Understanding when software qualifies as a medical device is crucial to ensuring compliance with EU regulations — and ultimately, patient safety.
About this Guide
The rapid adoption of digital health solutions has brought software to the forefront of medical and healthcare applications. However, not all health-related software qualifies as a medical device. This guide explores when software is classified as Medical Device Software (MDSW) under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It breaks down classification frameworks, key guidelines, and risk-based classification rules to support medical software manufacturers in navigating compliance requirements.
Key Topics Covered
- Overview of MDR and IVDR regulations
- IMDRF guidance on Software as a Medical Device (SaMD)
- Classification rules and risk categories
- Practical examples of software qualification
- Comparison with FDA software regulations
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