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
Unlock critical insights into medical software qualification and ensure your software meets EU regulatory standards, Download the guide now
View our other resources and company news
Case Study Implementing a Site-Wide CPV Strategy to Strengthen Process Control
Blog Continued Process Verification (CPV) in GMP Manufacturing
Medical Device The Artificial Intelligence Act (EU 2024/1689) Whitepaper: Key Obligations, Risks, and Compliance
Guide When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide
Case Study Navigating DMF Registration in China with Rephine
Blog Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF
CSV Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation
Guide Understanding Intended Purpose in EU MDR & IVDR: Key Implications for Medical Device Manufacturers
Guide