Last October 2023, the Medical Device Coordination Group (MDCG) approved the MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW guideline intended to work in combination with hardware or hardware components, which deals with Medical Device Software (MDSW) intended to work in combination with hardware or hardware components.
The guideline aims at clarifying the interaction between MDSW and hardware, specifically, it describes whether the hardware or hardware component, which works in combination with MDSW, is a medical device or an accessory of a medical device.
This document describes several examples of how a MDSW and a hardware or hardware component work in combination to achieve a medical purpose and how they can be placed on the market.
The intended medical purpose of a MDSW can only be achieved through the use of hardware or hardware components that demonstrate sufficient safety, performance, precision and reliability in light of the intended purpose of a MDSW and the state of the art.
The guideline also contains three possible scenarios:
- Scenario 1: The hardware or hardware component is placed on the market as an accessory of the MDSW.
- Scenario 2: The hardware or hardware component is placed on the market as a stand-alone medical device.
- Scenario 3: The hardware or hardware component is an integral part of the general consumer product. It is not a medical device or an accessory to a device and has no medical purpose.
Examples of these possible scenarios are also given:
- Sensor embedded in a dermal patch providing input data to a MDSW application falling under scenario 2.
- Sensor embedded in a smartphone or wearable connected to a MDSW application on a smartphone or wearable that falls under scenario 1.
In terms of market placement, MDSW manufacturers must demonstrate compliance with MDR (EU) 2017/745, including general safety and performance requirements. The manufacturer, specifically, must verify, validate and demonstrate the safety, reproducibility and compatibility of the hardware with which the MDSW works in combination, including all the various configurations and variants.
In terms of risk management and post-market surveillance, the MDSW manufacturer must systematically monitor and evaluate all information from the market throughout the MDSW life, as well as hardware or hardware components that may affect the safety and performance of the MDSW.
The increase in the use of software in Medical Devices is prompting regulators to commit to providing guidance that can help manufacturers make devices that increasingly meet safety and performance requirements to safeguard the lives of end-users.
>> Through the services of strategic-regulatory consulting, support to EC certification and, if necessary, European Authorised Representative Thema can help you implement the requirements of Regulation 2023/607 to take advantage of the extension and the MDR (EU) 2017/745.
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