The edition clock
The edition clock: effective Apr 26, 2026, no transition period — ongoing studies need review now.
Free field guide · PDF
ISO 14155:20262026 Field Guide
The edition clock, the six changes, and the consent bar — with the GCP practice you need.
- Effective
- Apr 26
- Transition
- No
- Changes
- 6
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The six changes
The six changes: risk management, CECs, DMCs, study design & statistics, informed consent, AE reporting.
The consent bar
The consent bar: ample deliberation, plain language, device-specific information, implant-card provisions.
Sources & scope
- clinicaltrialsbc.ca, ISO 14155 Clinical Investigation of Medical Devices for Humans published.
- blog.ansi.org, ISO 14155:2026 — Clinical Investigation of Medical Devices.
- meddeviceguide.com, GCP for Medical Device Clinical Trials (ISO 14155 and ICH E6(R3) in 2026).
This guide is market-access intelligence, not regulatory or legal advice. ISO 14155 interpretation, ethics-committee requirements, and national rules change — professional review is required before business use.
Market Access Strategy Session
Clinical evidence on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your evidence route — investigation strategy, GCP planning, and global evidence positioning.
Professional review is required before business use.
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