Heerlen, 10 September 2019


Modifications to the ISO 14155 standard covering pre- and post-market Clinical investigations of medical devices for human subjects – Good clinical practice are planned to take effect in the fourth quarter of 2019. Once the third edition takes effect it will replace the second edition (ISO 14155:2011).

The key changes in the third edition of the ISO 14155 are as follows:

  • Inclusion of a summary of GCP principles;
  • References to registration of clinical investigation in a publicly accessible data base;
  • Inclusion of guidance with regards to clinical quality management;
  • Including risk-based monitoring;
  • Inclusion of guidance statistical considerations;
  • Inclusion of guidance for ethics committees;
  • Reinforcement of risk management throughout the process of clinical investigation;
  • Inclusion of guidance on clinical investigation audits.

According to the International Organization for Standards (ISO), the third edition of the ISO 14155 will focus on a more stringent risk management approach across all stages of clinical investigations from pivotal to Post-Market Clinical Follow-up (PMCF).

To date, the third edition of the ISO 14155 remains in draft format. The current progress and stage of the updated standard still indicates an expected publication of the final version later this year (2019).


MedQ Consultants B.V.