Reference:GBR Directive 93/42/EEC 11-Oct-2007 Article 15 1. - 4.
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 | Article 15
1. - 4. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical investigation, Manufacturer responsibilities, Manufacturer, Authorised representative, Competent authority |
Content
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 referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.
2. In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy. Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.
3. In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan
4. The authorization referred to in paragraph 2 second subparagraph and paragraph 3, may be made subject to authorization from the competent authority.
