Reference:GBR Directive 93/42/EEC 11-Oct-2007 Annex VIII 1. ; 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 1 — Unit 1.5.4 |
| Scope | MD |
| Document part | Annex VIII
1. ; 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Custom-made device, Clinical investigation, Manufacturer, Authorised representative, 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 must draw up the statement containing the information stipulated in Section 2. 2.The statement must contain the following information: […] — the opinion of the ethics committee concerned and details of the aspects covered by its opinion, — the name of the medical practitioner or other authorized person and of the institution responsible for the investigations, [...]
