iso13485Understanding the European Directive 93/42/EEC Concerning Medical Devices


Delivered in-house, this interactive and practical workshop is designed to provide an awareness of the Directive. 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.

Course Objectives

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.

Key Skills / Learning Objectives

Through the combination of interactive tutorials, case studies and hypothetical devices or actual company devices, our workshop will enable the delegates to:

  • Apply the articles of the Directive 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 Outline

  • 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

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

Booking and Course Fees

Fees include:

  • Delegate workbook, including reference information
  • Training provided by qualified and experienced tutors with extensive practical management auditing experience across a variety of manufacture and service industries
  • Certificate verifying attendance and completion of course

This course is for delivery in-house only. Offering better value for money, in-house training can be customised and designed to meet specific individual and company needs.

Please Contact us to discuss your in-house requirements.

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