Changes to ISO 14155 Medical Device GCP



The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable in the clinical research field. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.

One important standard in clinical research is ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice. The latest version of ISO 14155 is the second edition finalized in 2011. But there is a new draft for the third edition and is expected to be released in 2019. The key expected changes will be:

  • Inclusion of a summary of Good Clinical Practice (GCP) principles

  • Guidance for clinical quality management, ethics committees, and audits

  • Addition of risk-based monitoring

  • Strengthened guidance for risk management throughout the clinical investigation

  • Clarification for how the standard is applicable to the different stages of clinical development

  • Discussion of registration of clinical investigations in a public database

ISO 14155 address GCP for medical device studies including the design, conduct, recording, and reporting of clinical investigations. The third edition of ISO 14155 will strengthen risk management requirements across all phases of the clinical investigation process, including pre- and post-market clinical investigations.

Do you currently work on a project where ISO 14155 is applicable?  

- The Clinical Pathways Team

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