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List of results

• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product  +
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3  +
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42  +
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3  +
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1  +
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial  +
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial  +
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a)  +
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c)  +
• Reference:GBR The Human Medicines Regulations 2012 01-Jan-2025 Article 51B  +
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1  +
• Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 18  +
• Reference:USA 21 CFR Part 50 09-Apr-2025 § 50.3 (c)  +
• Reference:USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1)  +
• Reference:USA 45 CFR Part 46 09-Apr-2025 § 46.102 (b)  +
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.3 - Clinical investigation  +
• Reference:USA 21 CFR Part 320 09-Apr-2025 § 320.22  +
• Reference:USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 -  +
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.1  +
• Reference:USA NIH - Glossary 27-May-2025 Observational study  +