The regulation of medical device software (MDSW) is a challenging area, in view of the numerous configurations in which it can be used and how it interacts with hardware. Thus, the new guidance document, MDCG 2023-4, on MDSW meant to work in conjunction with hardware components which has been issued by the European commission’s Medical Device Coordination Group (MDCG).
It is the interaction between the MDSW, hardware or hardware components, especially integrated sensors, which brings into question the qualification and the correct regulatory pathway or conformity assessment of these hardware or hardware components. The document looks at, and explains which particular regulatory factors apply when the hardware or hardware component incorporating the data collection element, for example camera, is a medical device or an accessory to a medical device.
The guidance also explains circumstances where the hardware or hardware component incorporating a data collection element are not medical devices or accessories to a medical device.
The guidance includes a section explaining different examples of how MDSW and hardware, or hardware component, function in combination to achieve a medical purpose and how they can be placed on the market. Homing in on the case of external hardware components delivering input data to a MDSW app, the guidance examines the regulatory position of a sensor inserted in a dermal patch, both where the manufacturer of the hardware component and the MDSW app are the same individual and where they are different people. After that, it goes into cases where the manufacturer of the hardware component is incorporated within a smartphone or wearable connected to a MDSW app or smartphone or wearable.
In respect of regulatory conclusions, the guidance states that it is apparent that the MDSW, and the hardware or hardware component, are incapable of achieving a medical purpose on their own. For the software to be eligible as a medical device, the manufacturer has to ascertain a medical purpose and accordingly present verification that the said device abides by Regulation (EU) 2017/745 on medical devices (MDR). This means having to verify, substantiate and ascertain that the interaction between the MDSW and the hardware, or hardware component, produces a valuable, safe and well-performing MDSW.
The guidance offers helpful background information to grasp the context of its guidance, including an estimation that about 25% of medical devices either incorporate MDSW or are, in themselves, MDSW.
Source: Medtech Insight (an Informa product)