Ex 124 - Understanding the European Directive 93/42/EEC concerning Medical Devices
Overview
To provide a detailed overview of the Directive and later changes and the relevance to Medical Device Manufacturers. This Directive provides the "rules of the game" in manufacturing CE marked medical devices and it is important that these are understood by all Medical Device Manufacturers, Regulatory Bodies and their roles are defined in the Directive, together with classification criteria and the routes to the EC Declaration of Conformity and the use of the CE mark.
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
- Understanding 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 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
