EU AI Act - System Classification Intake

AIML Partners

AI Machine Learning Partners Ltd. · CRO 809975

EU AI Act — System Classification Intake

Complete this questionnaire to initiate a risk classification assessment of your AI system under the EU AI Act (Regulation 2024/1689). Your responses will determine your system's risk tier, applicable obligations, and recommended compliance actions.

A4C001 · EU AI Act Compliance Manager

Section A — System identity

Name of the AI system *

Submitting organisation *

Organisation type *

Country of deployment *

Intended purpose *

Describe what the system does and who it is used by or about. Max 200 words.

Primary output type *

Decision (the system makes or triggers a direct action) Recommendation (the system advises a human decision-maker) Prediction or risk score Detection or classification Monitoring or alerting Administrative or operational output Other

Section B — Deployment context

Is this system used by or about patients or service users? *

Is this system used in a clinical or care setting? *

Does it directly influence clinical decisions, diagnosis, or treatment? *

Does it process special category personal data (health, biometric, genetic)? *

Is a qualified human always reviewing the output before any action is taken? *

Section C — System type screening

Is this a general-purpose AI model (e.g. GPT-4, Gemini, Claude, Llama)? *

Is this system certified as a medical device under MDR or IVDR? *

Is the system used purely for research with no direct patient or care impact? *

Has this system been placed on the EU market or put into service in the EU? *

Section D — Annex III screening

Select all that apply. These map to Annex III, Point 5 of the EU AI Act (health and safety of persons).

Assists in the diagnosis of disease, medical conditions, or mental health conditions

Assists in determining or recommending treatment, medication, dosage, or care pathways

Monitors patient vital signs, clinical status, or physiological parameters in real time

Triages patients or prioritises access to care or clinical resources

Predicts clinical outcomes, patient deterioration, readmission risk, or safety events

Manages, supports, or automates population screening programmes

Supports surgical planning, robotic assistance, or procedural guidance

Generates or interprets medical imaging (radiology, pathology, ophthalmology, etc.)

None of the above apply

Degree of human oversight in place

Section E — Submitter details

Your full name *

Job title / role *

Email address *

Preferred contact date / week

Important notice: This questionnaire is an AI-assisted governance intake tool. Submission does not constitute legal advice, regulatory approval, or conformity assessment. Classification outputs are advisory and must be reviewed with qualified legal counsel. AI Machine Learning Partners Ltd. accepts no liability for decisions made solely on the basis of this tool's outputs.