A medical device is not one object. It is an object plus the file that says what it is, who made it, to what standard, and who is answerable if it fails. Customs authorities, hospital biomedical departments and insurers all read that file, and they read it after the equipment has arrived — which is the worst possible moment to find out it is incomplete.
The file is not long. For most classes of equipment it is five documents, and a supplier who cannot produce all five within a working day is telling you something about how they run their plant.
The five documents
- Declaration of Conformity. A signed statement from the legal manufacturer that the device meets the requirements of the regime it is marked under. It names the device, its classification, the directive or regulation, and — for anything above the lowest risk class — the notified body and its four-digit number.
- The certificate behind the marking. A CE certificate issued by a notified body, or an FDA 510(k) clearance, or the national registration certificate. The declaration references it; you want the certificate itself, in date, with the device on it by name.
- Quality-system certificate. Normally ISO 13485. This is about the factory, not the device: it says the plant runs a medical-device quality system that someone audits.
- Technical file summary. Intended use, classification rationale, essential-requirements checklist, risk-management summary to ISO 14971, and the standards applied — IEC 60601 for electrical medical equipment, ISO 10993 for anything with patient contact.
- Instructions for use and service documentation. In a language your biomedical team reads, with the service manual, the calibration procedure and the spare-parts list.
The three that go missing
In our experience the declaration and the IFU almost always arrive. What goes missing is the certificate behind the marking, the calibration record, and the service documentation — in that order.
The certificate goes missing because a supplier is quoting a device that is marked but is not on the certificate they hold, or whose certificate lapsed when the regime changed. Ask for the certificate as a PDF and check three things: the manufacturer name matches the one on the invoice, the device model is listed, and the expiry date is in the future.
The calibration record goes missing because the unit was calibrated at the factory and the record stayed there. For anything that measures — a monitor, an analyser, an infusion pump — that record is the baseline your team will be re-verifying against for the life of the device. Without it, the first service visit starts by inventing one.
Service documentation goes missing because it is treated as a commercial asset. Some manufacturers genuinely will not release a full service manual to anyone outside their authorised network. That is a legitimate business model and a legitimate reason to buy a different device: a hospital that cannot service a unit is buying a subscription, not equipment.
A supplier who cannot produce all five documents within a working day is telling you something about how they run their plant.
Ask before the purchase order, not after
Every one of these documents exists before the equipment ships. There is no technical reason for any of them to arrive later than the quotation, and asking for them at quotation stage costs nothing and filters a surprising number of intermediaries out of the process — an intermediary who has never held the file usually cannot get it.
Our own rule is that a purchase order does not go out until the file is complete and read. It slows the first order with a new supplier by about a week. It has never once slowed the second.