ISO 14155 UPDATE IN 2019


ISO 14155 UPDATE IN 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019.

In general, ISO 14155 continues to cover general requirements intended to:

  • Protect the rights and safety of human subjects;
  • Ensure scientific conduct of clinical investigations and credibility of results;
  • Define sponsor and clinical investigator responsibilities;
  • Support medical device conformity assessment efforts by sponsors, investigators, regulators and other stakeholders.

The main change of the new edition of ISO 14155 regards a reinforcement of risk management across all phases of the clinical investigation process. In fact, the updated ISO 14155 requires that the principles of medical device risk management required by the ISO 14791 standard be applied to all components of clinical investigations.

Other changes expected in the third edition of ISO 14155 are the following:

  • Inclusion of a summary of GCP principles;
  • Inclusion of guidance on clinical quality management, clinical investigation audits, statistical considerations;
  • Inclusion of guidance for ethics committees;
  • Inclusion of Risk-based monitoring requirements;
  • Reference to registration of clinical investigations in publicly accessible databases,
  • Clarifications on how ISO 14155 requirements apply to each stage of clinical development;
  • Inclusion of annexes relating ISO 14155 to the European Medical Devices Regulation, and to the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).

At the moment, the new edition of ISO 14155 is available in a draft version. The final version of the updated standard will be published by Spring 2019.