Is Your Medical Device
EU AI Act Compliant?
Identify regulatory blind spots before the deadline. We bridge the gap between EU MDR and the new AI Act requirements for Software as a Medical Device (SaMD).
Why a Gap Assessment is Critical Now
The EU AI Act classifies most AI-enabled medical devices as High-Risk AI Systems. This introduces new requirements on top of your existing EU MDR obligations.
Double Regulation
Compliance with EU MDR does not automatically mean compliance with the AI Act. You need to align your Technical File and QMS to satisfy both regulations simultaneously.
Costly Penalties
Non-compliance penalties can reach up to €35 million or 7% of total worldwide annual turnover. Proactive assessment mitigates this financial risk.
Approaching Deadlines
With the AI Act entering into force, transition periods are ticking. Notified Bodies will soon require evidence of AI Act conformity for CE marking.
Our Comprehensive Assessment Scope
At NextGen MedTech, we don't just give you a checklist. We provide a deep-dive analysis of your current regulatory posture against the specific Articles of the EU AI Act relevant to medical technology.
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1. Classification & Scope Analysis
Determining if your software qualifies as a High-Risk AI System under Annex III and identifying prohibited practices.
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2. Technical Documentation Review
Analyzing your existing MDR Technical File against AI Act transparency, data governance, and logging requirements.
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3. Risk Management Integration
Evaluating your ISO 14971 Risk Management process to ensure it covers AI-specific risks (bias, autonomy, drift).
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4. QMS & Data Governance Audit
Assessing your Quality Management System (ISO 13485) for Post-Market Monitoring and data quality protocols.
Assessment Deliverables
Gap Analysis Report
Detailed clause-by-clause evaluation
Compliance Roadmap
Prioritized action plan with timelines
Documentation Templates
Updates for your Technical File
Typical Timeline
2 - 4 Weeks
Your Path to Compliance
Discovery
We review your existing Intended Purpose, MDR classification, and software architecture.
Audit
Our experts analyze your data governance, transparency, and human oversight mechanisms.
Reporting
We deliver a comprehensive Gap Analysis Report highlighting red flags and quick wins.
Remediation
We guide you through the QMS updates and documentation changes needed for certification.
Frequently Asked Questions
Ready to secure your market access?
Don't let regulatory uncertainty delay your innovation. Partner with NextGen MedTech for a precise, expert-led gap assessment.
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