The updated ISO 14155:2026 standard for clinical investigations has now been published.
While authorities recommend using the latest version, there are a few important considerations:
• The new version is not yet harmonized with MDR
• Sponsors must ensure full compliance with MDR requirements
• MDR takes precedence if differences arise
Both the 2020 and 2026 versions are currently accepted, but careful assessment is essential when transitioning. Find out more about the updated ISO 14155:2016 standard.
Our team of experts at Aurevia can support sponsors in interpreting these changes and ensuring practical alignment between standards and regulatory expectations.
Contact us to discuss your needs or learn more about our services for quality, regulatory and clinical investigations.
