The ISO 14155 standard was released on February 1, 2011 by the the International Organization for Standardization (ISO). This affects all medical device manufacturers and is now the standard of reference for conducting medical device clinical studies in the United States, Japan and other countries.
It is important for Medical Device Manufacturers to use this standard to demonstrate compliance with EU requirements for clinical investigations detailed in the medical device directives. ISO 14155:2011 is a single document (the former standard was divided into two parts) and is twice as long as the previous version. The document now includes nine clauses (instead of 15 in the previous version) and eight annexes instead of four in the 2003 version. Worthy of note is also the fact that new requirements have been added to the standard: they deal for the most part with sponsor responsibilities, informed consent for vulnerable subjects, Ethics Committees, study monitoring, electronic data management and risk management.
As part of
Important updates are being finalized including reinforcement of risk management throughout all aspects of a medical device clinical investigation, risk-based monitoring, guidance on
Some changes in the document are also triggered by the new regulations and guidance documents that were published in Europe and the US, as the main goal of the working group is to ensure the document keeps its global acceptance level.
The presentation will provide a comprehensive overview of the important upcoming changes in the document which will most likely become into force towards the end of 2018 early 2019. This is an excellent opportunity for medical device clinical professionals to keep up to date and be prepared.
Key changes in the third edition of ISO 14155
- The third edition of the ISO 14155 standard for medical device clinical investigations is expected in 2019.
- Broader risk management requirements are a key feature of the revised ISO 14155.
- Final publication of ISO 14155’s third edition will likely occur in mid-2019.
Revisions to the ISO 14155 standard covering pre- and post-market clinical investigations for medical devices are set to take effect in 2019. Manufacturers and clinical trial sponsors should consider ramifications of the updated standard for risk management and related issues if they have not already begun doing so.
According to the International Organization for Standards (ISO) the upcoming third edition of the ISO 14155 standard for clinical investigations and Good Clinical Practice (GCP) includes a more explicit and thorough application of risk management across all phases of the clinical investigation process.
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; defined sponsor and clinical investigator responsibilities; and supporting medical device conformity assessment efforts by sponsors, investigators, regulators, and other stakeholders.
More robust and comprehensive risk management requirements are a key feature of ISO 14155’s latest edition. The third edition more closely ties medical device risk management principles covered by the ISO 14971 standard and other sources to clinical-investigation processes, and requires
Additional changes included in ISO 14155’s third edition include:
- Summary of GCP principles
- Guidance on clinical quality management, clinical investigation audits and ethics committees
- Risk-based monitoring requirements
- Registration of clinical investigations in publicly accessible databases
- Clarifications on how ISO 14155 requirements apply to each stage of clinical development
- Annexes relating ISO 14155 to the European Medical Devices Regulation, and to the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD).