Predetermined Change Control Plans (PCCP) for AI/ML in Trial DHTs
Why an evolving on-device model needs a pre-agreed change plan — and why the regulatory timeline is the part most easily misjudged.
REGULATORY OPERATIONSAn evolving on-device model is designed to change — bound the changes, fix the method and acceptance criteria, and assess the impact before the study starts.
Every retraining or re-thresholding can alter what an endpoint records or a safety alert fires on; skipping the plan does not make the change unregulated, it leaves it uncontrolled. Design the envelope once, to the IMDRF / FDA three-component structure, and map it to each regime — do not assume a single global rule.
Which rule governs a model change depends on what the DHT is — a plan is authorized only for a current or future marketed device
| What the DHT is | Who authorizes the change plan | The rule |
|---|---|---|
| Trial-only DHT | No regulator — the sponsor's own change control | FDA DHT guidance: the DHT must remain fit-for-purpose so updates do not affect the measurements |
| Marketed AI-enabled device, US | FDA, via a PCCP in the marketing submission | FD&C Act s.515C; PCCP guidance final 4 Dec 2024, re-issued 18 Aug 2025 |
| Device with a high-risk AI system, EU | Notified body, at conformity assessment | AI Act Art. 43(4) pre-determined changes (MDCG 2025-6, Q30); MDR PCCP proposed in COM(2025) 1023 |
| Any market | Map onto the shared structure | IMDRF N90 (6 Aug 2026): description of modifications · modification protocol · impact assessment |
Four positions that turn unplanned change into planned change
Where the model is, or is a safety component of, a device, changing it changes the device; a marketed-device change affecting safety or effectiveness needs a new 510(k) or PMA supplement.
What is pre-authorized is exactly what the plan describes; a change outside the envelope, or one that cannot meet the plan's criteria, still needs a new submission.
A trial-only DHT runs its plan under the sponsor's change control; only a DHT that is, or will become, a marketed device can have the plan authorized by a regulator.
The US route is final; Regulation (EU) 2026/1744 moved the device-embedded high-risk obligations to 2 August 2028. A model across both markets sits under two change-control logics at once.
Six questions to answer before relying on an evolving model
- 1Bound the envelope — write down the foreseen modifications and their boundaries, and make what is out of scope explicit.
- 2Fix the method — a data-governance, training, testing and acceptance method every in-scope change must meet before deployment.
- 3Assess the impact of each change on safety, performance and any endpoint the model feeds, including its qualification.
- 4Record device status in the RIA — marketed or trial-only decides whether a regulator or the sponsor authorizes the plan.
- 5Operate inside the envelope — only conforming changes deploy, each logged in the Trigger Register; out-of-envelope change escalates.
- 6Make the plan visible — state the PCCP's existence and the changes made under it in labelling, as FDA's guidance recommends.
FDA PCCP guidance (Dec 2024, re-issued Aug 2025) · FD&C Act s.515C · FDA DHT guidance · 21 CFR 807.81(a)(3), 814.39 · IMDRF N90 (Aug 2026) · AI Act Art. 6(1), 43(4) · Reg. (EU) 2026/1744 · MDCG 2025-6 · COM(2025) 1023
© qointa 2026 – Public – Uncontrolled when printed · Not legal advice; this summary does not classify any device.
sales@qointa.com · qointa.com
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