Skip to content
Please enter a keyword to search

  • MEDDEV 2.7-4:2010

    Current The latest, up-to-date edition.

    GUIDELINES ON CLINICAL INVESTIGATIONS: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

    Available format(s):  Hardcopy

    Language(s):  English

    Published date:  01-12-2010

    Publisher:  European Union

    Add To Cart

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

    1 Introduction
    2 Scope
    3 References
    4 Definitions
    5 General Principles When Considering the Need
      for a Clinical Investigation
    6 General Principles of Clinical Investigation Design
    7 Ethical Considerations for Clinical Investigations

    Abstract - (Show below) - (Hide below)

    Gives guidance in relation to: - when a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Requirements; and - the general principles of clinical investigations involving medical devices.

    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)

    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
    MEDDEV 2.12-2 : REV 2012 POST MARKET CLINICAL FOLLOW-UP STUDIES - A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
    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 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective