Ex 124 - Understanding the European Directive 93/42/EEC concerning Medical Devices

Overview

The Directive has been in place since the 14th June 1993 and an understanding of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of ISO 13485:2003, the quality standard for the medical device industry. This ONE-DAY workshop provides that full understanding of the Articles and Annexes of the Directive and points the way to other sources of documentation and guidance.

Key Session Topics

• Understand the scope of the Directive
• Understand the 22 articles of the Directive
• Understand the roles of the bodies defined in the Directive, particularly the MHRA
• Understand the 12 annexes of the Directive
• Understand the allowed paths to be able to use a Declaration of conformity and the CE mark
• Understand the Essential Requirements and the role of risk assessment
• Understand the incident reporting requirements and the role of post production surveillance
• Understand the classification criteria
  
• Understand the clinical evaluation requirements
  
• Understand where to find other relevant information and guidance
  

Who Should Attend

• Executives and Senior Management
  
• General Managers / Business Unit Managers
  
• Quality and Regulatory Professionals
  
• Management representatives / Internal and External Auditors
  
• Those seeking an understanding of the Directive