Introduction to CE Marking for the In Vitro Diagnostics Directive
This one day course has been designed to introduce the In Vitro Diagnostics Directive (IVDD), the types of product covered by the Directive and the regulatory framework required for placing IVD products on the European market.
On completion of training, participants will be able to apply knowledge of the directive to the development of IVD products as well as their on-going maintenance to achieve continued regulatory compliance throughout the lifecycle of the product.
Who should attend?
- Senior management
- Regulatory, quality, research, design, development, manufacturing, marketing managers and personnel
- Organizations preparing ‘own brand’ or ‘private label’ devices
- Distributors of IVDs.
“We chose BSI for its international reputation for excellence. It is a trusted organisation with unrivalled experience.”
What will I learn?
On completion of this training, participants will be able to:
- Explain the European CE marking approach with respect to IVDs
- Describe the structure and scope of the IVDD
- Identify what is an IVD device
- Classify IVD devices and determine appropriate conformity routes
- Describe the role of essential requirements as the basis for CE marking including the use of standards and an awareness of the technical documentation to support compliance
- Describe the requirements for performance evaluation
- Identify the necessary steps required for post-market surveillance and the reporting of adverse incidents under the vigilance system.
How will I benefit?
- Gain recognition as a producer of products with CE Marking
- Ensure the quality and safety of your medical devices
- Increase EU market access with IVD medical devices
- Boost customer confidence and satisfaction
- Encourage professional development across employees.
- You will gain 8 CPD points on completing the course
- Training course notes