User contributions for Gxplex admin

29 June 2026

• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-002 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 109 Paragraph 1-001 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 17 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex J 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:IMDRF IMDRF – Guidelines - - 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Audit 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.31 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 24 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 22-23 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:AUT BASG - FAQ 11-Feb-2025 Änderung am Personal 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3) 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 42 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 71 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 75 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 24 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 3-6 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 23 Paragraph 1-2 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 22 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 21 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 4-7 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 20 Paragraph 1-3 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 2-4 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 19 Paragraph 1 1 revision imported
• 14:5214:52, 29 June 2026 diff hist 0 m Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 18 Paragraph 1-3 1 revision imported