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MEDDEV 2.7-3 : REV 3 : 2015

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

05-01-2015

Publisher

European Union

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

EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)

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Hardcopy - English
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