Medical Devices: General Rules and Practices

Program

General Introduction to Medical Devices

• Applicable European and Belgian legislation

• Definitions

• Classification

• CE marking

• ISO 13485

• Competent Authorities: how to handle an inspection

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Distribution and export

• Notification of distribution

• Export certificate and application procedure

• Fees and payments

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Good Distribution Practice

• Guideline
   

Workshops

• Exercise 1: Classification of Medical Devices

• Exercise 2: Inspection

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Good Distribution Practices (part II)

• Quality system: minimum requirements

• Practical implementation

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Materiovigilance

• What needs to be notified, by whom and how?

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Electr(on)ic Medical Devices

• Applicable legislation

• Bebat

• Recupel

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