Most guides treat EU MDR 2017/745 as the manufacturer's problem. For a power-wheelchair importer, that's a costly assumption. Under the Medical Device Regulation, the importer and the distributor are named "economic operators" with their own legal duties. You are not a passive buyer who receives a CE-marked box — you are a check in the chain, and if that check fails, the liability and the held shipment land on you.
This guide is written for distributors and importers bringing folding power wheelchairs into the EU, not for patients and not as a general legal explainer. It covers what MDR is, what your role obliges you to verify, and the exact documents to get from your supplier before the first container moves. (For a plain overview of CE, ISO 13485 and UN38.3 alongside MDR, see our certifications guide — this one goes deeper into MDR specifically.)
What EU MDR 2017/745 actually is
EU MDR 2017/745 is the Medical Device Regulation that replaced the older Medical Device Directive (MDD 93/42/EEC) as the rulebook for placing medical devices on the EU market. A folding power wheelchair is a medical device in the EU, so it falls under MDR.
The mental model is simple: CE is the mark; MDR is the regulation that says how you're allowed to earn it, and who is responsible for what afterwards. Versus the old MDD, MDR tightened the rules on clinical evidence, technical documentation, traceability (via UDI device identifiers) and post-market surveillance — and, crucially for you, it spelled out duties for every operator in the supply chain, importers included.
Your role under MDR: the "economic operator" chain
MDR defines a chain of economic operators, each with obligations:
- Manufacturer — designs and makes the device, compiles the technical documentation, issues the Declaration of Conformity and applies the CE mark.
- Authorised Representative (EC REP) — an EU-based entity that a non-EU manufacturer must appoint to act for it on regulatory matters.
- Importer — the party that places a device from a non-EU manufacturer onto the EU market. This is you, if you bring the chairs in.
- Distributor — anyone further down the chain who makes the device available.
Why this matters: because the wheelchairs are manufactured outside the EU, MDR puts verification duties on you as importer before you place them on the market. In practice the importer is expected to confirm the device is CE-marked, that a Declaration of Conformity exists, that an EU Authorised Representative is appointed, and that labelling and UDI requirements are met — and to keep records. You don't author the technical file, but you must check the right pieces are in place and refuse goods that fail. If you private-label the chairs under your own brand, your obligations can rise toward the manufacturer's — clarify this early.
What you must verify — and who to get it from
Here is the practical checklist, mapped to what MDR expects and who supplies it:
| Under MDR you need… | What it is | Who you get it from |
|---|---|---|
| CE marking on the device | The market-access mark for the EEA | Manufacturer (applied at the factory) |
| Declaration of Conformity — per model | Manufacturer's signed statement that the model meets MDR | Manufacturer — confirm it names your model, not "the range" |
| EU Authorised Representative (EC REP) | EU-based rep for the non-EU manufacturer | Manufacturer appoints it; you record the details |
| Technical documentation access | The evidence file behind the DoC | Manufacturer / its AR, on request |
| UDI + compliant labelling | Device identifier + MDR label/IFU content | Manufacturer; you verify it's present on goods received |
| Post-market surveillance route | Defined channel for complaints / incident reporting | Manufacturer's system; you must pass issues back up |
| Importer details on the device/packaging | MDR requires the importer to be identifiable | You ensure your details accompany the product |
Read the table as two columns of action: things you collect and record (DoC, AR details, technical-file access) and things you inspect on the goods themselves (CE mark, UDI, labelling, your own importer information).
EU Authorised Representative: the non-negotiable one
This is the item importers most often miss. A manufacturer based outside the EU must have an EU Authorised Representative (EC REP) to place devices on the EU market under MDR. The AR is the manufacturer's regulatory point of contact inside the EU and shares certain responsibilities.
For you as importer, two things follow:
- Confirm the AR exists and is named before you import — ask for the AR's name and address, and check it appears where required on the labelling/documentation.
- Keep the AR on file. If a competent authority or a customer asks who the EU representative is, you should be able to answer immediately.
Per-model Declaration of Conformity — not "the range"
A Declaration of Conformity covers a specific model or model family, not automatically every chair a factory makes. A supplier can be genuinely MDR-compliant and still hand you a DoC that doesn't name the model in your order — and customs checks the document against the goods, not against the supplier's reputation.
So for each model you intend to import, confirm the DoC references EU MDR 2017/745 and names that exact model. If your range spans several models, you need the matching DoC for each.
UDI, labelling and post-market surveillance — in brief
You don't run these systems, but you must not break them:
- UDI — MDR requires a Unique Device Identifier for traceability; verify it's present and legible on what you receive.
- Labelling / IFU — MDR sets content rules for labels and instructions for use, and requires the importer to be identifiable on the device or packaging.
- Post-market surveillance (PMS) — the manufacturer must monitor devices in use; as importer you're expected to forward complaints and adverse-event information back up the chain and keep records. Have a route for this before you sell, not after a complaint.
The MDR document pack to request from any supplier
Whoever you buy from, ask for this set up front — and confirm each item per model:
- CE / EU MDR Declaration of Conformity — referencing EU MDR 2017/745 and naming the model
- EU Authorised Representative (EC REP) — name and address
- Technical documentation access — confirmation it exists and is available to the AR / competent authority on request
- UDI and MDR-compliant labelling / IFU — confirmation for the models you're importing
- Post-market surveillance / complaint-handling route — so you know where to send issues
- ISO 13485 certificate — current, in the manufacturer's legal name (the QMS behind the file)
If a supplier produces these cleanly, per model, you're dealing with a manufacturer that has placed devices on the EU market before. If the answers are vague, or "for the range," or the AR can't be named — slow down.
Where Wanderoll fits. Our folding power wheelchairs are manufactured in line with EU MDR 2017/745, and as an OEM / ODM partner we can prepare the CE / EU MDR documentation under your brand. EU Authorised Representative details and the per-model Declaration of Conformity are provided to verified buyers on request. As a top-10 Chinese manufacturer building on our own line, we'll walk the MDR pack with you model by model — so the paperwork matches the order before anything ships.
Importing folding power wheelchairs into the EU? Tell us your models and destination markets, and we'll send the MDR document pack — per-model Declaration of Conformity referencing EU MDR 2017/745, EU Authorised Representative details, and ISO 13485 — confirmed model by model. → Request a quote
