Our company is preparing for the February 2, 2025, EU AI Act deadline. We are working on: • A statement confirming our SaMD avoids prohibited AI practices (Article 5). • A justification of our team's AI literacy (Article 4). What are some best practices or tips for documenting compliance or aligning with the AI Act? Any advice would be appreciated.

Ask a question

Technical Documentation Open question

Tips for documenting SaMD compliance with the EU AI Act (Articles 4 & 5)

Anonymous · Published September 17, 2025 · 1 comment

Our company is preparing for the February 2, 2025, EU AI Act deadline. We are working on:

A statement confirming our SaMD avoids prohibited AI practices (Article 5).
A justification of our team's AI literacy (Article 4).

What are some best practices or tips for documenting compliance or aligning with the AI Act? Any advice would be appreciated.

Join the discussion. Leave a comment. Guest comments are welcome — add your email to get reply notifications.

Svenja Hoffmann 9 months ago

Are you looking for practical document templates, or more general advice on evidence and justification?

Reply to this comment

Discussion

0 Answers

No answers yet. Be the first to reply!

Want to add your answer to this question?
Write an answer under your name by logging in or signing up, or post anonymously.

Keep reading

All questions

5:15

Free IEC 62304 Course: Documenting Software as a Medical Device (SaMD)

Dr. Oliver Eidel

1.4 K views · over 1 year ago

How to ensure user manual readability and usability during testing?

Anonymous

3 months ago

What are effective methods for ensuring that user manuals or Instructions for Use (IFUs) are readable and usable during testing? Are there recommended tools or formulas for assessing readability?

Accepted 10 answers

You should only consider hazards that are caused by software failure when assigning the software safety class under IEC 62304. Hazards caused solely b

Regulatory News

ISO 13485 Amendment, Templates, User Manuals

Updated over 1 year ago

Dr. Oliver Eidel

Still have a question? Ask a question here publicly — for free.

Or talk to one of our consultants — first calls are free. Check out our services and prices.

Looking to automate your regulatory work? Check out our eQMS, Formwork. Built for lean, founder-led companies. There’s a free version too.