Complete regulatory guide for Software as a Medical Device: definitions, market insights, regulatory challenges, and compliance strategies.
"Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
This independence allows SaMD to interface with various platforms while remaining an autonomous medical tool.
If the software powers a medical device's mechanics or is essential to its hardware operation, it is classified as SiMD (Software in Medical Device), not SaMD.
SaMD can diagnose conditions, suggest treatments, and inform clinical management in real-time.
SaMD applications can process massive amounts of complex clinical data in moments, offering unique advantages over traditional hardware.
The global SaMD market is witnessing exponential growth driven by smartphone adoption and AI innovation.
Software classification is complex. The same application may have different risk classifications in the EU versus the U.S. wording and intended use are critical.
The IMDRF provides guidelines for better convergence, covering technical documents on critical definitions, risk classification, QMS, and clinical evaluation.
SaMD must respect fundamental GDPR principles from the design stage. No user intervention should be required to ensure compliance.
Processing sensitive health data is generally prohibited unless exceptions under GDPR Article 9.2 apply:
Mobile Diagnosis Apps
Medical Image Analyzers
Clinical Decision Support
Remote Monitoring Platforms
AI Diagnostic Tools
Treatment Planning Software
Disease Risk Calculators
Personalized Medicine Algos
A sponsor needed a route to European market access for a platform facilitating medical prescription control and detection of iatrogenic risks.
We created a custom clinical and regulatory strategy that successfully allowed the sponsor to navigate the pathway and obtain the CE Mark under EU MDR.
Partner with Eclevar MedTech to develop your regulatory strategy, achieve CE marking, and successfully bring your Software as a Medical Device to market.
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