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  • 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

    Available format(s):  Hardcopy

    Language(s):  English

    Published date:  01-05-2015

    Publisher:  European Union

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Development Note Available for free download. (01/2017)
    Document Type Standard
    Publisher European Union
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

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