About SaMD Toolkit

Purpose

The SaMD Compliance Toolkit helps manufacturers of Software as a Medical Device (SaMD) navigate the dual regulatory landscape of the EU Medical Device Regulation (MDR 2017/745) and the EU AI Act (Regulation 2024/1689).

The classification engine is 100% deterministic — no large language models or probabilistic components are used in the classification decision path. Every classification outcome is traceable to specific regulatory articles, rules, and guidance documents.

Regulatory References

• MDR 2017/745 — Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
• MDCG 2019-11 Rev.1 — Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745, revised June 2025
• AI Act 2024/1689 — Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence
• MDCG 2020-1 — Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software
• ISO 13485:2016 — Medical devices — Quality management systems
• ISO 14971:2019 — Medical devices — Application of risk management to medical devices
• IEC 62304:2006+A1:2015 — Medical device software — Software life cycle processes
• IEC 62366-1:2015+A1:2020 — Medical devices — Usability engineering

Classification Logic

MDR Classification

The MDR classifier follows this decision path:

1. Determine if the software qualifies as a medical device (Article 2(1))
2. Check if the software drives or influences another device (MDCG 2019-11 Section 3.3)
3. Apply Rule 11 decision tree (Annex VIII, Chapter III, Section 6.3)
4. Check multi-rule interaction: Rules 3, 9, 10, 22
5. Apply MDCG 2019-11 Rev.1 special considerations (prevention purpose, IVD data)
6. Apply strictest-classification-governs principle
7. Score classification confidence (GREEN / AMBER / RED)

AI Act Classification

The AI Act classifier follows this decision path:

1. Determine if the software is an AI system per Article 3(1)
2. Check Article 6(1) — products under Annex I requiring third-party assessment
3. Check Annex III Category 5(b) — safety component in medical device
4. Evaluate Article 6(3) exemption conditions
5. Check Article 50 limited-risk transparency obligations
6. Default: minimal risk

Limitations

• This tool does not replace professional regulatory affairs advice
• Classification outcomes depend entirely on the accuracy of information provided
• The tool does not assess clinical evidence sufficiency
• EUDAMED-specific requirements may change as the system evolves
• National transposition measures and competent authority interpretations may affect final classification