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HomeGlossaryIMDRF Essential Principles
Compliance

IMDRF Essential Principles

essential principles of safety and performance · ep

In short

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
Where this term comes up
Medical Devices
How V5 handles it
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Technical FileEU MDR
Software that covers IMDRF Essential Principles
V5 Ultimate Medical Device MES
Device history records built from signed steps at the workstation: component lots, configured step order, inspections, UDI and…
V5 Ultimate (QMSR)
The FDA Quality Management System Regulation (QMSR) — the harmonized replacement for 21 CFR 820 — became effective 2 February…
V5 Ultimate for EU MDR
V5 assembles it as one file that a Notified Body auditor can navigate in an hour.
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