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- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 58 Paragraph 5-001 +
- Reference:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 70 +
- Reference:DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6 +
- Reference:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1 +
- Reference:USA 21 CFR Part 312 09-Apr-2025 § 312.23 (6) (d) +
- Reference:USA 21 CFR Part 314 09-Apr-2025 § 314.126 +
- Reference:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 - +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 9.3 +
- 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) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIII Part A Section 2.3 +
- Reference:INT ISPE - GPP Revision 3 (2015) - +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 47-001 +
- Reference:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble Preamble +
- 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:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble Preamble +
- Reference:EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8) +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 28 +
- Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 +
- Reference:USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 - +
- 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:USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 - +
- Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - 1.5 Regulatory requirements +
- Reference:DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 15 +
- Reference:FRA Infographie - La hiérarchie des normes 22-Mar-2024 N/A +
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 89 +
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 55 +
- Reference:FRA Constitution du 4 octobre 1958 10-Mar-2024 Article 24 +
