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Medical devices and their accessories

    • Generalities

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      • Legislation regarding medical devices
      • Presentations
    • Clinical evaluation

      • Studies to notify
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    • Information for the manufacturer

      • Medical devices class IIa, IIb and III
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      • Tailor-made medical devices
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    • Materiovigilance

      • Definition
      • What shall be notified?
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      • When must incidents be notified?
      • How should incidents be notified?
    • Distribution and Export

      • Medical devices
      • Active implantable medical devices (AIMD)
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      • Export certificates and application procedure
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      • Fees based on the turnover made in Belgium and payments

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