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• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 1 – 3  + (1.2.7)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001  + (1.2.7)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 70  + (1.2.7)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4  + (1.2.7)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2  + (1.2.7)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6  + (1.2.7)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1  + (1.2.7)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d)  + (1.2.7)
• Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126  + (1.2.7)
• Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 -  + (1.2.8)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3  + (1.2.8)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7  + (1.2.8)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2  + (1.2.8)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3  + (1.2.8)
• Reference:INT ISPE - GPP Revision 3 (2015) -  + (1.3.0)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001  + (1.3.0)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble  + (1.3.0)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble  + (1.3.0)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6  + (1.3.0)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)  + (1.3.0)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble  + (1.3.0)
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8)  + (1.3.0)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28  + (1.3.0)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2  + (1.3.0)
• Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 -  + (1.3.0)
• Reference:USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 -  + (1.3.0)
• Reference:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 -  + (1.3.0)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements  + (1.3.0)
• Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 15  + (1.3.0)

• Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/A  + (1.4.0)
• Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 89  + (1.4.0)
• Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55  + (1.4.0)
• Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 24  + (1.4.0)
• Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 34  + (1.4.0)
• Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 37  + (1.4.0)
• Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 38  + (1.4.0)
• Reference:FRA Guide de légistique 07-Feb-2024 -  + (1.4.0)
• Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 -  + (1.4.0)

• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities  + (1.5.2)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11  + (1.5.2)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77  + (1.5.2)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85  + (1.5.2)
• Reference:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65  + (1.5.2)
• Reference:FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025 L5311-1  + (1.5.2)
• Reference:USA 21 CFR Part 54 09-Apr-2025 § 54.1-001  + (1.5.2)
• Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC)  + (1.5.3)
• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1  + (1.5.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committee  + (1.5.3)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Introduction  + (1.5.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24  + (1.5.3)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26  + (1.5.3)
• Reference:WMA Declaration of Helsinki 2024 Paragraph 23  + (1.5.3)
• Reference:CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20  + (1.5.3)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41a  + (1.5.3)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41b  + (1.5.3)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41c  + (1.5.3)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4  + (1.5.3)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5  + (1.5.3)
• Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3  + (1.5.3)