Gain an understanding of how the European Directive on medical devices affects manufacturers on this Understanding the European Directive 93/42/EEC concerning Medical Devices.

The 1-day course explores the Articles and Annexes of the European Directive 93/42/EEC and the relevance of ISO 13485, the quality standard for the medical device industry. It examines the roles of regulatory bodies and the requirements placed on manufacturers of CE-marked medical devices.

The training uses interactive workshops and discussion groups to encourage teams to work together as they consider how to apply this knowledge within their organisation.

The course is suitable for anyone involved in designing and developing medical devices for the EU market, including:

  • general managers/business unit managers
  • quality and regulatory professionals
  • management representatives/
  • internal and external auditors
  • those seeking an understanding of the Directive

This course complements our range of training courses for designing, developing and marketing medical devices.

Key topics covered on this course include:

  • 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
  • roles of the bodies defined in the Directive, particularly the MHRA
  • allowed paths to be able to use a Declaration of conformity and the CE mark
  • 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

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 which affect decision-making on the acceptability of risks in bringing a device to market

A Certificate of Completion will be awarded to delegates who attend the whole course.

Understanding the European Directive Certificate

We offer this course as dedicated training for your organisation. This enables you to choose the venue and timing to suit your team. Choose your own premises, an offsite venue, or seats in our Virtual Classroom.

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