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EN ISO 20916
2 current listing(s) — 1 EU harmonised, 1 UK designated.
Current listings
| Edition | List | Title | Presumption from | Withdrawal / cessation | |
|---|---|---|---|---|---|
| EN ISO 20916:2024 | EU IVD Regulation | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019 | source | ||
| EN ISO 20916:2024 | UK UK IVD (designated) | In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice | 17/01/2026 | source |
Timeline
- 2024-10-09listed in IVD Regulation
EN ISO 20916:2024