Title of Course: Regulatory Affairs
Exam number: XM 2610
Length of course: 2 hours per week
Type of course: lecture
Language: English
Lecturer: Prof. Dr. E. Schwanbom
Learning outcomes:
• Knowledge: The relevant legal requirements concerning admission and certification of medical devices in the US and EU, amongst other countries, in addition to the basics in risk management
• Skills: Application of risk management to the production process of a medical device according to standards
Concepts of CE-identification (certification)
• Abilities: Application and implementation of the regular requirements during the processing of medical products (product safety). Dealing with risks in the market (declarations and regulatory actions risks).
Necessary prerequisite:
Basic knowledge in medical technology, application of medical products and quality management.
Content:

• Requirements and procedures concerning CE-marking and quality management system certification according to the EU-Legislation based on New Approach 100a-directives.
• Relevant directives addressing Medical Devices and comparison with US approval schemes.
• Third party inspection/surveillance in EU and corresponding requirements in the USA and other markets.
• Essential Requirements for safety and effectiveness, classification and conformity assessment procedures for medical devices.
• Clinical evaluation and investigation,
• Application of risk management requirements and procedures to medical devices.
• Implementing adverse event reporting, recalls and corrective/preventive actions in post market surveillance systems in the EU and in the USA.
• Technical files and the role and use of Harmonized European standards for the certification and CE-marking. Requirements regarding Instructions for use and marking on the device.
  

Recommended Literature:

• Script, RL 93/42/EG, 21 CFR 803, 806 and 820
  

<< back