What is the role of Software as a Medical Device?

SaMD provides medical functions such as diagnosis, monitoring, or treatment, utilizing software algorithms, often on consumer devices.

Does SaMD require FDA approval?

Yes, when it meets the medical device definitions outlined in FDA guidance. Many Class II products require a 510(k) or De Novo submission, depending on the level of risk associated with them.

What is MDCG 2019‑11?

A non-binding but essential guidance endorsed by the MDCG clarifies how to qualify and classify SaMD under the EU MDR/IVDR.

How does cybersecurity impact SaMD compliance?

Strong cybersecurity, including secure coding, regular updates, and effective threat response, is crucial for obtaining pre-market approval and mitigating risk.

What are the challenges of Software as a Medical Device?

The main hurdles include defining intended medical use, managing continuous updates, gathering clinical evidence, and securing software against cyber threats, especially for AI SaMD.

How is Artificial Intelligence (AI) used in Software as a Medical Device (SaMD)?

AI SaMD powers diagnostic tools, predictive monitoring, and treatment suggestions. Because these systems can change with new data, they typically fall into higher regulatory classes, requiring more substantial evidence and risk control.