ISO 14155:2019 … Changes to Expect

by | Sep 13, 2019 | 510k, FDA, ISO, Medical Devices, Quality Systems, Regulatory

ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name suggests, addresses good clinical practices for all pre- and post-market clinical investigations that determine the safety and performance of medical devices. The final publication of the 3rd edition of ISO 14155 is coming soon in 2019, with some key changes that manufacturers should consider.

Some key changes that will build upon the current edition of 14155:2011 is the inclusion of more vigorous risk management requirements across the whole lifecycle of clinical investigations. ISO 14155:2019 will closely tie risk management practices from ISO 14971 into all required clinical investigation processes. Some other notable changes to the standard in the upcoming 3rd edition include:

  • A summary section of GCP principles
  • Inclusion of guidance for clinical quality management
  • Inclusion of risk-based monitoring
  • Guidance on study design and statistical considerations
  • Increased clarity on how to apply the standard to different clinical development stages
  • Guidance on clinical investigation audits
  • The requirement of specific medical expertise in clinical investigation planning1

Currently, the revision is in the approval phase and being identified as ISO/FDIS 14155 because it is the final draft before publication, which is when it will start being identified as ISO 14155:2019. At this point the revision has been voted on by industry, technical, and regulatory experts and the next steps are approval for publication, which will turn the draft into an international standard.2

Have any questions about clinical investigations for your medical device or need help complying with international standards? Contact us at 248-987-4497 or email:

1ISO (n.d.) ISO/DIS 14155(en) retrieved on 09/10/2019 from

2ISO (n.d.) ISO/FDIS 14155 General Information retrieved on 09/10/2019 from

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