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.
Course Benefits
- 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
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
Learning objectives
- 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
Next Steps
- Introduction to: ISO 13485 training course - Discover ISO 13485, it's importance and the links to the medical device directives. You'll look at comparisons between it's requirements and ISO 9001 and the Food and Drug Administration's Quality System Regulations
- Lead Auditor: ISO 13485 training course - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
- Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.
Contact Us
