• Feature ArticlesFeature Articles

    Medical device software under the EU MDR

    The EU Medical Device Regulation (MDR) has been published with new medical device software (MDSW) requirements. Qualification guidance to determine if software is MDSW was combined with guidance for MDSW classification. However, the EU Medical Device Directive (MDD) guidance for clinical evaluation, which should have been replaced, is still in use. The change to the MDR has introduced new problems for clinical evaluation, so guidance has been introduced for equivalence, le...
  • Feature ArticlesFeature Articles

    What is Sufficient Clinical Evidence According to the MDR?

    This article evaluates what is considered “sufficient clinical evidence” and covers its important place in Medical Devices Regulation (MDR). The author defines sufficient clinical evidence and discusses the kinds of clinical evidence required by MDR and what evidence can be considered state-of-the-art. Equivalent devices and benchmark/similar devices are discussed as well as performance studies.   Introduction   Presenting sufficient clinical evidence is an importa...