EU MDR

What it requires

The EU MDR establishes a regulatory framework for medical devices placed on the EU market. Software, including AI-powered software, qualifies as a medical device when it is intended by the manufacturer for diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease. AI medical devices must meet the general safety and performance requirements in Annex I.

Key requirements for AI medical devices

• Annex I Chapter I: General requirements for safety and performance
• Annex I Section 14.2(d): Software lifecycle requirements for devices incorporating software
• Annex I Section 17: Software as a medical device (SaMD) specific requirements
• Annex II: Technical documentation structure and content
• Annex III: Technical documentation on post-market surveillance
• Annex XIV: Clinical evaluation and post-market clinical follow-up
• Article 83: Risk management system (linked to ISO 14971)
• Article 10: General obligations of manufacturers

How Vigilens automates it

Vigilens maps EU MDR essential requirements to executable controls in the AI development pipeline. For medical AI, this means tracking not just the software lifecycle, but the clinical evidence, risk management outputs, and post-market surveillance data that regulators and Notified Bodies expect.

• Annex I essential requirements mapped to pipeline-collectable evidence
• Design control evidence aligned with ISO 13485 Clause 7.3
• Risk management tracking linked to ISO 14971 requirements
• Clinical evaluation evidence and post-market surveillance linkage
• Technical documentation (Annex II) generated from live governance data
• Cross-mapped to EU AI Act for dual-regulated AI medical devices

EU MDR and the EU AI Act

AI-powered medical devices that qualify as high-risk under both the EU MDR and the EU AI Act face dual regulatory requirements. The EU AI Act's Digital Omnibus clarifies that existing sectoral legislation (including MDR) takes precedence where it overlaps, but AI-specific obligations in Articles 9-15 still apply. Vigilens maps both frameworks in a single governance record.