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EN ISO 13485
8 current listing(s) — 2 EU harmonised, 6 UK designated.
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Current listings
| Edition | List | Title | Presumption from | Withdrawal / cessation | |
|---|---|---|---|---|---|
| EN ISO 13485:2016 | EU IVD Regulation | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) | source | ||
| EN ISO 13485:2016 | EU Medical Devices Regulation | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) | source | ||
| EN ISO 13485:2016 | UK UK IVD (designated) | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 01/01/2021 | 30/09/2021 | source |
| EN ISO 13485:2016 | UK UK IVD (designated) | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 01/01/2021 | 17/01/2026 | source |
| EN ISO 13485:2016 | UK UK IVD (designated) | Medical devices - Quality management systems - Requirements for regulatory purposes | 17/01/2026 | source | |
| EN ISO 13485:2016 | UK UK Medical Devices (designated) | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 01/01/2021 | source | |
| EN ISO 13485:2016 | UK UK Medical Devices (designated) | Medical devices - Quality management systems - Requirements for regulatory purposes | 01/01/2021 | source | |
| EN ISO 13485:2016 | UK UK Medical Devices (designated) | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | 17/01/2026 | source |
Timeline
- 2022-05-12modified in IVD Regulation
EN ISO 13485:2016 - 2022-01-05listed in Medical Devices Regulation
EN ISO 13485:2016
JSON: /api/v1/standard/en-iso-13485.json
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