Gain an understanding of the requirements placed on the development and supply of in vitro diagnostic medical devices on this In Vitro Diagnostic Regulations (IVDR) training course.

IVDR is replacing the In Vitro Diagnostics Directive (IVDD) for greater patient protection and smoother market function.

This 1-day course explores the requirements of EU regulations for those involved in the medical devices supply chain.

Upon completion of the course delegates will be able to apply EU 2017/746 within their organisation and help to identify areas for improvement on a continual basis.

This course is appropriate for anyone who is jointly or fully responsible for regulatory compliance, and is working in an organisation involved in any aspects of in vitro diagnostic medical device manufacturing, designing, marketing or the supply chain, and wants to understand and be able to apply the requirements of the new regulation EU 2017/746.

The course includes key topics such as:

  • scope and definitions
  • regulation governance actors
  • classification
  • conformity assessment procedures
  • quality management system requirements
  • technical documentation
  • general safety and performance
  • risk management
  • clinical evidence requirements
  • post-market surveillance and vigilance
  • identification and traceability
  • supply chain requirements
  • notified bodies

On completion of this IVDR training course delegates will be able to:

  • apply the requirements of EU 2017/746
  • explain the European regulation CE marking approach for medical devices including its legal and operational basis
  • describe the structure and scope of the IVDR including classification and conformity routes
  • review the safety and performance requirements checklist applicable to CE marking under the new regulation
  • understand the new requirements when creating technical documentation to support the product throughout its life cycle
  • understand the level of clinical evidence necessary to demonstrate conformity
  • learn how to develop a robust and proactive post market surveillance system under the new IVDR including vigilance reporting and monitoring
  • identify the regulatory significance of a robust quality management and risk management system
  • gather information about the business impacts of the regulation and start to develop a transition plan