| • Differentiate between non-medical devices, medical devices and combination products. (k1-k5)
• Classify medical devices and combination products according to MDR. (k1-k5)
• Develop and present classifications in teams. (k1-k5)
• Differentiate the MDR guidelines by region. (k1-k3)
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• History, definition(s) and differentiation of medical devices in relation to other products (e.g. medical devices and cosmetics)
• Current status of medical devices and their legal framework
• Development of a medical device for the European market
• Placing a medical device on the market in Austria/European Union
• Life cycle management of medical devices
• Responsibilities of economic operators (legal manufacturer, importers, etc.)
• Interactive working session: Classification of medical devices in the European Union
• Legal basis
• Austrian MPG 2021 (‘Medical Devices Act 2021’)
• Regulation (EU) 2017/746 and Regulation (EU) 2017/74
• SO 13485: Medical devices - Quality management systems Requirements for regulatory purposes
• 21 CFR PART 820 - Quality System Regulation (FDA)
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