User contributions for Gxplex admin

29 June 2026

• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a) 1 revision imported
• 15:0715:07, 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
• 15:0715:07, 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
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) II 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) I 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:EUR European Bioethics Convention 1997 - 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP) 1 revision imported
• 15:0715:07, 29 June 2026 diff hist 0 m Reference:WMA Declaration of Helsinki 2024 - 1 revision imported