Document:GBR Directive 93/42/EEC 11-Oct-2007
From GxPlex
| Document information | |
|---|---|
| Reference | GBR Directive 93/42/EEC 11-Oct-2007 |
| Validity area | GBR |
| Scope(s) | MD |
| Document name | Directive 93/42/EEC |
| Version / Revision | 11-Oct-2007 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | COUNCIL DIRECTIVE 93/42/EEC - of 14 June 1993
concerning medical devices |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1 | MD | ANNEX X
2.1 || EN || 2. Clinical investigations 2.1. Objectives The objectives of clinical investigation are: — to verify that, under normal conditions of use, the performance of the devices conform to those referred to ... | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 9 | MD | Article 9 | EN | Classification 1. Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX. 2. In the event of a dispute between the manufacturer and ... |
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. | MD | Annex VIII
1. ; 2. || EN || STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative must draw up the ... | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4. | MD | Article 15
1. - 4. || EN || Clinical investigation 1. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure ... | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X | MD | Annex X | EN | CLINICAL EVALUATION […] 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being ... |
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-001 | MD | Article 15
6. - 7. || EN || Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a ... | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2 | MD | Annex VIII
1. ; 2. ; 2.2 || EN || STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES 1.For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative[F8 established in the ... | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 6. - 7.-002 | MD | Article 15
6. - 7. || EN || Clinical Investigation [...] 6. The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy. Where a clinical investigation is refused or halted by a ... | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.3.7 | MD | Annex X
2.3.7 || EN || 2.3.7. The written report, signed by the medical practitioner or other authorized person responsible, must contain a critical evaluation of all the data collected during the clinical investigation. | ||
| Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex X 2.2 | MD | Annex X
2.2 || EN || 2.2.Ethical considerations Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last ... |
