It’s no secret that software has become an integral part of many medical devices on the EU market. It is estimated that a quarter of medical devices either incorporate a software or could be considered to be a medical device software in their own right. In many cases, the MDSW can only achieve its intended purpose when the device is used in combination with a hardware product, such as a sensor which would be used for generating the input data.
Since the hardware components of these devices play a vital role in contributing to the medical intended purpose, it is of importance to consider how these manufacturers demonstrate conformity with the applicable regulatory requirements.
The Medical Device Coordination Group (MDCG) has recently published a guidance on MDSW that is intended to work in combination with hardware components. The guidance intends to examine as well as provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) is a medical device or an accessory to a medical device. Conversely, the document also helps in outlining scenarios in which the hardware of hardware component incorporating a data collection element are not considered a medical device.
The guidance breaks down the types of apps and hardware into two main categories.
- The first category encompasses external hardware components that provide input data to the MDSW apps, such as sensors.
- The second category encompasses hardware components that are incorporated into products, such as smartphones that use MDSW apps.
The guidance also differentiates between scenarios where the manufacturer of the hardware and software are the same entity and different entities.
The guidance can be accessed using the following link
