EN ISO 20916:2024
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
| Status: | Harmonized |
| Poznámka: |
| Full text EAD: | |
| Sector of EN ISO 20916:2024: | IVDR | In vitro diagnostic medical devices (IVDR) |
| Sphere of EN ISO 20916:2024: | Regulation No. 90/2016 - harmonized sphere (NLF) |
| Publications in the Official Journal: |
(EU)2021/1195 (hEN 20. 7. 2021) |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU) 2017/746 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Regulation (EU) 2017/746
consolidated text 9. 7. 2024 pdf format |
Regulation (EU) 2017/746
consolidated text 9. 7. 2024 pdf format
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024) / applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 Act No 375/2022 Sb. applicable from 22. 12. 2022 / amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024 Decree No 377/2022 Sb. applicable from 22. 12. 2022 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
Regulation (EU)2017/746
consolidated text 9. 7. 2024 pdf format
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024) / applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
| Released: | October, 2024 |
ČSN
| ČSN EN ISO 20916:2024 |
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