Introduction to CE Marking for the In Vitro Diagnostics Directive
Our one-day Introduction to CE Marking for the In Vitro Diagnostics Directive training 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.
There are no pre-requisites for this course, but a strong knowledge of ISO 13485 is highly recommended.
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
- 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
- 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
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