ISO 14155:2026 updates the international framework for medical device clinical investigations, strengthening expectations for ethics, risk management, governance, and scientific rigor. This article outlines the key changes introduced in the new revision and highlights their practical and regulatory implications under the EU MDR.

An overview of how the 2024 Declaration of Helsinki’s ethical principles were translated into the 2025 GCP E6(R3): what this means in practice for Sponsors and medical device Manufacturers.