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  • The Act On Medical Devices MPG Mindmap EN

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    This document outlines the purpose and scope of the Act on Medical Devices (MPG). It defines key terms and establishes prohibitions to protect patients and users. It also covers requirements for medical devices to be placed on the market, including meeting essential safety requirements and bearing the CE marking. The document is divided into nine parts that address topics such as competent authorities, notified bodies, certificates, and transitional provisions.

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    This document outlines the purpose and scope of the Act on Medical Devices (MPG). It defines key terms and establishes prohibitions to protect patients and users. It also covers requirements for medical devices to be placed on the market, including meeting essential safety requirements and bearing the CE marking. The document is divided into nine parts that address topics such as competent authorities, notified bodies, certificates, and transitional provisions.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    4 views1 page

    The Act On Medical Devices MPG Mindmap EN

    Uploaded by

    sab
    This document outlines the purpose and scope of the Act on Medical Devices (MPG). It defines key terms and establishes prohibitions to protect patients and users. It also covers requirements for medical devices to be placed on the market, including meeting essential safety requirements and bearing the CE marking. The document is divided into nine parts that address topics such as competent authorities, notified bodies, certificates, and transitional provisions.

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    of 1

    § 1 The purpose of the Act

    Part One: § 2 The scope of the Act


    The purpose and scope of the Act,
    definition of terms § 3 Definition of terms

    § 4 Prohibitions to ensure the protection of


    patients, users and other persons

    § 5 Person responsible for the first placing on


    the market

    § 6 Prerequisites for placing on the market


    and putting into service
    § 44 Transitional provisions Part Nine:
    Transitional provisions § 7 Essential requirements

    § 8 Harmonised standards, common


    technical specifications
    § 40 Criminal provisions
    § 9 The CE marking
    § 41 Criminal provisions
    Part Eight: § 10 Prerequisites for the first placing on the
    § 42 Regulatory fining provisions Criminal provisions and regulatory Part Two:
    market and the putting into service of
    fining provisions Requirements for medical devices systems and procedure packs as well as for
    § 43 Confiscation and their operation the sterilisation of medical devices

    § 11 Special regulations regarding placing on


    the market and putting into service
    § 38 Application and enforcement of the Act
    Part Seven:
    § 12 Custom-made devices, medical devices
    § 39 Exceptions Special regulations applying to the manufactured in-house, medical devices in
    Federal Armed Forces tended for clinical investigation, performance
    evaluation or exhibition

    § 13 Classification of medical devices,


    § 32 Tasks and competences of the higher differentiation from other devices
    federal authorities in the field of medical

    The Act on Medical


    devices § 14 Installation, operation, use and
    maintenance of medical devices
    § 33 Database-supported information
    system, European database Devices (MPG)
    § 34 Export § 15 Designation and supervision of bodies,
    approval and subcontracting to testing
    Part Six: laboratories
    § 35 Costs
    Competent authorities,
    § 36 Co-operation between the authorities and ordinances, miscellaneous § 15a Designation and supervision of
    notified bodies in the European Economic Area conformity assessment bodies for third
    provisions countries
    and the European Commission

    § 37 Delegated powers to issue ordinances § 16 Expiry, withdrawal, revocation and


    Part Three: suspension of the designation
    § 37a General administrative ordinances Notified bodies and certificates
    § 17 Duration of the validity of certificates
    issued by notified bodies

    § 18 Restriction, suspension and withdrawal


    § 25 General obligation to notify
    of certificates, notification obligations

    § 26 The conduct of supervision

    § 27 Procedures in the event of the unlawful § 19 Clinical evaluation, performance


    and wrongful affixing of the CE marking evaluation
    Part Five:
    § 28 Procedures for the protection against risks § 20 General prerequisites for clinical
    Supervision and
    investigations
    § 29 Medical Devices Vigilance System protection from risks
    § 21 Special prerequisites for clinical
    § 30 Safety officer for medical devices investigations

    § 31 Medical devices consultant § 22 Procedure regarding the ethics


    committee

    § 22a Authorisation procedure at the


    competent higher federal authority

    Part Four:
    § 22b Withdrawal, revocation and suspension
    Clinical evaluation, performance of the authorisation or of the favourable
    evaluation, clinical investigation, opinion
    performance evaluation studies
    § 22c Changes subsequent to the
    authorisation of a clinical investigation

    § 23 Execution of clinical investigations

    § 23a Announcements regarding completion


    or early termination of clinical investigations

    § 23b Exceptions to the provisions governing


    clinical investigations

    § 24 Performance evaluation studies

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