Software now plays a growing and vital role in the medical device landscape. In many cases, Medical Device Software (MDSW) can only achieve its intended purpose when it is used in combination with hardware or hardware components. Therefore, it is important to consider how the manufacturer of the MDSW has to demonstrate conformity with the applicable regulatory requirements for the combination of the MDSW.
The purpose of MDCG 2023-4 is to clarify which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element is classified as a medical device or an accessory to a medical device. It also outlines scenarios where such hardware or hardware components, with data collection elements, do not meet the criteria for classification as medical devices or accessories to medical devices.
In this guidance, different examples of how MDSW and hardware or hardware components work in combination to achieve a medical purpose and how they may be placed on the market are described.
Some MDSWs and their hardware components are unable to independently serve a medical purpose. To classify the software as a medical device, the manufacturer must claim a medical purpose and consequently provide evidence that the device in question is in compliance with the MDR. This includes the need to verify, validate, and prove that the interaction between the MDSW and the hardware or hardware component leads to an effective, safe, and performant MDSW.
This guidance offers multiple options for how devices, MDSW, and other products requiring interaction to achieve the intended medical purpose can be placed on the market. For detailed information on these options, please refer to the provided reference.