Vigilance and Post-Market Surveillance for Trial DHTs
Why the reporting route turns on what the device is — and why meeting one route never discharges another.
REGULATORY OPERATIONSA DHT does not shed its obligations once deployed — but which reporting route it carries turns on what the device is in that study.
Settle the position first; the route, the reporter and the clock follow from it. Hold one safety plan that records each device's position, names the legal reporter for every applicable route and prints the deadline that attaches to it. Closing an event under the protocol does not close it under vigilance.
Four positions, not two regimes; in one the Regulation swaps the route
MDR Arts 62–82; 21 CFR 812. Deficiencies and serious adverse events reported under Art. 80 or 21 CFR 812.150.
Within intended purpose, Art. 80(5)–(6) routes the sponsor to vigilance (Arts 87–90), not Art. 80 — one route.
Trial safety reporting (CTR Arts 41–42; 21 CFR 312.32) and manufacturer vigilance run at once — two clocks.
Most trial phones, tablets, gateways and eCOA apps. No device reporting duty — a conclusion to document.
Obligations stack — except where the Regulation displaces one
Protocol adverse-event reporting does not satisfy device vigilance, and a manufacturer's post-market surveillance does not cover an investigational device's deficiencies.
A cleared wearable capturing an exploratory measure keeps its manufacturer's vigilance duties while trial safety reporting covers participant harm. Both run; make the interface explicit.
Kitting, provisioning and import can place manufacturer, importer or distributor reporting duties (MDR Arts 13, 14 and 16) on a party that never signed up for them.
Capture, classify against the device's position, route to the right reporter and start the clock at awareness, act on FSCA, feed back into change control and decommissioning.
Six readiness moves, from device position to lifecycle feedback
- 1Settle each device's position — under investigation, PMCF within intended purpose, a tool in a medicinal-product trial, or not a device.
- 2Name the legal reporter for each route in contracts and the safety plan, including duties inherited through kitting or import.
- 3Record the clock for every route — which deadline applies, from what moment of awareness, and who holds it.
- 4Stand up capture and triage, including telemetry that surfaces silent failures, with a documented triage decision behind every signal.
- 5Pre-agree FSCA mechanics — who issues notices, how, and how reach to the field is evidenced.
- 6Wire feedback into change control, the validated state and decommissioning at study close.
MDR Arts 62–82, 80(5)–(6), 83–92 · CTR Arts 41–42 · 21 CFR 812.150 · 21 CFR 803 · 21 CFR 312.32 · ISO 14155:2020 · SI 2024/1368 reg. 44ZH · SI 2025/538
© 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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