In today's rapidly evolving healthcare landscape, the use of software in medical devices has become increasingly prevalent. Among these software categories, two (02) terms that are often used interchangeably but hold distinct meanings are SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device). In this blog, we will delve into the world of SiMD, its definition as provided by the Regulatory agencies, and the Regulatory guidelines governing its development and use.
Definition of SiMD by Regulatory Agencies
The Regulatory agencies around the world have recognized the importance of software in medical devices and have provided specific definitions to differentiate between SaMD and SiMD. According to the US Food and Drug Administration (FDA), SiMD refers to software that is incorporated into a medical device to control its performance or provide specific functions. The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the European Union (EU) have also adopted similar definitions, emphasizing the integration of software into medical devices.
Difference between SaMD and SiMD
To better understand SiMD, it is essential to differentiate it from SaMD. SaMD refers to a software that is intended to be used for one or more medical purposes, without being part of a physical medical device. It operates on general-purpose computing platforms like smartphones, tablets, or personal computers. On the other hand, SiMD is a software that is an integral component of a physical medical device, contributing to its functionality and performance. SiMD cannot be used independently and relies on the associated medical device to perform its intended purpose.
Examples of SaMD and SiMD
The following examples bellow will illustrate the difference between SaMD and SiMD: .
SaMD: An Electrocardiogram (ECG) mobile application that runs on a smartphone and analyzes the user's heart rhythm to detect arrhythmias would be considered as SaMD. It operates on a general-purpose platform and does not rely on a physical device.
SiMD: Automated insulin pump used by individuals with diabetes consists of both hardware and software components. The software within the insulin pump that calculates and delivers precise doses of insulin based on real-time glucose readings would be classified as SiMD. The software is an integral part of the medical device, ensuring its proper functioning and treatment efficacy.
Regulatory Guidelines for SiMD
Developing and marketing SiMD requires adherence to Regulatory guidelines established by agencies like the FDA, MHRA, TGA and the EU. These guidelines aim to ensure patient safety and the effectiveness of medical devices. Let's briefly explore the regulations governing SiMD according to these authorities:
- Food and Drug Administration (FDA), United States
The FDA categorizes SiMD under the broader scope of medical devices and follows the same Regulatory pathways as other medical devices. Developers of SiMD must comply with the FDA's Quality System Regulation (QSR) and obtain premarket clearance or approval, depending on the risk classification. They must provide evidence of safety, effectiveness, and performance, along with risk management documentation. - Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
The MHRA regulates SiMD in the UK under the Medical Device Regulation (MDR). Manufacturers must classify their SiMD based on associated risks and follow the conformity assessment procedures outlined in the MDR. They need to provide technical documentation, conduct clinical evaluations, and demonstrate compliance with essential requirements to obtain a CE marking for their SiMD. - Therapeutic Goods Administration (TGA), Australia
According to the TGA, software can be part of a device when it is integral to the functioning of that device. This software is sometimes referred to as SiMD (Software in a Medical Device) and is usually supplied with the hardware device. The TGA regulates this software as part of that device. - European Union (EU) Guidelines, European Union
The European Union's guidelines for Medical Device Software (MDSW) are based on the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Manufacturers must classify their SiMD based on the intended use and associated risks. They need to conduct conformity assessments, maintain a Quality Management System (QMS), and provide detailed technical documentation to obtain CE marking.
IEC 62304 applies to lifecycle process of the SiMD and is classified into three (03) categories such as Class A, B and C based on their safety.
SiMD plays a crucial role in the functionality and performance of medical devices, contributing to improved patient care and treatment outcomes. Developers must adhere to these guidelines, providing evidence of compliance and obtaining necessary approvals or clearances. By following these Regulatory pathways, SiMD manufacturers can confidently bring innovative medical devices to the market, benefiting patients worldwide.
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