Medical devices: software applications
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Latest change: Updated file 'Medical device stand-alone software including apps (including IVDMDs)' to reflect that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
AI Summary
This guidance document from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the regulatory framework for software applications classified as medical devices. Rather than focusing on a specific company or individual inspection dates, this document establishes industry-wide standards for all developers seeking to enter the UK market. The framework is designed to ensure that health-related software meets strict safety, quality, and performance criteria. Main violations or regulatory issues often stem from the incorrect classification of software based on its intended medical purpose or failing to distinguish between general wellness applications and regulated medical tools. For companies developing such technology, required actions include conducting a thorough classification assessment, implementing a robust quality management system, and adhering to legal duties for CE or UKCA marking. Failure to comply with these regulations can lead to market removal or legal penalties. The guidance emphasizes that manufacturers must maintain comprehensive technical documentation and perform ongoing post-market surveillance to track software performance and safety. This document serves as a comprehensive roadmap for innovation within the digital health sector while prioritizing patient safety through rigorous oversight and clear compliance pathways for developers.
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