The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.
According to the International Organization for Standards (ISO), the updated edition will focus on a more stringent risk management approach across all stages of clinical investigations from pivotal to Post-Market Clinical Follow-up (PMCF).
The primary change for ISO 14155 will apply the principles of medical device risk management required by the ISO 14791 to all clinical investigations instances.
ISO 14155 General Requirements
On a high level, ISO 14155’s scope continues to cover general requirements pertaining to rights and safety of human subjects; ensuring scientific conduct of clinical investigations and credibility of results; defining sponsor and clinical investigator responsibilities; and supporting medical device conformity assessment efforts by sponsors, investigators, regulators and other stakeholders.
ISO 14155 New Changes
We’ve listed the primary changes below as identified by the ISO:
- Inclusion of a summary section of GCP principles;
- Reference to registration of the clinical investigation in a publicly accessible data base;
- Inclusion of guidance with regards to clinical quality management;
- Inclusion of risk-based monitoring;
- Inclusion of guidance statistical considerations;
- Inclusion of guidance for ethics committees;
- Reinforcement of risk management throughout the process of a clinical investigation (planning to consideration of results);
- Clarification of applicability of the requirements of this standard to the different clinical development stages;
- Inclusion of guidance on clinical investigation audits.
ISO 14155 Implementation Timelines
The third edition of ISO 14155 remains in draft form. Given ongoing evaluations, consultations and comment periods, final publication of the updated standard is not anticipated until spring 2019 at the earliest.
What the ISO 14155 Means for You
Manufacturers must clinically evaluate medical devices before those can be placed on the market in Europe. To do so, you must examine clinical data in order to investigate whether the medical device is safe and performing. To gather credible data during the clinical investigations we must to comply with ISO 14155, the medical device directives and local laws, respectively the upcoming EU Medical Device Regulation.
Do you have a question about ISO 14155 or just want to talk with someone about your clinical investigation or device projects? Contact us.
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Author: Judith Koehnen, Director Project Management Medical Device and Diagnostics