| | Scope | Document part | Language | Document |
|---|
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63 | MD | § 63 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 | MD | § 64 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 3 | MD | Article 80
Paragraph 3 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 80 Paragraph 4 | MD | Article 80
Paragraph 4 | 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 76 Paragraph 2 – 3 | IVD | Article 76
Paragraph 2 – 3 | 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 76 Paragraph 4 | IVD | Article 76
Paragraph 4 | EN | EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 ANNEX I Section D No. 19 | HM | ANNEX I
Section D
No. 19 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 2 Paragraph 2 No. 32-34 | HM | Article 2
Paragraph 2
No. 32-34 | EN | EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 |
| FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-001 | MD | 2. | FR | FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 |
| FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 2.-002 | MD | 2. | FR | FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 |
| GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-001 | MD | 2. | EN | GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 |
| GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 2.-002 | MD | 2. | EN | GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 16 | HM | Article 16 | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (o) | HM | Article 2
(o) | EN | GBR Directive 2001/20/EC 04-Apr-2001 |
| GBR Directive 93/42/EEC 11-Oct-2007 Annex X | MD | Annex X | EN | GBR Directive 93/42/EEC 11-Oct-2007 |
| GBR MEDDEV 2.7/3 revision 3 May-2015 4 | MD | 4 | EN | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| GBR MEDDEV 2.7/3 revision 3 May-2015 5 - 6 | MD | 5 - 6 | EN | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| GBR MEDDEV 2.7/3 revision 3 May-2015 7.1 | MD | 7.1 | EN | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 serious adverse event | HM | Article 2
serious adverse event | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 32 | HM | Article 32 | EN | GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 |
| ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction | G | II B.
Serious Adverse Event or Adverse Drug Reaction | EN | ICH ICH E2A Guideline 1994 |
| ICH ICH E2A Guideline 1994 II B. Serious/Severe | G | II B.
Serious/Severe | EN | ICH ICH E2A Guideline 1994 |
| ICH ICH E2A Guideline 1994 III A. 2. | G | III A. 2. | EN | ICH ICH E2A Guideline 1994 |
| ICH ICH E6 Guideline R3 (2025) GLOSSARY - Serious Adverse Event (SAE) | G | GLOSSARY - Serious Adverse Event (SAE) | EN | ICH ICH E6 Guideline R3 (2025) |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.45 | MD | 3.45 | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.32 - SAE | HM | § 312.32 - SAE | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA 21 CFR Part 312 09-Apr-2025 § 312.64 (b) | HM | § 312.64
(b) | EN | USA 21 CFR Part 312 09-Apr-2025 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.21. | G | 2.1.21. | EN | USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 |
| USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 2.1.28 | G | 2.1.28 | 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 4.10 | HM | 4.10 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.13 | HM | 5.13 | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.2 - Investigator | HM | 7.2 - Investigator | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
| WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - serious adverse event | HM | Glossary - serious adverse event | EN | WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 |
