AI in medical devices · Expert · 13 min lesson

Technical documentation for AI devices: what the notified body and FDA expect

Regulation (EU) 2024/1689 Articles 11 and 18 and Annex IV, MDR Annexes II and III, FDA PCCP guidance (December 2024), FDA draft AI lifecycle guidance (January 2025)

What you will learn

Explain how Article 11 and Annex IV of the AI Act combine with MDR Annexes II and III into one set of documentation, and which dates apply.
Describe what the FDA expects for the same evidence, including premarket content, the draft lifecycle guidance and predetermined change control plans.
Judge a documentation pack, spot inconsistencies and gaps, and answer a reviewer with controlled documents.

Key takeaways

Article 11(2): products under Annex I Section A keep a single set of documentation, with Annex IV content plus MDR content.
Annex IV has nine items; a cross-reference index to MDR Annex II and III makes the file reviewable.
Reviewers follow a claim to a signed, dated report, an independent dataset and a labelling procedure.
The FDA expects the same evidence through premarket content, the draft AI lifecycle guidance and a PCCP for planned changes.
Keep the file current with every release (Article 11(1), Annex IV item 6) and for ten years after placing on the market (Article 18).

Free practice question

Halden Retina's regulatory manager wants an 'AI Act file' kept by the data science team and an MDR technical file kept by quality, each in its own repository. Both describe the intended purpose, but the wording is already drifting.

What does Article 11 paragraph 2 of the AI Act expect?

Two separate files with separate owners.

Not quite. Article 11 paragraph 2 asks for one set of documentation for Annex I Section A products, so two files contradict it.

One set that contains the Annex IV information and the MDR information, with one index.

Correct. Article 11 paragraph 2 requires a single set combining Annex IV content with MDR Annex II and Annex III content.

The AI Act file alone, since it replaces the MDR file.

Not quite. Article 11 paragraph 2 adds to the device documentation and never removes MDR Annex II content.

No file until the application date of the AI Act.

Not quite. The MDR already applies, and Article 11 paragraph 1 requires the file before placing on the market.

Key terms

technical documentation: The file that demonstrates compliance, drawn up before placing on the market and kept up to date (AI Act Article 11; MDR Annex II).
Annex IV: The AI Act annex listing the minimum content of technical documentation for a high-risk AI system, in nine items.
single set: One combined body of documentation for products under Annex I Section A legislation (AI Act Article 11(2)).
datasheet: A structured record of a dataset: provenance, scope, selection, labelling and cleaning (Annex IV item 2(d)).
PCCP: An FDA plan, authorised with the device under FD&C Act section 515C, that defines planned modifications, how they are validated and their impact.
pre-determined change: A change planned and assessed at the first conformity assessment, which is not a substantial modification (AI Act Article 43(4)).
notified body: An organisation designated to assess conformity of devices under the MDR and, for these products, to check AI Act requirements.
GMLP: Ten guiding principles for good machine learning practice in medical device development, issued by regulators in 2021.

Official sources

Go further

The full lesson has narrated slides, more scenario questions with explained answers and a simulation.

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Illustrative example. Educational only, not legal advice.