Glossary > Medical device
| Tag-ID
|
TAG-00155-Med-Med
|
| English
|
Medical device / Device
|
| EN Abbr.
|
MD
|
| French
|
Dispositif médical / Dispositif
|
| FR Abbr.
|
DM
|
| German
|
Medizinprodukt / Medizinisches Gerät
|
| DE Abbr.
|
MP
|
References
| | Scope | Document part | Language | Document |
|---|
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 | MD | § 3 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6 | MD | § 6 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85 | MD | § 85 | DE | DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Annex VIII | MD | Annex VIII | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 1 - 3 | MD | Article 2
Paragraph 1 - 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 2 Paragraph 45 | MD | Article 2
Paragraph 45 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 51 | MD | Article 51 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 73 | MD | Article 73 | EN | EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 |
| FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 3. | MD | 3. | FR | FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 |
| FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 - | MD | - | FR | FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025 |
| GBR Directive 93/42/EEC 11-Oct-2007 Article 9 | MD | Article 9 | EN | GBR Directive 93/42/EEC 11-Oct-2007 |
| GBR MEDDEV 2.7/3 revision 3 May-2015 8 | MD | 8 | EN | GBR MEDDEV 2.7/3 revision 3 May-2015 |
| GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 16 (1) - (3) | MD | Article 16
(1) - (3) | EN | GBR The Medical Devices Regulations 2002 11-Feb-2021 |
| GBR The Medical Devices Regulations 2002 11-Feb-2021 Article 2 medical device | MD | Article 2
medical device | EN | GBR The Medical Devices Regulations 2002 11-Feb-2021 |
| IMDRF IMDRF – Guidelines - - | MD | - | EN | IMDRF IMDRF – Guidelines - |
| ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.8 | MD | 3.8 | 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 Annex A - medical device-001 | MD | Annex A - medical device | 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 Annex A - medical device-002 | MD | Annex A - medical device | EN | ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 |
| USA 21 CFR Part 50 09-Apr-2025 § 50.3 (j) | G | § 50.3
(j) | EN | USA 21 CFR Part 50 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.27 | MD | § 812.27 | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (e) | MD | § 812.3
(e) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f) | MD | § 812.3
(f) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA 21 CFR Part 812 09-Apr-2025 § 812.3 (g) | MD | § 812.3
(g) | EN | USA 21 CFR Part 812 09-Apr-2025 |
| USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 510 (k) | G | Sec 510 (k) | EN | USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 |
| USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Sec 512 (f) | G | Sec 512 (f) | EN | USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 |
| USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 Section 513 | MD | Section 513 | EN | USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023 |
| USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 - | G | - | EN | USA Recognized Consensus Standards - ISO 14155 21-Dec-2020 |
| USA U.S. Code Title 21 30-Sep-2023 § 321 (h) | G | § 321 (h) | EN | USA U.S. Code Title 21 30-Sep-2023 |
