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  • MEDDEV 2.12-2 : REV 2012

    Current The latest, up-to-date edition.

    POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

    Available format(s):  Hardcopy

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  European Union

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

    1. Introduction
    2. Scope
    3. References
    4. Definitions
    5. Circumstances where a post market clinical follow
       up study in indicated
    6. Elements of a post-market clinical follow up study
    7. The use of study data
    8. The role of the notified body in post-market clinical
       follow up

    Abstract - (Show below) - (Hide below)

    Gives guidance on the appropriate use and conduct of PMCF studies to address issues linked to residual risks.

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

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

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

    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    MEDDEV 2.7-1 : REV 4 2016 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC
    AAMI ISO 14155 : 2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
    14/30302761 DC : 0 BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS)
    MEDDEV 2.7-4:2010 GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    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
    BIP 0113 : 2012 GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155
    ISO 11249:2018 Copper-bearing intrauterine contraceptive devices — Guidance on the design, execution, analysis and interpretation of clinical studies

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

    MEDDEV 2.7-1 : REV 4 2016 CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC AND 90/385/EEC
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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