In Vitro Diagnostics Regulation

Training

In Vitro Diagnostics Regulation (IVDR)

The new EU-IVDR entered into force in May 2017 and will have a transition time up to 26 May 2022 to meet the requirements of the IVDR. Although there are new transitional arrangements made in December 2021, there's still a lot of work to do. 

The new regulation will replace 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. In our technical documentation training and clinical evidence we train your staff how to manage.