On Mar 18, 2025, the European Commission (EC) published the revised guidance on classification rules for In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746, under MDCG 2020-16 rev.4.
The purpose of this document is to provide guidance to manufacturers, Notified Bodies (NB), and healthcare institutions on how to classify In Vitro Diagnostic Medical Devices before placing them on the market, making them available on the market, or putting them into service.
Under IVDR (EU) 2017/746, devices are classified into classes A, B, C, and D based on their intended purpose and risk. The specific requirements outlined in the IVDR are directly linked to the device classification, making it crucial to classify the device correctly according to Annex VIII.
In particular, the conformity assessment pathways and post-market requirements vary depending on the classification. For higher-risk classes, such as C and D, the evaluation pathways become more complex, and post-market requirements increase.
Please refer to the attached document below.
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