Understanding the latest IVDR Classification Rules


The implementation of the EU MDR came into force in May 2021, and the classification of medical devices has changed. Our comprehensive guide covers everything you need to know about the classification rules for in-vitro diagnostic devices – and will ensure your products always meet the latest requirements.

Download your copy of the essential IVDR Classification Rules Guide below…

Understanding the changes is essential for all users, as methodology classification is substantially different across standard medical devices and in-vitro diagnostic devices. This is because IVD devices cannot directly harm the patient in the same way a standard medical device potentially could. By downloading the IVDR Classification Rules Guide, you’ll gain knowledge about:

  • The four risk classes that have been created to determine the highest and lowest risk IVD devices
  • The seven classification rules that give devices their risk class
  • Conformity assessments and how they’re dependant on the risk class of the IVD device

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