| | Scope | Document part | Language | Document |
|---|
| AUT BASG - FAQ 11-Feb-2025 Schwarz | G | Schwarz | DE | AUT BASG - FAQ 11-Feb-2025 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42c | HM | § 42c | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68 | MD | § 68 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77 | MD | § 77 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79 | MD | § 79 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3 | G | 4.3 | EN | EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 |
| EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 5 | G | 5 | EN | EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 ANNEX XV Chapter III, 6 | MD | ANNEX XV
Chapter III, 6 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 72 Pragraph 5 | MD | Article 72
Pragraph 5 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 5 | IVD | Article 68
Paragraph 5 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 78 | HM | Article 78 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (l) | HM | Article 2
(l) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 - | HM | - | EN | GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 |
| GBR MHRA GCP Inspection Dossier template V7.0 - | G | - | EN | GBR MHRA GCP Inspection Dossier template V7.0 |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Inspection | G | GLOSSARY - Inspection | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities | G | GLOSSARY - Regulatory Authorities | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 7.11 | MD | 7.11 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.58 | HM | § 312.58 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.68 | HM | § 312.68 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.145 | MD | § 812.145 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA FDA Information - Observations and citations 20-Mar-2024 - | G | - | EN | USA FDA Information - Observations and citations 20-Mar-2024 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 11.2 | HM | 11.2 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-002 | HM | 4.12 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.12-003 | HM | 4.12 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - inspection | HM | Glossary - inspection | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
