EU Medical Device and In Vitro Diagnostic Regulation (EU MDR & IVDR)

The European regulatory landscape is changing quickly, becoming stricter and more technically challenging for medical device companies.

With major changes in legislation affecting device classification and requirements for technical documentation and clinical evidence, companies will need EU Medical Device Regulation (EU MDR) and EU In Vitro Diagnostics Regulation (EU IVDR) training. Our courses provide comprehensive instruction on the EU MDR and EU IVDR. We walk you through every aspect of the regulation and identifies key topics and changes, including the new roles associated with the EU MDR and EU IVDR, standard requirements that must be met by all manufacturers regardless of class and the requirements for conformity assessments.

Our courses teach you how to successfully implement these changes to plan for an efficient transition in your organization.