Clinical evaluation strategy for Medical Device Software certification under MDR/IVDR

The use of medical device software has become a prevalent trend, yet not all software within the healthcare domain meets the qualifications to be considered a medical device.

Within the framework of MDR/IVDR software must have a medical purpose on its own to be qualified as a medical device software (MDSW) regardless of whether the software is independent or driving or influencing the use of a device. In the context of software, clinical benefit may be considered slightly differently from that for pharmaceuticals or other medical devices as most commonly lies in obtaining or collating clinical information which assists with clinical decision making. Nevertheless, MDSW is subject to the same general clinical evaluation (MDR) / performance evaluation (IVDR) principles, laid down in the applicable guidelines and regulatory documents, as other MDs/ IVDs. Additionally, key recommendations for MDSW can be found in theMDCG 2020-1andIMDRF/SaMD WG/N41.

The quality and breadth of the clinical evaluation is determined by the role of the MDSW for the target clinical condition, and assures that the output of the MDSW is clinically valid and can be used reliably and predictably. To achieve this some specific steps should be included into the manufacturer's approach to generating evidence for the clinical evaluation of a MDSW:

1. to verify that the association between the MDSW output, based on the inputs and algorithms selected, and the targeted clinical condition is supported by evidence (valid clinical association);
2. to generate evidence that the output of the MDSW is technically what is expected (analytical validation);
3. to generate evidence that the MDSW generate clinically relevant outputs, in particular that the MDSW has been tested in the target population and for the intended use, and that Users can achieve clinically meaningful outcomes through predictable and reliable use (clinical validation).  

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