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3 min read
Medical Device Software’s Role in EU Healthcare Transformation
Understanding Software as a Medical Device
Software as a Medical Device (SaMD) is simply software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. SaMD can run on general-purpose (non-medical purpose) computing platforms, such as mobile phones, tablets, and computers. It is considered a medical device and includes in vitro diagnostic devices as well. SaMD may be used alone or in combination with other medical devices. It may interface with other medical devices, including hardware medical devices and other SaMD software, as well as general-purpose software. Mobile apps are also considered SaMD.
It could also include AI-based diagnostic tools which can be used to diagnose abnormalities in the human body such as tumors, fractures, etc. Let's delve deeper into this...
Role of SaMD in Healthcare
SaMD healthcare plays a very crucial role in healthcare by enhancing diagnostic accuracy for the detection of abnormalities in the human body, personalizing the patient’s treatment, and helping streamline clinical workflows. It not only empowers the healthcare provider but also the tools for monitoring and managing patients in real-time. SaMD can help healthcare providers predict health risks, provide remote consultations, and analyze patient data to predict risks, even helping improve patient outcomes and efficiency.
SaMD in EU Regulations
EU regulations do not employ the term "software as a medical device." Instead, they refer to it as medical device software (MDSW). SaMD specifically applies to software that is standalone and explicitly excludes software that is "embedded" within a physical medical device. On the other hand, MDSW encompasses software that can either be independent or integrated into a hardware medical device, provided it serves a distinct medical purpose alongside its role in driving or influencing the hardware medical device.
MDSW is software intended to be used (alone or in combination) for any of the purposes described in the definition of “medical device” in Article 2(1) of Regulation (EU) No. 2017/745 (EU MDR) or Regulation (EU) No. 2017/746 (IVDR).
In brief, MDSW is software that has a medical device purpose on its own.
The following guidance documents are released by the EU Commission for MDSW regulatory reference:
- MDCG 2019-11 on the Qualification and Classification of Software:
- MDCG 2019-16 on Cybersecurity for Medical Devices:
- MDCG 2020-21 on Medical Device Software’s Clinical and Performance Evaluation:
- MDCG 2023-4 MDSW – Hardware Combinations:
MDCG 2019-11 provides the criteria for determining whether the software qualifies as a medical device and the classification based on its intended use and the risk profile. This process helps in understanding the regulatory obligations and ensuring that the software is appropriately regulated.
MDCG 2019-16 addresses the cybersecurity aspects of medical devices, including MDSW. It covers the requirements that ensure the confidentiality, integrity, and availability of data processed by medical software to protect against cybersecurity threats.
MDCG 2020-21 helps in navigating through the clinical and performance evaluation of medical device software. It focuses on the need for comprehensive evidence that demonstrates the software performs as intended and is safe for patient use.
MDCG 2023-4 discusses the regulatory considerations for MDSW that interacts with hardware. It covers the requirements to ensure that the combined system meets all relevant safety and performance standards for the medical device.
Challenges and Solutions in MDSW Development
MDSW development can present several challenges, such as regulatory compliance, risks related to cybersecurity, and the need for rigorous clinical validation. Developers of MDSW must navigate the regulatory complexities and ensure the software meets stringent performance standards and safety. Solutions include adopting a robust software development life cycle, conducting clinical evaluations, and integrating cybersecurity measures.
Safety and Security of MDSW
MDSW developers must navigate EU MDR regulations comprehensively, covering defining aspects, qualification criteria, classification, clinical evaluation, CE certification, conducting regular risk assessments, and QMS. To foster ongoing innovation and prioritize public health, manufacturers of MDSW should grasp proposed regulations and implement a robust system that supports all device and software functionalities aligned with EU MDR Regulatory guidelines. This ensures high-quality, compliant patient healthcare delivery. Manufacturers must focus on PMS to monitor performance and address any issues that arise. Cybersecurity includes encryption, secure coding practices, and maintaining trust in MDSW.
Future of MDSW
The future of MDSW is promising with advancements in AI, machine learning, and big data, which are intended to revolutionize healthcare. MDSW will continue to enhance personalized medicine, predictive diagnostics, and telehealth services. As the regulatory framework evolves, companies must stay informed.
At Freyr, we understand the qualification and classification of your medical device software (MDSW) and provide a comprehensive roadmap to achieve CE marking under the EU MDR or IVDR. Adherence to these processes is paramount, ensuring device safety and efficacy and instilling confidence in Regulatory authorities and consumers in the EU market. For more regulatory support, reach out to us now! Stay informed. Stay compliant.
