Document:GBR Directive 93/42/EEC 11-Oct-2007: Difference between revisions
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Latest revision as of 14:15, 16 July 2026
| 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
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| 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: β to verify that, under normal conditions of use, the perβ¦ |
| 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 hi⦠|
| 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 hi⦠|
| GBR Directive 93/42/EEC 11-Oct-2007 Annex X | MD | Annex X | EN | CLINICAL EVALUATION
[β¦] 2.3.5.All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member Stβ¦ |
| 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 A⦠|
| 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 da⦠|
| 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 β¦ |
| 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 c⦠|
| 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 c⦠|
| 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 th⦠|
