SaMD Classification Wizard

Disclaimer

DRAFT — This is an indicative classification based on published EU regulations (MDR 2017/745, AI Act 2024/1689, MDCG 2019-11 Rev.1). It does not constitute legal, regulatory, or compliance advice. Consult your regulatory affairs team and/or Notified Body for definitive classification.

What This Tool Does

This wizard guides you through the classification of your Software as a Medical Device under both the EU MDR 2017/745 and the EU AI Act 2024/1689.

The classification follows these steps:

  1. MDR Classification — 10 questions based on Rule 11 decision tree and multi-rule checks
  2. AI Act Classification — 3 questions about AI/ML usage
  3. Dual Result — Combined classification with obligations, gap analysis, and recommended pathway

All classifications are deterministic. The same inputs always produce the same output. No AI or probabilistic models are used in the classification logic.