MEDDEV 2.7-3 : REV 3 : 2015
Current
Current
The latest, up-to-date edition.
CLINICAL INVESTIGATIONS: SERIOUS ADVERSE REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EC
Available format(s)
Hardcopy
Language(s)
English
Published date
01-05-2015
Publisher
Free
Excluding VAT
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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