AI in medical devices · Expert · 13 min lesson

Vigilance, update release and communication for learning and static models

MDR Articles 2(65), 86 to 89 and Annex I section 23.4, EU AI Act Articles 43(4), 73 and 14, FDA PCCP guidance, 21 CFR 803 and 806

What you will learn

Decide whether an AI malfunction or drift is a serious incident or trend, apply the MDR reporting windows of 2, 10 and 15 days, and show the causal analysis in a record.
Separate locked, periodically updated and continuously learning models, and say which update route fits each: change control, notified body notification, AI Act predetermined changes or an FDA PCCP.
Build a release gate and a communication package with release notes, user instructions, rollback and field safety notice so that users know which model they are running.

Key takeaways

Version identity is device identity: log the model version with every output so that incidents, trends and recalls can be traced.
A possible serious deterioration is reportable under MDR Article 87 within 15, 10 or 2 days of awareness, and a late report costs more than an early one.
Article 88 trend reports need a baseline and method in the plan, and the PSUR under Article 86 must show model changes.
Locked models change through ISO 13485 clause 7.3.9 change control; learning models rely on predetermined changes under AI Act Article 43(4) or an FDA PCCP.
Every release needs a gate record, release notes, updated instructions under Annex I section 23.4 and a tested rollback.

Free practice question

Norvik is told that a patient whose wrist fracture was missed by the software needed surgery after displacement. The hospital cannot say which model version read the image, and Norvik has overwritten old versions. Norvik first learns of the event on a Monday.

What is the correct handling under the MDR?

Wait for a retraining study to prove that the model caused the miss.

Not quite. MDR Article 87 starts the clock at awareness and does not allow waiting for proof of the cause.

Treat it as a complaint and report it in the next PSUR.

Not quite. A possible serious deterioration meets Article 2(65) of the MDR and needs an Article 87 report, not a periodic mention.

Assess it as a possible serious incident, report within the Article 87 window, and record the missing version identity as a finding.

Correct. Articles 2(65) and 87 of the MDR apply to possible serious deterioration, and ISO 13485 clause 7.5.9 traceability gaps need correction.

Ask the hospital to submit the report.

Not quite. The duty to report belongs to the manufacturer under MDR Article 87.

Key terms

serious incident: An incident that led, might have led or might lead to death, serious deterioration of health or a serious public health threat (MDR Article 2(65)).
locked model: A model that does not change in the field and is replaced only by a new release from the manufacturer.
predetermined change: A planned modification, with its limits and methods, defined in advance and assessed with the original device.
substantial modification: Under the AI Act, a change after placing on the market that affects compliance or intended purpose and was not planned in the initial assessment.
field safety corrective action: An action taken by a manufacturer to reduce a risk linked to a device already on the market, announced by a field safety notice.
release gate: The set of conditions that must be met and recorded before a new model version is released to users.
rollback: Returning users to a previously verified model version after a problem with a new release.

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.