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European Commission provides important guidance on qualification/classification of software under new Medical Devices Regulations

European Commission provides important guidance on qualification/classification of software under new Medical Devices Regulations
Published on: 31 October 2019
Published by: LexisPSL
  • European Commission provides important guidance on qualification/classification of software under new Medical Devices Regulations
  • Key points to highlight
  • Conclusion

Article summary

Life Sciences analysis: The European Commission’s Medical Devices Coordination Group (MDCG) has published a much-anticipated guidance on the qualification and classification of software devices as medical devices (MDSW)1 under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the Guidance, available here). The Guidance seeks to provide clarification to medical software manufacturers with respect to (i) when software is considered a device (qualification) and (ii) what risk category the device falls into (classification). or take a trial to read the full analysis.

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