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Glossary:TAG-00202-Inv-Pro

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Glossary > Investigational device

Investigational device
Tag-ID TAG-00202-Inv-Pro
English Investigational device / Device under investigation
French Dispositif faisant l'objet d'une investigation / Dispositif en cours d'investigation
German PrĂźfprodukt / Zu prĂźfendes Produkt / PrĂźfmedizinprodukt

References

 ScopeDocument partLanguageDocument
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46MDArticle 2 Paragraph 46ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.29MD3.29ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3MD6.3ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.9MD7.9ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 812 09-Apr-2025 § 812.110 (c)MD§ 812.110 (c)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2)MD§ 812.140 (a) (2)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g)MD§ 812.3 (g)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (m)MD§ 812.3 (m)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (r)MD§ 812.3 (r)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.36MD§ 812.36ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c)MD§ 812.7 (c)ENUSA 21 CFR Part 812 09-Apr-2025