Clinical Investigation - Related International Standards
The following non-harmonised international standards are related to Clinical Investigation for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 14155:2026 | Clinical investigation of medical devices for human subjects - Good clinical practice | active | 1, 14.2, 14.2.b, 23.4, 23.4.d | Link |
| ISO 20916:2019 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice | active | 1, 6, 8 | Link |