User contributions for Gxplex admin

29 June 2026

• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (i) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (f) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.104 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 Article 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 Article 2 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA NIH - Glossary 27-May-2025 Observational study 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a) 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial 1 revision imported
• 15:2815:28, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial 1 revision imported