IVDR Training courses to meet the IVDR requirements

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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. 

Are you interested in our IVDR Training courses?

Our expert staff delivers courses for professionals at all career stages, ensuring tailored, high-quality training. We are happy to discuss your wishes and needs.

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In-vitro diagnostics

All IVDR Training courses help you take steps further to compliance

IVDR Transition 

1 day customized training | Practical guidance to implement IVDR from determining the gaps from your current documentation and processes and the IVDR requirements.


From IVD to IVDR

6 customized training sessions on IVDR implementation | The sessions can be tailormade to your product portfolio and can be focused on your situation as a start-up or a company transitioning to the IVDR.


IVDR Fundamentals

The new structure and revised scope of the IVD, the classification rules, technical documentation changes, and post-market surveillance. 

Preparing QMS for IVDR

What will change? What to expect in unannounced audits? Internal audits and IVDR readiness.

Technical Documentation

How to get started, preparing and compiling technical files, what are the requirements and keeping the file up to date.

How to work with a NB?

How to select and work with Notified Body's (NB's / NoBo's) effectively.

Risk Management

Understand the key concepts of risk management and how to use ISO 14971 to meet the IVDR.


Learn about the PMS and PMPF requirements and how to prepare plans and reports and implement them for existing devices.

Clinical Evidence for the IVDR

Understand the IVDR requirements, including the intended purpose, scientific validity, literature searches, and analytical and clinical performance.


Manufacturers and authorized representatives are required to appoint a Person Responsible for Regulatory Compliance (PRRC) within both the IVDR and MDR.