MHRA · UKCA / CE marking · UK Responsible Person
The United Kingdom is a high-standard, high-value market. Medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) under the UK Medical Devices Regulations 2002 (as amended post-Brexit).
Devices placed on the Great Britain market must carry a valid conformity marking — UKCA, with CE marking continuing to be accepted under transitional arrangements. Our manufacturers hold CE certification; we verify it per shipment. We do not self-certify — conformity rests with the manufacturer and their notified/approved body.
A manufacturer based outside the UK must appoint a UK Responsible Person (UKRP), who registers the devices with the MHRA before they are placed on the market. The UKRP is typically appointed by the importer/distributor. SWIFTSKY supplies the technical documentation the UKRP needs.
Honest note: A UK Responsible Person and MHRA registration must be in place before placing devices on the GB market. SWIFTSKY is a merchant exporter — we supply the manufacturer documentation; the UKRP appointment and MHRA registration are arranged by the buyer/importer.
| Item | Rate | Notes |
|---|---|---|
| Import duty — medical devices (general) | 0–4% | UK Global Tariff; many medical items are 0% |
| VAT | 20% | Standard rate; some medical supplies relieved |
| Port / clearance charges | Variable | Confirm with your customs broker |
Rates are indicative. Verify current commodity codes and reliefs with a UK customs broker before importing.
Our manufacturers hold CE certification, verified per shipment. We supply the documentation your UK Responsible Person needs for MHRA registration.