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• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 6.3  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I 6.3  +
• 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:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3  +
• 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 812 09-Apr-2025 § 812.1  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A - medical device-001  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3  +
• Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 in vitro diagnostic medical device  +
• Reference:GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6  +
• Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9  +
• Reference:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex I  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 1  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 74  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 82  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 Annex A A.7  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter I Section 2  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble Preamble  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6  +
• Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)  +
• 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 -  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85  +
• Reference:DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24  +
• Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26  +
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f)  +
• Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t)  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 3 & 4  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 1  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 70 Paragraph 6 – 7  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 73  +
• Reference:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter II Section 1.7  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 35  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31  +
• Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33  +