| | Scope | Document part | Language | Document |
|---|
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a Absatz 3 | HM | § 40a
Absatz 3 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002 | HM | § 40b
Absatz 6 | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002 | HM | § 40b | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001 | HM | § 40d | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002 | HM | § 40d | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003 | HM | § 40d | DE | DEU AMG - Arzneimittelgesetz 19-Jul-2023 |
| DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3 | NIS | 3.3 | DE | DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III 2. ; 7. | MD | Annex XV
Chapter III
2. ; 7. | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex XV Chapter III Section 4 | MD | Annex XV
Chapter III
Section 4 | 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 | MD | Article 72 | 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 2 | MD | Article 72
Pragraph 2 | 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 Annex XIV Chapter II Section 2 | IVD | Annex XIV
Chapter II
Section 2 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Annex XIV Chapter II Section 4 | IVD | Annex XIV
Chapter II
Section 4 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 | IVD | Article 68 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 1 | IVD | Article 68
Paragraph 1 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 68 Paragraph 2 | IVD | Article 68
Paragraph 2 | 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 48 | HM | Article 48 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (6) - (11) | HM | Article 3
(6) - (11) | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 3 | G | III. Annex 1
3 | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9 | MD | 9 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 9.2.5 | MD | 9.2.5 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.50 | HM | § 312.50 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.52 | HM | § 312.52 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.53 | HM | § 312.53 | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b) | HM | § 312.53
(b) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.53 (d) | HM | § 312.53
(d) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.40 | MD | § 812.40 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.43 | MD | § 812.43 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (5) | MD | § 812.43
(c) (5) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.45 | MD | § 812.45 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.46 (a) | MD | § 812.46
(a) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 1.4 | G | 1.4 | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4 | HM | 10.4 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5 | HM | 5 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.12 | HM | 5.12 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.14 | HM | 5.14 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
