Your Device, and the System It Joins
A companion reading from the wearable / biosensor manufacturer seat — your own obligations, and the system the bridge creates
REGULATORY OPERATIONSYour device keeps its own obligations; the combination decides the data — and reliability is won or lost at the boundary with the hub.
Pairing with a phone, tablet or gateway transfers none of your classification, performance envelope or measurement claim. It puts a seam between your device and the hub, where pairing, transformation and timestamping happen. Document the interface, the performance envelope and the timing model, and pre-answer the bundling question.
Four facts decide whether your readings survive the crossing
Pairing does not move it. Where the combination has an intended purpose of its own, its class is assessed on its own footing.
Whether it is also an MDR system or procedure pack is a separate, conditional question under Art. 22.
Pairing, transformation and timestamping happen there. If the hub timestamps, time integrity sits with the hub, not you.
A measurement claim has to hold in the trial population — the point of the sponsor's verification and validation work.
Three arrangements quietly move the risk onto you
A standards-based profile — ISO/IEEE 11073, e.g. 11073-20601:2022 — is cheaper to evidence than a proprietary link, which can be validated but at a cost that lands downstream.
Where the phone or gateway stamps the reading, the automatic-capture requirement must be evidenced by whoever controls the hub — decide and declare which it is.
Under MDR Art. 22 the duty follows whoever combines the parts to place them on the market; EUDAMED actor registration has been mandatory for such producers since 28 May 2026.
Six disclosures turn the boundary from a liability into a selling point
- 1Publish a standards-based interface and an interface document a trial team can read and rely on.
- 2State your performance envelope — range, accuracy and the conditions under which the claim holds.
- 3Own the timing question — decide and declare whether your device or the hub timestamps readings.
- 4Bring real-population evidence, not just bench data, for the measure you claim.
- 5Pre-answer the bundling question — know whether a partnership makes you, or your customer, the Art. 22 producer.
- 6Name the transformations — any scaling, filtering or algorithm applied before data leaves your device.
EU MDR Art. 22 (incl. 22(4)), Arts 62, 74, 82 · 21 CFR Part 812 · EU computerised-systems guideline · ISO/IEEE 11073 family (11073-20601:2022) · EUDAMED actor registration
© 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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