Application of the In Vitro Diagnostic Directive Training Course

Level Specialist Duration 3 days

Available to book: Virtual classroom View dates and book now

This three day course has been designed to enable participants to explore the IVD Directive, gain a greater understanding of the requirements and thus enable IVD devices to be placed on the European market.

How will I benefit?

Participants will be able to apply the requirements of the directive to create technical documentation to support the product throughout its lifecycle. Managers and quality/regulatory professionals responsible for all aspects of IVD CE marking as well as internal and external auditors, will benefit from attending this course.

On completion of this training, participants will be able to:
- Explain the European CE marking approach for IVD’s including its legal and operational basis
- Describe the structure and scope of the IVDD including classification and conformity routes
- Apply the essential requirements including labelling and develop suitable technical documentation
- Identify the regulatory significance of risk management and process validation
- Combine knowledge gained from the course with audit qualifications to conduct compliance audits of their organization and suppliers
- Explain the role and importance of performance evaluation including application of the Common Technical Specification (CTS)
- Interpret the criteria for reporting adverse incidents under the vigilance system
- Define the manufacturers regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body
- Regulatory & quality personnel
- People new to companies or roles impacted by the IVD Directive
- Distributors of IVD’s
- Virtual manufacturers
- Start-up companies
- R&D personnel
- Internal auditors
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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