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• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 - by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2. by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E9 Guideline 1998 III by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E8 Guideline R1 (2021) 3.3.5 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E8 Guideline R1 (2021) - by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.85 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.21 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial Phases by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ICH ICH E8 Guideline R1 (2021) ANNEX: TYPES OF CLINICAL STUDIES by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex VIII by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 47 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 737 (8) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 809 06-May-2024 § 809.3 (a) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (h) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (i) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA U.S. Code Title 21 30-Sep-2023 § 321 (f) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.104 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d) by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (k)-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 Article 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 Article 2 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 2 – 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA NIH - Glossary 27-May-2025 Observational study by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.1 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 - by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22 by file upload (1 revision)
• 13:49, 16 July 2026 Gxplex admin talk contribs imported Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation by file upload (1 revision)