Delivered in-house, this 1-day practical workshop provides an awareness of the European Directive 93/42/EEC concerning Medical Devices. Knowledge of its contents is vital to seeing the relevance of the requirements placed on manufacturers, particularly the relevance of ISO 13485:2012, the quality standard for the medical device industry.
This workshop will develop knowledge of the Articles and Annexes of the Directive and points the way to other sources of documentation. It provides a detailed overview of the Directive and the relevance of the Directive to Medical Device manufacturers in manufacturing CE marked medical devices. Regulatory Bodies and their roles are defined in the directive, together with classification criteria and the routes to EC Declaration of Conformity and the use of the CE Mark
- Expectations of the EU in applying risk analysis to medical devices
- Scope of the European Directive 93/42/EEC, its 22 articles and 12 annexes
- The roles of the bodies defined in the Directive, particularly the MHRA
- The allowed paths to be able to use a Declaration of conformity and the CE mark
- The Essential Requirements and the role of risk assessment
- Incident reporting requirements and the role of post production surveillance
- Classification criteria and clinical evaluation requirements
- Sources of information and further guidance
- General Managers / Business Unit Managers
- Quality and Regulatory Professionals
- Management representatives / Internal and External Auditors
- Those seeking an understanding of the Directive
By the end of this training course, delegates will be able to:
- Apply the articles of the European Directive 93/42/EEC and follow the acceptable paths to enable the use of a Declaration of Conformity and the CE Mark.
- Apply risk evaluation and risk control principles to their devices which affect decision making on the acceptability of risks in bringing a device to market.
Course Delivery
This course is available on an In-house Training basis. For a free quotation please contact us or call the Training Team on 0333 123 9001.