Rehabilitation equipment for UK importers — MHRA and UKCA
Great Britain (England, Scotland, Wales) runs its own device regime under the MHRA, separate from the EU. Northern Ireland follows EU rules. That split alone causes more confusion than any other part of UK sourcing.
This page covers what our documents support and what your UK entity has to file.
How these products are classified
Walking aids, walkers, commode chairs, bath chairs and toilet rails are generally Class I under the UK Medical Devices Regulations 2002. The UK has extended recognition of CE marking for many device types, so a CE-marked Class I device can usually continue to be placed on the GB market — but MHRA registration of the device and the UK Responsible Person is still required, and the rules have moved several times, so confirm the position with your UK regulatory advisor for your product and date.
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 |
|---|---|---|
| UK Responsible Person (UKRP) appointment | You / your local entity | A UK-based entity must be appointed before devices can be registered. This is yours to arrange, not ours. |
| MHRA device registration | You / your local entity | Filed by the UKRP through the MHRA portal, per device. |
| UKCA or CE marking | We provide | We support both routes; tell us which your customer requires and we mark accordingly. |
| UK Declaration of Conformity | We provide | Separate from the EU DoC and citing UK regulations, with the UKRP named. |
| Instructions in English | We provide | UK requires English labelling and IFU; we supply the UK version of the artwork. |
| Post-market surveillance arrangement | Shared | Vigilance reporting routes through the UKRP; we supply the incident data we hold. |
How the goods get there
What usually goes wrong
- Assuming a UK distributor’s CE certificate covers MHRA registration — it does not, and unregistered devices can be seized.
- Confusing Great Britain with Northern Ireland, which still follows EU MDR.
Categories that move in this market
United Kingdom buyer questions
Is CE marking still accepted in Great Britain?
Do you have a UK Responsible Person?
Can the same production run serve the EU and the UK?
Other markets
Shipping to United Kingdom?
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.