MEDDEV 2.7-3 : REV 3 : 2015
Current
The latest, up-to-date edition.
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EC
Hardcopy
English
01-05-2015
1. INTRODUCTION
2. SCOPE
3. DEFINITIONS
4. REPORTABLE EVENTS
5. REPORT BY WHOM
6. REPORT TO WHOM
7. REPORTING TIMELINES
8. CAUSALITY ASSESSMENT
9. REPORTING FORM
Appendix - Summary Reporting Form
The reporting modalities and format set out in this guidance apply to pre-market 2 clinical investigations 3-4 conducted with: a. Non-CE marked devices, b. CE marked devices used outside the intended use(s) covered by the CE- marking.
| DevelopmentNote |
Available for free download. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
12
|
| PublisherName |
European Union
|
| Status |
Current
|
| MEDDEV 2.7-2 : REV 2 | GUIDELINES FOR COMPETENT AUTHORITIES FOR MAKING A VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 90/385/EEC AND 93/42/EC |
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