In Vitro Diagnostics Regulation

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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, 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. 

IN VITRO DIAGNOSTICS

All trainings on IVDR 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.

PMS and PMPF

Learn the PMS and PMPF requirements, how to prepare plans and repost and implementation for existing devices.

Clinical Evidence for the IVDR

Understand the requirements for the IVDR, including the intended purpose, Scientific Validity and literature searches, Analytical and Clinical Performance.

PRRC

Manufacturers and Authorized representatives need to appoint a Person Responsible for Regulatory Compliance (PRRC) within the IVDR and MDR. 

How can we help you? Contact us