European Union In Vitro Diagnostic Device Regulation (IVDR)

This two-hour course provides comprehensive instruction on the EU In Vitro Diagnostic Device Regulation. It covers all aspects of the regulation and identifies key topics and changes, including the economic operators and new roles associated with EU IVDR, standard requirements that must be met by all IVD manufacturers, and pre- and post-market requirements of conformity assessment.

By the end of this course, you will be able to:

• Recognize the major changes for the EU in the new IVD Regulation
• Identify key roles associated with the EU IVDR
• Discuss the requirements of the IVD Regulation for key actors
• Explain how to comply with pre- and post-market requirements for conformity assessment

NSF’s EU IVDR course is helpful for all medical device professionals, management and executive personnel looking to expand their knowledge of the EU IVDR.

By completing/passing this course, you will attain the Medical Device Certificate.