| | Scope | Document part | Language | Document |
|---|
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 62 Paragraph 4 (j) | MD | Article 62
Paragraph 4
(j) | 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 58 Paragraph 5 (j) | IVD | Article 58
Paragraph 5
(j) | 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 28 Paragraph 1 (f) | HM | Article 28
Paragraph 1
(f) | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 2 7 | HM | Schedule 1
Part 2
7 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-001 | G | III. Annex 1
2.7.1 | EN | ICH ICH E6 Guideline R3 (2025) |
| ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.7.1-002 | G | III. Annex 1
2.7.1 | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 | MD | 10.7 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.25 (e) | G | § 50.25
(e) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.1 | HM | 4.1 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - escape treatment | HM | Glossary - escape treatment | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
