Guidance Document on Medical Device Software under MDR-2017, 2026
AI / PRIVACY / CYBER RELEVANCE
Direct source for AI/ML medical software, clinical decision support and software safety/cybersecurity.
AI: Very HighPrivacy: HighCybersecurity: High
READ FIRST
- Sections on MDSW scope
- AI/ML software
- risk classification
- software lifecycle
- applicable standards
PURVIEW
Explains how software with a medical purpose may be treated and evaluated under the Medical Devices Rules, 2017 and provides practical regulatory guidance for medical-device software. Its purview includes classification, intended purpose, risk considerations and regulatory expectations relevant to software-based medical functionality. For privacy and cybersecurity, the document is useful for understanding why clinical AI requires both product-safety controls and protection of sensitive health data, even though the guidance itself does not replace the statutory Rules.
Classification and legal status. Guidance; not independent binding law. Regulatory requirements derive from the Act and MDR-2017.