Title of Course: Regulatory Affairs
Exam number: XM 1320
Length of course: 2 hours per week
Type of course: lecture
Language: English
Lecturer: Prof. Dr. Erik Schwanbom
Aim of course: To give an in-depth knowledge how to comply with International and European regulations and legal requirements concerning design, development, manufacturing, placing on the market and use of medical devices
Necessary prerequisite: Completed courses in medical technology, basic knowledge of quality management
Recommended Literature:

• European Directives on Medical Devices
• EN 1441 "Medical Devices - Risk Analysis"
• EN ISO 14971 Medical devices - Application of risk management to medical devices
• Collation of relevant EU- and GHTF- Documents as applicable
• ISO 10993-1 Biological evaluation of medical devices
  

Content:

• The lectures start with an overview of the European Directives and their legal position with respect to national and international regulations.
• The Medical Device Directives are analysed with respect to notification of manufacturer, borderline issues, standards, classification, conformity assessment procedures, use of harmonised standards, clinical evaluation including clinical investigation and incident reporting. Parallels and differences to FDA 510k and PMA-procedures are outlined.
• The Essential requirements of the Directives are explained and methods to demonstrate compliance with them are described.
• Requirements concerning documentation of design as well as establishing and implementation of risk management during the life cycle of the device are analysed and explained.
• Safety concepts including methods for risk/benefit analysis (as part of clinical evaluation) are described including exercises on how to conduct a risk analysis.

German regulations concerning manufacturer and user responsibilities with regard to the use of devices in health care facilities are outlined.

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