IVDR Training courses to meet the IVDR requirements

In Vitro Diagnostics Training

IVDR Training courses

The new EU-IVDR entered into force on the 26th of May, 2022. To meet the requirements of the IVDR and the transitional arrangements, Qserve offers IVDR Training courses to educate your team. Although there is an extension to the transitional arrangements, there's still a lot of work to do. 

The new regulation replaced the EU's current Directive on in vitro diagnostic medical devices (98/79/EC) and has a great impact on IVD manufacturers and the manufacturer of currently approved in-vitro diagnostics.

In our different online and customized training sessions, we will explain all the changes, the new definitions, and new conformity assessment routes and guide you through the completely new risk-based classification system for Class A to D.

We guide you on how to work with Notified Body designations, while the majority of IVDs currently self-certified will now require the services of a Notified Body in the conformity assessment process to ensure the intended purpose of the devices and their inherent risks. All currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements so no grandfathering.

And on top of that the level of detail regarding the contents of the technical documentation is increasing substantially. Our IVDR Training courses provide technical documentation training and clinical evidence to train your staff on how to manage.