IMDRF Essential Principles
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