Principles of European Medical Technology Regulatory Affairs

On completion of the three-day course delegates should be able to:

• Critically evaluate the application of legislation and guidelines to specific medical technologies to be marketed within the European Union (EU) and associated territories
• Describe the criteria for classifying different types of medical technology and be able to determine the Conformity Assessment route options for the different classes of technology
• Plan the requirements for a Technical File and a Design Dossier Design a schema for the detailed activities leading to a CE-Mark.

Topics covered by the course include:

• Context and structure of directives with the EU legislative framework
• Roles of European Commission, competent authorities and notified bodies
• Classification of technology and devices including drug/device borderline products
• Conformity assessment routes and the role of quality management systems (ISO 13485) in the CE marking process
• Technical documentation - compilation, content and assessment of compliance with requirements of the directives
• Demonstration of conformity through pre-clinical bench testing and clinical evaluation
• Introduction to the central role of risk assessment in regulatory affairs
• Introduction to other applicable regulations
• Summary of post-market regulatory activities.