Guidance on Qualification and Classification of Software under the MDR and IVDR Published

The Medical Device Coordination Group (MDCG) has published a long awaited guidance document in October on the qualification and classification of software under Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR). 

The document intends to provide clarity primarily for medical device software manufacturers under which criteria a software falls within the scope of the MDR or IVDR and how classification rules are to be understood and applied.

Experts criticized the guidance almost immediately after publication for being not clear enough in important aspects.

Sources: MDCG guidance documents

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