As software and technology continues to advance at a rapid pace, the healthcare industry has witnessed a significant transformation in the way medical devices are regulated and approved. In recent years, both the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and the International Medical Device Regulators Forum (IMDRF) have introduced guidelines specifically addressing standalone software used as medical devices. In this article, we will explore the similarities and differences between the UK MHRA standalone software and the IMDRF software as medical devices (SaMD) guidance documents, shedding light on their regulatory frameworks and implications.
The UK MHRA and IMDRF have both recognized the importance of regulating standalone software as medical devices to ensure patient safety and maintain the highest standards of quality in healthcare. While their regulatory frameworks have some similarities, there are also notable differences.
UK MHRA Standalone Software:
The UK MHRA defines standalone software as a software application that operates on a device, either alone or in combination with other hardware, to provide a specific medical purpose. The MHRA classifies standalone software as a medical device based on its intended use and impact on patient safety. The MHRA's regulatory framework places standalone software into different risk classes, ranging from low to high risk, depending on factors such as the level of invasiveness and the potential harm to patients.
The MHRA has provided clear guidance on the classification and conformity assessment procedures for standalone software. It requires manufacturers to demonstrate compliance with essential requirements and undergo an assessment process to obtain a UKCA or CE mark, indicating conformity with relevant regulations. The MHRA also emphasizes post-market surveillance and vigilance to ensure the ongoing safety and performance of standalone software.
IMDRF Software as a Medical Device:
The IMDRF, a global forum composed of medical device regulatory authorities, has also recognized standalone software as a distinct category of medical devices. The IMDRF defines software as a medical device (SaMD) as software intended to be used for one or more medical purposes, without being part of a hardware medical device.
The IMDRF framework focuses on risk-based classification and emphasizes a harmonized approach to regulating SaMD globally. It classifies SaMD based on its intended use, the criticality of the medical condition or decision, and the impact on patient health. The IMDRF provides guidance on the regulatory process, including clinical evaluation, validation, and post-market surveillance with the aim of regulatory converegence.
Similarities and Differences:
Although both the UK MHRA standalone software and IMDRF SaMD frameworks aim to regulate standalone software as medical devices, there are key differences between them. The primary distinction lies in the authoring bodies themselves, as the UK MHRA's guidelines are specific to the United Kingdom, even though the MHRA is now an IMDRF Management Committee member, whereas the IMDRF's guidance documents are intended to foster international regulatory convergence.
Additionally, the classification criteria for standalone software differ between the two frameworks. While the MHRA's risk classification is based on factors such as invasiveness and potential harm, the IMDRF's classification focuses on the intended use and impact on patient health. However, both frameworks highlight the importance of post-market surveillance and ongoing assessment to ensure the safety and effectiveness of standalone software.
As standalone software continues to play a crucial role in modern healthcare, it is essential to understand the regulatory frameworks established by the UK MHRA and the IMDRF recommendations. By utilizing these regulatory guidelines, manufacturers can navigate the complex landscape of standalone software regulation and contribute to advancing patient care through innovative digital solutions.
Trevor Klemann – Associate Medical Device Consultant