The document pack: what to request from a power-wheelchair supplier

A separate guide covers how to vet a supplier — the questions, the audit, the track record. This one is narrower: it's the list of documents to actually ask for, what each one proves, and how to check it isn't window-dressing.

A folding power wheelchair is a medical device that ships with a lithium battery, so the paperwork is part of the product. If a document is missing, expired, or doesn't name the model you bought, the shipment can be held at customs, refused by a freight forwarder, or thrown out of a tender — regardless of how good the chair is. The fix: ask for the full pack up front, and confirm each item per model. It's written for distributors and importers placing a first order — not for patients.

Request it as a "pack," not one document at a time

The biggest mistake is accepting one certificate and assuming the rest exist. A credible manufacturer can hand you the whole set cleanly; a trading layer usually produces it in pieces, vaguely, or "for the range only". So request the pack as a list, and treat how a supplier responds — speed and completeness — as part of your diligence. The pack falls into three groups:

• Compliance documents — proof the device and its factory meet the rules (ISO 13485, CE / EU MDR, UN38.3, test reports).
• Inspection / QC documents — proof your units were actually checked.
• Commercial documents — proof of what shipped, and from where (invoice, packing list, certificate of origin).

1. Current ISO 13485 certificate

ISO 13485 certifies that the manufacturer runs a controlled, audited quality system for designing, building and inspecting medical devices — it's one of the fastest ways to tell a real maker from an order desk.

How to check it's real:

• Confirm the certificate is current — read the expiry date; an expired or lapsed certificate is a red flag.
• Check the scope actually covers wheelchairs / powered mobility devices, not an unrelated product line.
• Note that it's issued in the manufacturer's legal name, which can differ from a brand or trading name — confirm it's the entity actually building your chairs.

2. CE / EU MDR Declaration of Conformity — per model

For the EU / EEA, CE marking is the legal precondition for sale, and behind it sits the manufacturer's Declaration of Conformity (DoC) under EU MDR 2017/745 — the medical-device rulebook.

The critical point, and the one that costs importers most: a Declaration of Conformity covers a specific model (or model family), not automatically every chair a factory makes — so a supplier can be genuinely certified and still hand you a DoC that doesn't name the model in your order.

How to check it's real:

• Confirm the DoC names the exact model you're buying — not just "the range".
• Check it references EU MDR 2017/745, not only the older directive.
• Ask whether the supporting technical documentation is available on request.
• If you're importing into the EU, confirm the EU authorised-representative details, since MDR assigns that role explicitly.

3. UN38.3 test summary — per battery

A lithium battery is dangerous goods for transport, and UN38.3 is the UN test standard it must pass to ship by air or sea. No valid UN38.3 test summary, and forwarders and carriers can refuse the battery.

One distinction to keep straight, because it trips people up:

UN38.3 means the battery is certified safe to transport. It does not, by itself, mean the chair can travel in an aircraft cabin. Cabin carry-on is a separate question that depends on the battery's watt-hours (Wh) and each airline's own rules.

How to check it's real:

• Ask for a separate UN38.3 test summary for each battery you import — different models use different batteries, so one summary rarely covers a mixed order.
• Match the cell / pack on the summary to the battery actually fitted to your model.
• Keep it on file as a freight document — it's what your forwarder and customs will ask for.

4. Test reports / EC certificate (where applicable)

Depending on the model and route, the technical file may include product test reports (for example, electrical-safety or EMC testing) and, for higher-class devices or certain routes, a certificate issued by a notified body. Not every chair needs every report, so ask which reports apply to the model you're buying rather than assuming a blanket set, and confirm any notified-body certificate is current and in the relevant scope.

5. Inspection & QC documentation

Certificates prove the system and the device design are sound; inspection records prove your units were actually checked. Ask how every chair is tested and what documentation you receive.

What to request:

• End-of-line / function-test records — evidence each unit was tested on the line before packing.
• Pre-shipment inspection — an inspection report (in-house or third-party) for your order.
• Video inspection — a recorded or live video check of your order before it leaves.

Wanderoll function-tests each chair on the line under an ISO 13485 quality system and offers video inspection per order.

6. Commercial documents

These travel with the goods and clear them through customs — distinct from the compliance pack, but just as able to hold a shipment if they're wrong.

What to request:

• Commercial invoice — values and terms for the shipment.
• Packing list — cartons, quantities, weights and dimensions.
• Certificate of Origin (CO) — proof of country of manufacture, often needed for customs and duty.
• Plus the transport paperwork your forwarder needs for a lithium-battery shipment (which is where the UN38.3 summary from §3 is used).

The document pack — at a glance

Request this set up front, and confirm each item per model:

Read it as three layers: compliance paperwork that proves the device and factory are legitimate, inspection paperwork that proves your units were checked, and commercial paperwork that clears the goods.

A note on the United States (FDA)

The US treats power wheelchairs as FDA-regulated medical devices, typically involving establishment registration and a 510(k) clearance where applicable. Be precise here, because US buyers can check the FDA's public databases in seconds. Wanderoll's FDA 510(k) is in progress — registration is underway, not yet cleared. We can support buyers on the US registration pathway, but until clearance is granted we make no claim of FDA clearance. For EEA-bound shipments this doesn't apply — there you work with CE / EU MDR.

How Wanderoll handles the pack

Wanderoll builds all ten models on its own line, so the documents come from the maker, not a reseller. Full certificates and test reports — ISO 13485, CE / EU MDR, and UN38.3 summaries — are released to verified buyers on request, with certification confirmed per model (the matching Declaration of Conformity for the model you're buying, not "the range") and a UN38.3 summary per battery configuration. Each chair is function-tested on the line under an ISO 13485 system, with video inspection per order, and CE / EU MDR / ISO 13485 paperwork can be prepared under your brand for OEM / ODM buyers.

If a supplier can produce this set cleanly, per model, you're dealing with a manufacturer that has done this before. If the paperwork is vague, expired, or "for the range only," slow down.

Tell us your destination markets and the models you're considering, and we'll send the matching document pack — ISO 13485, per-model CE / EU MDR Declarations of Conformity, UN38.3 battery summaries and inspection records — confirmed per model, plus our current FDA status in writing. → Request a quote