AI in medical devices · Expert · 13 min lesson

Capstone part 1: review of a fictional AI device file

MDR Annex I section 17 and Annex VIII Rule 11, ISO 13485 clauses 7.3.6 and 7.3.9, AI Act Articles 10 and 43(4), ISO 19011 clauses 6.4.7 to 6.4.9

What you will learn

Set and date the scope and criteria for an AI device file review, separating duties that apply now from those scheduled for later.
Read the file by area and trace one claim from the brochure to the raw data, spotting weak data splits, controls, criteria dates and change classes.
Log conformity, gaps and leads in a review matrix with document IDs so that findings can be graded in part two.

Key takeaways

Set the criteria first and date them; MDR duties apply now, while AI Act duties for Annex I products apply from 2 August 2028.
Read the index before the content; missing or mismatched documents are leads to verify, not findings.
Trace one claim from the brochure to the raw data; each link needs an identifier, a revision and a date.
In AI files check the data split, evidence that risk controls work, the date of the acceptance criterion and the change class of retraining.
Record conformity as well as gaps in the review matrix so that part two can grade by risk.

Free practice question

The founder of Ardent Imaging tells the reviewer: 'The AI Act has been postponed, so please leave it out of the NoduLens review.' The reviewer is building the criteria list for the file.

What is the best way to handle the AI Act in the criteria?

Delete it, because a postponed rule has no effect on the review.

Not quite. A postponement moves the application date under Regulation 2026/1744 and removes no duty, so deleting it hides readiness work for Article 6(1) devices.

Grade every AI Act article as a present nonconformity.

Not quite. Annex I products are covered from 2 August 2028 after the Omnibus, so a present grade would overstate the position under Article 113.

Keep a dated readiness section, and grade against the MDR and ISO 13485 that apply now.

Correct. The MDR Annex I section 17 applies today and AI Act duties come later, so both belong in the criteria with their dates.

Use only the FDA guidance, as it carries clear dates.

Not quite. The device is sold in the EU, so the MDR criteria in Annex I are the first to apply and cannot be replaced by US guidance.

Key terms

review matrix: A table with one row per area of the file: criterion, expected evidence, found evidence and status (conforms, gap or lead).
lead: Unverified information that points to a possible gap and must be confirmed by a record or observation before it becomes a finding (ISO 19011 clause 6.4.7).
data leakage: Information from the test data reaching training, for example the same patient in both sets, which inflates reported performance.
acceptance criterion: A measurable pass limit that is approved before the test is run.
PCCP: A plan agreed in advance describing the planned model changes, how they are tested and their limits (FD&C Act section 515C; FDA guidance, December 2024).
automation bias: The tendency of a user to trust an automated output too much and to check less carefully.

Official sources

Go further

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

Open the Academy Watch on YouTube

Illustrative example. Educational only, not legal advice.