EU MDCG Guidance on Medical Device Software and Hardware Component Integration

The European Commission's Medical Device Coordination Group (MDCG) has released guidance aimed at assisting manufacturers of hardware and hardware components that incorporate medical device software (MDSW) in complying with European Union (EU) regulations.

This guidance, designated as "Guidance on MDSW intended to operate in conjunction with hardware or hardware components" (MDCG 2023-4), was issued in October 2023. Its primary purpose is to provide clarity on the classification of hardware and hardware components utilizing MDSW as medical devices or medical device accessories, as well as the relevant regulatory requirements. It's important to note that topics like clinical evaluation and cybersecurity are not covered in this guidance but are addressed in separate documents.

MDSW applications are frequently utilized to process data from hardware or hardware components, producing diagnostic or therapeutic medical information. The MDCG has offered examples of how these applications and hardware can work together and align with applicable regulations.

According to the guidance, "The intended medical purpose of such MDSW apps can only be achieved through the use of hardware or hardware components that demonstrate sufficient performance, accuracy, and reliability, in light of the MDSW’s intended purpose and the state of the art."

More specifically, the guidance divides these apps and hardware into two categories. The first category encompasses external hardware components that supply input data to MDSW applications, such as sensors integrated into dermal patches. The second category includes hardware components integrated into products, such as smartphones and fitness trackers that employ MDSW applications.

In accordance with the EU Medical Device Regulation (MDR), the medical device's intended purpose will determine whether it is considered a standalone device, part of a combination with a medical device, or an accessory to a medical device.

There are specific situations where the MDSW and hardware or hardware components cannot independently achieve the intended medical purpose. To be classified as a medical device, manufacturers must assert a medical purpose and provide evidence of compliance with the MDR. The guidance outlines three scenarios where a device or MDSW application, combined with other products, can demonstrate its medical purpose for market placement.

In the first scenario, MDSW can utilize the hardware or hardware component as an accessory, qualifying it for market entry. In the second scenario, the hardware or hardware component can be regarded as a medical device when it is part of a medical system, works in conjunction with another medical device, or is an integral component of a medical device. The final scenario involves the hardware or hardware component being considered an integral part of a general consumer product or digital wearable but not a medical device or accessory.

If hardware or a hardware component is deemed a medical device or accessory to a medical device, MDSW manufacturers must demonstrate compliance with MDR's general safety and performance requirements (GSPRs).

Importantly, the MDSW manufacturer must confirm, validate, and exhibit the safety, reproducibility, compatibility, and interoperability of the medical device or accessory with which the MDSW collaborates, encompassing various configurations and variants. The clinical evaluation of the MDSW should align with its intended medical purpose when used in combination with a medical device or accessory to a medical device.

However, in cases where the app manufacturer cannot rely on the hardware's compliance with MDR, they must assume responsibility for the safety, performance, and reproducibility of the hardware used with the software.

The MDSW's technical documentation must comprehensively identify and describe all other products (e.g., hardware or hardware components not classified as medical devices or medical device accessories) intended for use in conjunction with it. As part of risk management, the MDSW manufacturer must establish and document a risk management plan for both the MDSW and the hardware or hardware component that could impact the MDSW's safety and performance.