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• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 4  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 76 Paragraph 5 – 6  + (5.3.5)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 82 Paragraph 3 – 5  + (5.3.5)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002  + (5.3.6)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003  + (5.3.6)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63  + (5.3.6)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64  + (5.3.6)
• Reference:AUT MPG – Medizinproduktegesetz 26-May-2022 § 22  + (5.3.6)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3.  + (5.3.6)
• Reference:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001  + (5.3.6)
• Reference:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 5.  + (5.3.6)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-46  + (5.3.6)
• Reference:FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 R1123-53  + (5.3.6)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 33  + (5.3.6)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 34  + (5.3.6)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 35  + (5.3.6)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 17  + (5.3.6)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X  + (5.3.6)
• Reference:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002  + (5.3.6)
• Reference:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002  + (5.3.6)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 4  + (5.3.6)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6  + (5.3.6)
• Reference:GBR MEDDEV 2.7/3 revision 3 May-2015 7.1  + (5.3.6)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (b)  + (5.3.6)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (c)  + (5.3.6)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.32 (d)  + (5.3.6)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b)  + (5.3.6)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (b) (5)  + (5.3.6)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (1)  + (5.3.6)
• Reference:USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 Introduction ; III. B. ; Evaluation  + (5.3.6)
• Reference:USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4  + (5.3.6)

• Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002  + (5.4.1)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix A 3.4  + (5.4.1)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001  + (5.4.1)
• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002  + (5.4.1)
• Reference:ICH ICH E9 Guideline 1998 Glossary - Dropout  + (5.4.1)
• Reference:ICH ICH E8 Guideline R1 (2021) 6.2.2  + (5.4.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard  + (5.4.1)
• Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.6  + (5.4.1)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.6.3-002  + (5.4.1)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-001  + (5.4.1)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-001  + (5.4.1)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.30 (b) (ii)  + (5.4.1)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (4)  + (5.4.1)

• Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-002  + (5.4.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.46  + (5.4.2)
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.4.3-002  + (5.4.2)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 54  + (5.4.3)
• Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 77  + (5.4.3)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Paragraph 6  + (5.4.3)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 76  + (5.4.3)
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 77  + (5.4.3)
• Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1  + (5.4.3)
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.46 (b)  + (5.4.3)
• Reference:DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42  + (5.4.3)
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66  + (5.4.3)
• Reference:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11  + (5.4.3)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 30-002  + (5.4.3)
• Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 31  + (5.4.3)
• Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002  + (5.4.3)
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001  + (5.4.3)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.44 (d)  + (5.4.3)
• Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.56  + (5.4.3)