MDCG Guidance on Medical Device Software (MDSW) – Hardware combinations

The Medical Device Coordination Group (MDCG) endorsed in October 2023 a new guidance on medical devices software (MDSW) intended to work together with hardware or hardware components. Some examples of MDSW with hardware are devices with sensors, such as wearables, which generate data to prevent, predict, or manage a disease.

The new guidance, MDCG 2023-4, helps clarify whether the hardware or hardware component incorporating the data collection element is a medical device or an accessory to a medical device. Based on how a medical device software and hardware or hardware components work together in order to achieve the intended medical purpose, the manufacturer has to follow different approaches to place the product on the market.

Hardware or hardware component not able to achieve a medical purpose on their own

In the case of an external hardware component providing input data to an MDSW app, the hardware component might not be able to achieve a medical purpose on its own. Similarly, when a product comprises a hardware component incorporated within a smartphone or wearable connected to an MDSW app, the intended medical purpose might not be achieved by the hardware alone.

In such cases, there are different options for the manufacturer:

1. The hardware or hardware component is placed on the market as an accessory to an MDSW
2. The hardware or hardware component is placed on the market as a medical device, either
   • as part of a system according to article 22 MDR, or
   • as a combination with another medical device according to article 2(1), or
   • as an integral part of a medical device.
3. The hardware or hardware component is an integral part of the product (such as a general consumer or digital product), and is not a medical device or an accessory to a medical device, and has no intended medical purpose.

Examples of such products include MDSW apps that create diagnostic or therapeutic medical information by processing data or signals derived from hardware or hardware components (e.g., a dermal patch that incorporates a sensor). Also, watches with a sensor that collects and relays data correlated to the user’s physiological parameter belong to such category.

How to place such MDSW with hardware on the market

When the MDSW and the hardware or hardware component are either a medical device or an accessory to a medical device (options 1 and 2 presented above), the manufacturer has to:

• Demonstrate compliance with the MDR for both the MDSW and hardware/hardware component, including general safety and performance requirements (GPSR) requirements
• Verify, validate, and demonstrate the safety, reproducibility, compatibility, and interoperability of the medical device or accessory
• Have a clinical evaluation drafted given the intended medical purpose
• Establish and implement communication channels to ensure efficient notification mechanisms for changes or incidents

When the MDSW and the hardware or hardware component is not a medical device and has no intended medical purpose, the manufacturer has to:

• Be responsible for the safety, performance, and reproducibility of the hardware or hardware component in its combined use with the MDSW
• Comply with the applicable requirements as per Article 22(4) of the MDR (when the manufacturer is combining a medical device with another product)
• Identify and describe all other products (in this case, the hardware or hardware component) in the MDSW technical documentation
• Establish and document a risk management plan for both the MDSW and the hardware or hardware component
• Demonstrate clinical evidence for all intended configurations
• Monitor and assess post-market surveillance information derived from the MDSW as well as from the hardware or hardware component
• Put in place and implement controls of the hardware or hardware component

Are you a medical device software manufacturer and want to know more about MDSW requirements in the EU and UK? Contact us with your queries!