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• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B. B4  + (1.1.1)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - Clinical Research  + (1.1.1)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.4  + (1.1.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3  + (1.1.1)

• Reference:INT Nuremberg Code 1947 Code  + (1.1.3)
• Reference:WMA Declaration of Helsinki 2024 -  + (1.1.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - Good Clinical Practice (GCP)  + (1.1.3)
• Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 WHO Principles of GCP  + (1.1.3)
• Reference:EUR European Bioethics Convention 1997 -  + (1.1.3)
• Reference:ICH ICH E6 Guideline R3 (2025) I  + (1.1.4)
• Reference:ICH ICH E6 Guideline R3 (2025) II  + (1.1.4)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical Trial  + (1.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial  + (1.2.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8  + (1.2.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - pharmaceutical product  + (1.2.2)
• Reference:WHO WHO - Guidance for best practices for clinical trials 2024 1.1 - NIS  + (1.2.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3  + (1.2.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 1  + (1.2.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 2  + (1.2.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 3  + (1.2.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 4  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 4 – 8  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 14  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 46  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 52  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 45  + (1.2.2)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 62  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 4 – 6  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 7 – 9  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 11  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 14  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 45  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 48  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 42  + (1.2.2)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58  + (1.2.2)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23  + (1.2.2)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34  + (1.2.2)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3  + (1.2.2)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2  + (1.2.2)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001  + (1.2.2)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3  + (1.2.2)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001  + (1.2.2)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2  + (1.2.2)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1  + (1.2.2)
• Reference:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1  + (1.2.2)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 clinical trial  + (1.2.2)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 non-interventional trial  + (1.2.2)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (a)  + (1.2.2)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (c)  + (1.2.2)