Post-market Surveillance - Related International Standards
The following non-harmonised international standards are related to Post-market Surveillance for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO/TR 20416:2020 | Medical devices - Post-market surveillance for manufacturers | active | 3 | Link |
| ISO 20916:2019 | In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice | active | 1, 3, 6 | Link |
| AAMI TIR73:2019 | Guidance for the application of medical device standards related to complaint handling and the MDR/IVDR vigilance reporting | active | 1, 3 | Link |