Mobility
CE, UKCA, FDA: four questions that separate a mark from a document
A logo wall is not a compliance file. Here is what a supplier should be able to name — directive, model scope, document number — before you commit a listing.
Every supplier page in this category shows badges. Almost none show a document number against a model. That gap is where importers get hurt: customs asks for the file, and the badge on the website does not answer.
1. Which directive does the CE mark come from?
A wheelchair can carry a CE mark under the EMC directive, under the machinery directive, or as a medical device under the MDR. These are different assessments with different paperwork. A certificate issued against EMC is a real document — it just does not make the product a certified medical device.
2. Does the certificate name your model?
Series certificates list model ranges. If the range on the document does not include the SKU you are buying, the document does not cover your shipment. Ask for the page where the model appears.
3. Is the FDA document a clearance or a registration?
An establishment registration and a 510(k) clearance are not the same thing, and repeating “FDA approved” on a marketplace listing is a compliance risk you inherit, not the factory. Ask for the document type, and the K-number if there is one.
4. Which ISO 7176 parts were tested?
Stability, braking, static strength and obstacle climbing are separate parts. “Passed ISO 7176” without part numbers is close to meaningless; the report number and the parts tested are what a tender reviewer wants.
What to send a supplier
One email: “Please send the declaration of conformity, the test report numbers and the model scope for [model], for [country].” A supplier who cannot answer within a day does not have the file.