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MDCG publishes guidance on classifying software under the MDR and IVDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Commission’s Medical Device Coordination Group (MDCG) has released guidance to help medical software manufacturers understand the criteria for the classification of software under the Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746).

The document is titled ‘Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR’, and copies are available from here.

The 28-page guidance includes decision trees, and explains that the criteria specified also apply to applications (commonly referred to as apps), which may be operating on a mobile phone, in the cloud, or on other platforms.