European Commission’s MDCG publishes new guidance

The European Commission’s Medical Device Coordination Group (MDCG) has published guidance that explores scenarios for hardware or hardware component manufacturers whose products may use medical device software (MDSW) that requires conforming to EU regulations.

MDCG published the “Guidance on MDSW intended to work in combination with hardware or hardware components” (MDCG 2023-4) in October 2023. It is intended to clarify when hardware or hardware components that use MDSW would be considered medical devices or accessories to medical devices, and what regulations would apply to them. Issues such as clinical evaluation and cybersecurity are not part of the guidance but are addressed in other guidances.

MDSW applications are often used to process data from hardware or hardware components to output diagnostic or therapeutic medical information, MDCG noted. The group provided examples of how such apps and hardware can work together and how they may conform with applicable regulations.

“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,” the guidance said.

More specifically, the guidance breaks down the types of apps and hardware into two categories. The first category includes external hardware components that provide input data to the MDSW apps, such as sensors embedded in dermal patches. The second category includes hardware components that are incorporated into products, such as smartphones and fitness trackers that use MDSW apps.

Based on the EU Medical Device Regulation (MDR), the intended purpose of the medical device will determine whether it is a stand-alone device, a combination with a medical device, or an accessory to a medical device, according to MDCG.

There are certain scenarios where the MDSW and the hardware or hardware component are not able to achieve the intended medical purpose alone, and to be considered a medical device, the manufacturers have to claim a medical purpose and provide evidence that they are in compliance with MDR. The guidance goes on to detail three scenarios where a device or MDSW app, in combination with other products, can prove its medical purpose in order to be placed on the market.

In the first scenario, the MDSW can use the hardware or hardware component as an accessory, which would qualify it for market. In the second scenario, the hardware or hardware component can be considered a medical device if it is part of a medical system, if it works in combination with another medical device, or if it is considered an integral part of the medical device. Finally, the last scenario is where the hardware or hardware component is considered an integral part of the general consumer product or digital wearable but is not a medical device or an accessory.

In situations in which a hardware or a hardware component is qualified as a medical device or an accessory to a medical device, the MDSW manufacturers must show that the product is in compliance with MDR on general safety and performance requirements (GSPRs).

“Of specific importance, the MDSW manufacturer must verify, validate and demonstrate the safety, reproducibility, compatibility and interoperability of the medical device or accessory to a medical device that the MDSW works in combination with, including all various configurations and variants,” the MDCG wrote in the guidance. “The clinical evaluation of the MDSW has to be considered in view of the intended medical purpose achieved in combination with medical device or accessory to a medical device.”

The software manufacturer, however, may rely on the hardware manufacturer’s compliance with MDR when the app is used for its intended purpose. When considering risk management and post-market surveillance, the guidance states that the app developer must ensure there are sufficient communication mechanisms in place to notify the necessary parties of safety signals.

It is, however, not enough to verify the safety, performance, reproducibility, interoperability, and compatibility of the MDSW in situations where the app manufacturer is unable to rely on the hardware to comply with MDR. In those cases, the app manufacturer must take responsibility for the safety, performance, and reproducibility of the hardware that is used in combination with the software, according to the guidance.

“The MDSW’s technical documentation must clearly identify and describe all other products (e.g., hardware or hardware component which are not qualified as a medical device or accessory to a medical device) that are intended to be used in combination with it,” MDCG wrote. “As part of the risk management, the MDSW manufacturer must establish and document a risk management plan for both the MDSW and the hardware or hardware component that may have an impact on the MDSW’s safety and performance.” RAPS.org