Summary of the initiative

This Code of Business Practice is intended to provide guidance as to the minimum standards which should apply to its members' business practices in Europe and, generally, elsewhere. Minimum standards on the production and supply of quality medical devices and related services in the interest of patient safety and well-being.

Description of the Initiative



    Contact Point - Commission
    SANCO C.5.

    Self/Co-Regulation Basic Act

    Title of Act
    Eucomed, Code of business practice

    Geographical Coverage

    Participating Countries


    Problems that lead to the introduction of Self/Co-Regulation and the adoption of the Founding Act
    Target Group(s)
    National and corporate members of Eucomed.
    Type of Instrument(s)
    Code of Practice.
    Type of Monitoring
    Conduct an initial survey of compliance capacity of future regulateesConduct regular visits and spot checksInitiate complaints proceduresMaintain database of those bounded by the normsProduce regular reportsReceive complaints and verify if norms were breached or notReflexive dialogue with the - stakeholdersOther
    European Commission
    National public authority
    International public authority
    Private regulator (code owner)yes
    Private independent party with a mandate (e.g. auditors)
    Self-appointed private parties (e.g. NGOs)
    Succinct description of the type of Monitoring
    Members are obliged to take measures to ensure compliance with the principles of the Code by their employees, agents and representatives. Members should adopt effective compliance programmes by issuing written policies and procedures.
    Type of Enforcement
    Faming, shaming and blamingJudicial sanctionsMembership suspension/exclusionPrivate finesOther
    Private Regulatoryes
    Private independent party with a mandate (e.g. auditors)
    Court system
    Alternative dispute resolution (ADR) / Online dispute resolution (ODR)
    Succinct description of the type of Enforcement


    SMO self- and co-regulation database - private code 128