Software medical devices in combination with hardware: The new MDCG guidelines
The MDSW include the types of increasingly common apps that analyze and process data and information collected by sensors and cameras embedded in wearable devices, such as smartwatches.
The guidelines address manufacturers directly in an effort to provide regulatory guidance for various types of such hardware (such as medical devices, medical device accessories, and standard electronic products) and outline the duties and responsibilities of manufacturers of MDSW operating in combination with external hardware that may belong to third-party manufacturers other than the software companies.
For some time now, the MDCG has produced dedicated guidelines on classifying software as a medical device under the MDR/IVDR (MDCG 2019-11).
Two sample cases
The guidelines posit two sample cases to illustrate regulatory considerations:
- a skin patch with an embedded sensor for collecting and transmitting the user’s physiological parameters to an MDSW application installed on a smartphone, which analyzes and processes the data for medical purposes;
- a wearable device (smartwatch) with an embedded sensor for collecting and transmitting the user’s physiological parameters to an MDSW application installed on a smartphone or on the smartwatch itself.
In both cases, the medical purpose cannot be achieved independently by the hardware component (the patch or the smartwatch incorporating the sensor) or the MDSW alone, as the MDSW needs the hardware and its sensor for data collection and transmission. In other words, hardware and software components are intended to interact in order to operate as a medical device as defined in Article 2 of the MDR.
Separate MDSW and hardware manufacturers
The duties and responsibilities of the MDSW manufacturer may vary depending on whether or not the hardware support is a certified medical device, especially if the manufacturer of the MDSW is not the manufacturer of the hardware support.
Consider the case of a smartwatch equipped with sensors for the collection of vital parameters, manufactured by a particular company, that then transmits the data and information collected to multiple applications developed by various manufacturers that analyze and process the data and information. Another example would be a skin patch equipped with sensors that transmits data to an application from a different manufacturer.
If the hardware is placed on the market as MD or MD accessory
Hardware operating in combination with the MDSW could itself qualify as a medical device or medical device accessory, if it falls under one of the following:
- it is part of a system as defined in Art. 22 MDR;
- it is hardware intended for use in combination with another medical device (software) as defined in Art. 2(1) MDR;
- it is an integral part of a medical device (the software).
In these cases, the MDSW manufacturer must demonstrate compliance with the requirements of the MDR, starting with the general safety and performance requirements in Annex I.
The MDSW manufacturer therefore must:
- verify, validate, and demonstrate the safety, reproducibility, compatibility, and interoperability of the medical hardware-device (or accessory) with the medical software-device with which it operates in tandem;
- in the clinical evaluation phase of the MDSW, assess its compatibility with the hardware, taking into account that the manufacturer’s medical intended use can only be achieved in combination with third-party certified hardware;
- as part of risk management and post-market surveillance, set up a communication channel to ensure timely reporting of any hardware-related changes or incidents.
On the other hand, with regard to the proper functioning of the hardware, the manufacturer of the MDSW may rely on its compliance with the MDR (as a certified medical device or medical device accessory) and therefore may not be held liable for any malfunction of the MDR if it is used for its intended purpose.
If the hardware is not a MD or MD accessory, but a generic consumer product
If the hardware does not meet the MDR requirements, it may be a standard electronic product with different rules applied. In these cases, the MDSW manufacturer cannot simply verify its safety and compatibility with the software in accordance with the above, but instead is responsible for the safety and performance of all hardware components intended to be used in conjunction with the medical software-device. Even during the clinical phase, the MDSW manufacturer must demonstrate that all hardware “configurations” claimed to be compatible with the medical software-device (e.g., various wearable devices that transmit data to the software application) actually are compatible.
In addition, the MDSW technical documentation must identify and describe all compatible hardware components.
Finally, at the level of risk management and post-market surveillance, the MDSW manufacturer must draw up a management plan for both the software and hardware component and actively monitor all information from the market, including information on third-party hardware (e.g., malfunctions) that could have an impact on the safety, performance, and interoperability of the MDSW.
Liability of varying degrees
It is evident that when there are different manufacturers, different and greater responsibilities are incumbent upon the manufacturer of the medical device-software in the event that the third-party hardware used in combination with the software does not comply with the MDR requirements (not being a medical device or accessory itself). In these situations, the MDSW manufacturer will have to take particular care to identify compatible hardware and assume the relevant responsibilities.
 As specified by MDCG 2023-4, for the purposes of this document the definition of “hardware” does not include desktop PCs or cloud computing platforms (servers).
 Established pursuant to Art. 103 MDR.
 According to Article 2(2) MDR, an accessory to a medical device is defined as “a product which, although not itself a medical device, is intended by the manufacturer to be used with one or more specific medical devices, in particular to enable those devices to be used in accordance with their intended purpose, or to specifically and directly assist the medical functionality of the medical device or devices in relation to their intended purpose.” The provisions of the MDR apply to the accessories of a medical device.