Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 2. ; 2.2
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 5 â Unit 5.5.0 |
| Scope | MD |
| Document part | Annex VIII
1. ; 2. ; 2.2 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Insurance, Custom-made device, Clinical investigation, Manufacturer, Medical device |
Content
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 Community] must draw up the statement containing the information stipulated in Section 2. 2.The statement must contain the following information: [...] 2.2.for devices intended for the clinical investigations covered by Annex X: [...] the confirmation of insurance of subjects, [...]
