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Glossary:TAG-00201-Cli-eSt

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Glossary > Clinical investigation

Clinical investigation
Tag-ID TAG-00201-Cli-eSt
English Clinical investigation / Clinical study / Device clinical trial
EN Abbr. CI
French Investigation clinique / Étude clinique sur un dispositif
German Klinische Prüfung / Klinische Studie / Klinische Untersuchung
DE Abbr. KP

References

 ScopeDocument partLanguageDocument
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4MD§ 3 Absatz 4DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31MD§ 31DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33MD§ 33DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 38MD§ 38DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 39MD§ 39DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001MD§ 47DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-002MD§ 47DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48MD§ 48DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 49MD§ 49DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 50MD§ 50DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 53MD§ 53DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54MD§ 54DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble PreambleMDPreambleENEU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2MDAnnex XV

Chapter I

Section 2		ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7MDAnnex XV

Chapter II

Section 1.7		ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002MDArticle 109 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45MDArticle 2 Paragraph 45ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
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
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1MDArticle 62 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3MDArticle 62 Paragraph 3ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4MDArticle 62 Paragraph 3 & 4ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4MDArticle 62 Paragraph 4ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j)MDArticle 62

Paragraph 4

(j)		ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1MDArticle 70 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7MDArticle 70 Paragraph 6 – 7ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72MDArticle 72ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 3 – 4-002MDArticle 72 Paragraph 3 – 4ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5MDArticle 72 Pragraph 5ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 73MDArticle 73ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74MDArticle 74ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75MDArticle 75ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76 Paragraph 3MDArticle 76 Paragraph 3ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 4 – 5MDArticle 77 Paragraph 4 – 5ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77 Paragraph 5MDArticle 77 Paragraph 5ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4MDArticle 80 Paragraph 4ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82MDArticle 82ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 1.12IVDAnnex XIV

Chapter II

Section 1.12		ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1MDANNEX X 2.1ENGBR Directive 93/42/EEC 11-Oct-2007
GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2.MDAnnex VIII 1. ; 2.ENGBR Directive 93/42/EEC 11-Oct-2007
GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2MDAnnex X 2.2ENGBR Directive 93/42/EEC 11-Oct-2007
GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7MDAnnex X 2.3.7ENGBR Directive 93/42/EEC 11-Oct-2007
GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4.MDArticle 15 1. - 4.ENGBR Directive 93/42/EEC 11-Oct-2007
GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001MDArticle 15 6. - 7.ENGBR Directive 93/42/EEC 11-Oct-2007
GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002MDArticle 15 6. - 7.ENGBR Directive 93/42/EEC 11-Oct-2007
GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3)MDArticle 16 (1) - (3)ENGBR The Medical Devices Regulations 2002 11-Feb-2021
ICH ICH E11 Guideline R1 (2017) -G-ENICH ICH E11 Guideline R1 (2017)
ICH ICH E8 Guideline R1 (2021) 4.3.3.1HM4.3.3.1ENICH ICH E8 Guideline R1 (2021)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.42 - recruitmentMD3.42 - recruitmentENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.47MD3.47ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8MD3.8ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7MD5.7ENISO 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 7.5.3MD7.5.3ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - CIPMDAnnex A - CIPENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex DMDAnnex DENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-001MDAnnex EENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex E-002MDAnnex EENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex IMDAnnex IENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3MDAnnex I 6.3ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex JMDAnnex JENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.21HM§ 312.21ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigationHM§ 312.3 - Clinical investigationENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c)G§ 50.3 (c)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m)G§ 56.102 (m)ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.1MD§ 812.1ENUSA 21 CFR Part 812 09-Apr-2025
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 -MD-ENUSA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018
USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 -G-ENUSA Recognized Consensus Standards - ISO 14155 21-Dec-2020
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