TR 151:2026
Clinical investigation of medical devices
OVERVIEW
This Techincal Reference (TR) provides guidance on the application ISO 14155:2026 to clinical investigations of medical devices and reflects related international good clinical practice principles. It provides additional device-specific guidance for the planning, design and conduct of clinical investigations of investigational medical devices.
It further provides guidance on the expected levels of design control, testing, risk management and documentation to be demonstrated at the time of ethics review and approval, taking into account the stage of device development and the risk class of the device. In addition, it provides a reference framework for the review of submissions for such investigations.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2026 |
| No. of Pages | 46 |
| ICS Classification | 11.100.20 Biological evaluation of medical devices |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | - |