Rehabilitation equipment for EU importers under MDR 2017/745
Since MDR 2017/745 replaced the old directive, the importer carries obligations that used to sit with the manufacturer. Most first-time EU importers discover this after the goods arrive, when their distributor asks for a Declaration of Conformity that names the right entity and a technical file that actually matches the product.
Here is how the responsibilities split, and what we hand over so your file is complete.
How these products are classified
Walking aids, canes, walkers, rollators, commode chairs, shower chairs and toilet safety rails are typically Class I under MDR Annex VIII — non-sterile, no measuring function, not reusable surgical instruments. Class I devices are self-certified: no Notified Body is involved, and the manufacturer issues the EU Declaration of Conformity under its own quality system. That also means there is no Notified Body certificate to show you, which surprises buyers who expect one.
This is general guidance based on how these product types are normally regulated. Final classification for your exact product and claims is decided by your regulatory advisor or the authority.
Documents required, and who files each one
Most first-order delays come from a document nobody realised was the importer’s responsibility. This is the split.
| Document | Responsibility | Notes |
|---|---|---|
| EU Declaration of Conformity | We provide | Names the device, the class, the regulation and the manufacturer’s legal entity. Must match the label. |
| Technical documentation (Annex II & III) | We provide | Risk analysis, verification and validation, labelling, and the GSPR checklist. Must be available to the authority on request. |
| ISO 13485 certificate | We provide | Not strictly mandatory for Class I self-certification, but almost every EU distributor requires it in practice. |
| EUDAMED actor registration (SRN) | You / your local entity | You register as importer and obtain your SRN; we register as manufacturer and provide our SRN. |
| UDI (MDR) | We provide | Basic UDI-DI plus UDI-DI on the label and packaging, entered in EUDAMED. |
| Importer details on the label | You / your local entity | Your name, registered trade name and address must appear on the device or its packaging. |
| PRRC (Person Responsible for Regulatory Compliance) | We provide | A named qualified person available at the manufacturer; we provide the name and qualification on request. |
How the goods get there
What usually goes wrong
- Asking for a Notified Body certificate on a Class I device — there is not one, and a supplier who produces one is likely misstating the classification.
- Shipping before the importer’s SRN exists, which blocks the EUDAMED entries later.
- A Declaration of Conformity that lists a trading company rather than the legal manufacturer.
Categories that move in this market
Europe (EU) buyer questions
Do Class I rehabilitation products need a Notified Body?
Who registers in EUDAMED — you or us?
Can you put our company name and address on the label?
Which languages must the instructions be in?
Other markets
Shipping to Europe (EU)?
Send the product and destination. We reply in 24 hours with the document list for your market, the responsible party for each item, and an itemised FOB quote.