October 24th, 2023 – Written by Mitchell Gorthy
Overview
MDCG has updated guidance on medical device software (MDSW) intended to work in combination with hardware or hardware components. MDSW integrations within medical devices are increasingly relevant in recent years. With increased accessibility to smart-devices (e.g. smartphones, smartwatches, tablets, etc.) the availability of information for patients and clinicians is unprecedented. However, this raises the question regarding the qualification, and the appropriate regulatory pathway of these device(s).
Medical Device Software and Hardware Combinations
Many MDSW apps create diagnostic or therapeutic medical information by processing data or signals derived from hardware or hardware components. Furthermore, those hardware or hardware components act as input and may also act as controls for the MDSW. These hardware or hardware components play an essential role in contributing to the medical purpose of MDSWs. To illustrate, the following list shows how various MDSW and hardware, or hardware components can work in combination:
Examples:
- External hardware component (e.g. sensor embedded in a dermal patch) providing input data to a MDSW app
- A) Manufacturer of hardware component and MDSW app are the same entity
- Example: Manufacturer X creates a dermal patch that incorporates a sensor intended to collect and relay data correlated to the user’s physiological parameters (body temp, heart rate, etc.). Upon purchase, users download the MDSW app, also created by Manufacturer X on a smartphone and connect the two.
- B) Manufacturer of hardware component and MDSW app are different entities
- Example: Manufacturer X creates a dermal patch that incorporates a sensor intended to collect and relay data correlated to the user’s physiological parameters (body temp, heart rate, etc.). Manufacturer Y places on the market a MDSW app claimed to be compatible with the dermal patch of Manufacturer X.
- A) Manufacturer of hardware component and MDSW app are the same entity
- Hardware component incorporated within a smartphone or wearable connected to a MDSW app on a smartphone or wearable
- A) Hardware component incorporated within a wearable and MDSW app are the same entity
- Example: Manufacturer Z makes a wearable (e.g., watch) that incorporates a sensor intended to collect and relay data correlated to the user’s physiological parameters (body temp, heart rate, etc.). Upon purchase, users are prompted to download an app also placed on the market by Manufacturer Z on their smartphone and/or wearable.
- B) Manufacturer of wearable and MDSW app are different entities
- Example: Manufacturer Z places on the market a wearable (e.g., watch) that incorporates a sensor intended to collect and relay data correlated to the user’s physiological parameters (body temp, heart rate, etc.). Users can download a variety of MDSW apps places on the market by different MDSW app manufacturers. Manufacturer D claims that their MDSW app achieves its intended medical purpose the best.
- A) Hardware component incorporated within a wearable and MDSW app are the same entity
Regulatory Considerations:
As per the MDR, a medical device can achieve its intended purpose either alone or in combination with other medical devices or accessories. The examples provided are not able to achieve a medical purpose on their own. For MDSW qualification, the manufacturer must claim medical purpose and provide evidence that the device is MDR compliant. Various options exist for placing these types of devices on the market.
Options
- Option 1: Place the hardware or hardware component on the market as an accessory to a MDSW.
- Option 2: Place the hardware or hardware component on the market as a medical device either:
- A) as a part of a system according to article 22 MDR or
- B) as a combination with another medical device according to article 2(1), or
- C) as an integral part of a medical device
- Option 3: the hardware or hardware component isn’t a medical device
How can Enerxen help?
Enerxen is a trusted partner for Medical Device Software – Hardware combination devices, providing invaluable support to companies navigating the EU MDR. We understand the unique challenges and nuances of the regulatory landscape and are committed to helping you achieve compliance efficiently and effectively.
Contact us today to get started towards the path of regulatory success with a complimentary consultation with one of our seasoned experts. We will work closely with you to tailor a regulatory strategy. Additionally, find a more in-depth overview to our service what we do here.