TamRx · Medical AI compliance
What documents do I actually need for my Medical AI?
Most changes touch more of the technical file than teams expect. TamRx turns your situation into a ranked, confidence-scored list of exactly which documents move and why.
Run this assessment free →The core technical file
A medical AI technical file typically spans the risk management file (ISO 14971), software documentation (IEC 62304), clinical evaluation (CER), post-market surveillance, usability and cybersecurity. AI Act high-risk status adds data governance and logging records on top.
Why documentation is interconnected
Change one module and the risk file, clinical evaluation and software artefacts usually move together. The skill is ranking by impact and gating which documents must be re-approved before release versus which follow as planned updates.
Frequently asked questions
What documents does a Class IIa medical AI need?
Typically a QMS, technical documentation including software lifecycle records, a risk management file, a clinical evaluation report, post-market surveillance and usability evidence — plus AI Act records if high-risk.
Does the AI Act add new documents on top of MDR?
Yes — most commonly data governance (Article 10) and automatic logging (Article 12) records, plus an AI literacy plan. Risk and technical documentation partly reuse existing MDR work.
Related
Decision-support only. AI-generated content may contain errors. Not legal or medical advice, and no guarantee of regulatory approval. Verify against primary legislation, guidance and qualified professional judgement before submission.