Reference:GBR Directive 93/42/EEC 11-Oct-2007 ANNEX X 2.1
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 | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.2.2 |
| Scope | MD |
| Document part | ANNEX X
2.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical investigation, Objective, Medical device, Performance (device), Risk |
Content
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 in Section 3 of Annex I, and — to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.
