u/Future_Bike_2524

Annex IV lists 10 mandatory sections. General description, development methodology, training data governance, performance metrics, risk management system, human oversight measures, transparency provisions, cybersecurity measures, and post-market monitoring plan.

For a large company with legal and compliance teams this is painful but doable. For a 10 person startup with an AI feature it is months of work or €20,000 to €50,000 in consultant fees.

Is there any regulatory guidance on proportionality? Has anyone actually been through the Article 11 documentation process and can share what regulators expect to see?

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u/Future_Bike_2524 — 21 days ago