Introduction to CE Marking for the In Vitro Diagnostics Directive

Understanding the In Vitro Diagnostics Directive (IVDD) is vital to marketing medical devices in the EU. Our Introduction to CE Marking for the In Vitro Diagnostics Directive outlines all you need to know about making your products IVDD compliant to gain European market access.

IVDD is one of three directives that monitor product quality and safety within the CE framework. And you will need IVDD compliance if your device is designed to diagnose medical conditions without patient contact.

“We chose BSI for its international reputation for excellence. It is a trusted organisation with unrivalled experience.”

Our one day course will explain the entire process. Working with our qualified practitioners you will understand what’s required by the IVDD and CE Marking. And you can go on to develop IVD quality products, meet safety standards, gain EU market access, satisfy customers and maintain compliance throughout the product lifecycle.

Learning objectives

• Understand the relationship between CE Marking and IVDD
• Be able to identify and classify IVD medical devices 
• Understand the structure and scope of the IVDD
• Be confident using technical documentation to support compliance
• Take the lead in post-market surveillance and reporting
• Gain professional recognition as a regulatory expert.

Benefits of attending this course?

• 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.