In vitro diagnostic regulation training courses (IVDR)

The In Vitro Diagnostic Regulation (IVDR), is a comprehensive set of European Union (EU) rules that govern the production, sale, and distribution of in vitro diagnostic devices. These devices play a crucial role in analyzing human samples, like blood or tissue, outside the body, providing essential data for medical diagnoses and treatment planning.

The In Vitro Diagnostic Regulation details the requirements which manufacturers have to meet to sell In Vitro Diagnostic devices in the European Union. It replaces the In Vitro Diagnostic Directive. 

This course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.

This course will guide you through IVDR implementation. Find out best practices to implement a compliant QMS and prepare a thorough Technical Documentation package to obtain CE mark for your in vitro diagnostic medical device.