In Vitro Diagnostics Regulation

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TRAINING

In Vitro Diagnostics Regulation

The new EU-IVDR brings about many changes, including many definitions, new conformity assessment routes, new Notified Body designations and more. On top of that, there is a completely revised rule-based classification system and stricter requirements for safety and on analytical and clinical performance. Much more details have been included in the general safety and performance requirements replacing the current essential principles of the Directive, and above all: no grandfathering.

 

 

 

 

IN VITRO DIAGNOSTICS

All In Vitro Diagnostics trainings

Fundamentals IVDR

The new structure and revised scope of the IVD, the classification rules, technical documentation changes and Post Market surveillance, you will learn during this course.

 

IVDR Transition 

This training focusses on practical guidance to implement IVDR from determining the gaps from your current documentation and processes and the IVDR requirements.

 

How to write a technical file

This training focusses on practical guidance to fulfil the technical documentation requirements in the EU-IVDR.

 

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