In April 2020, the voting on the third edition of ISO 14155 took place, and the new revision is currently being finalized. This version of the international standard for clinical investigation of medical devices for human subjects will replace the 2011 edition.
Compared to the 2011 edition, the 2020 edition will include newly added guidance on various items, including but not limited to the following:
- Risk-based and centralized monitoring
- Clinical investigation audits
- Responsibilities of ethics committees
- Clinical quality management
- Statistical considerations
Further updates that are addressed in the 2020 edition include the following:
- The importance of risk management in regard to the total clinical investigation process is reinforced, from clinical investigation planning up to the consideration of results.
- Guidance sections are earmarked for different clinical development stages, such as explaining that certain sections would not be applicable for clinical investigations in the post-market phase. This corresponds well with the increasing overall focus on post-market data collection (e.g., the life-cycle approach of the European MDR).
- The assessment of “safety and performance” of medical devices in a clinical investigation setting is updated into the assessment of “performance or effectiveness and safety.”
- The requirement for registering the clinical investigations on medical devices in a publicly accessible database, as well as the need to update this registration during the clinical investigation and after study end, inclusive of the final study results.
We at Avania are working on the updates to ensure that our support and services provided are aligned with the requirements set forth in ISO 14155:2020 once this third edition is final.