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.
SaMD Compliance Toolkit
Deterministic MDR 2017/745 + AI Act 2024/1689 dual classification for Software as a Medical Device
Classify your software under MDR Annex VIII using the Rule 11 decision tree with MDCG 2019-11 Rev.1 (June 2025) guidance. Handles multi-rule interaction (Rules 3, 9, 10, 11, 22) with strictest-classification-governs logic.
- Class I / IIa / IIb / III determination
- Notified Body requirement assessment
- Modular SaMD support
Determine your AI system's risk level under the EU AI Act (Regulation 2024/1689). Automatic high-risk classification for AI SaMD requiring third-party conformity assessment under MDR.
- Article 6(1) / Annex I assessment
- Article 6(3) exemption analysis
- Article 50 transparency obligations
Generate structured technical documentation templates and EUDAMED registration checklists aligned with both regulatory frameworks.
- MDR Annex II tech doc template
- AI Act Annex IV tech doc template
- EUDAMED registration checklist
How It Works
This toolkit implements a 100% deterministic classification engine. No LLM or probabilistic components are used in the classification path. Every decision is traceable to a specific regulatory article, rule, or guidance document.
- Answer MDR questions — guided walkthrough of Rule 11 decision tree and multi-rule checks
- Answer AI Act questions — determine if AI Act applies and at what risk level
- Review dual classification — see combined obligations, overlapping requirements, and gap analysis
- Generate documentation — get structured templates for technical documentation and EUDAMED registration
Regulatory Basis
| Framework | Regulation | Key Provisions |
|---|---|---|
| MDR | Regulation (EU) 2017/745 | Annex VIII (Classification), Annex I (GSPRs), Annex II (Tech Doc) |
| MDCG Guidance | MDCG 2019-11 Rev.1 (June 2025) | SaMD qualification, classification, and prevention-purpose software |
| AI Act | Regulation (EU) 2024/1689 | Article 6 (High-risk), Annex I (Listed products), Article 50 (Transparency) |
Confidence Indicators
Clear-cut classification. Single applicable rule, well-established category.
Edge case or boundary condition. Multiple rules, prevention purpose, modular SaMD, or IVD data processing.
Complex case requiring expert review. Continuous learning AI, nanomaterials, multi-rule conflicts, or fully autonomous high-risk systems.