Export of medical devices to the UK – MHRA registration [2026]

Exporting medical devices (from plasters to CT scanners) is highly regulated. The UK no longer follows EU MDR. It has its own legislation (Medical Devices Regulations 2002).

Registration with MHRA

Every medical device placed on the UK market must be registered with MHRA (Medicines and Healthcare products Regulatory Agency). To do this, the foreign (Polish) manufacturer MUST appoint UK Responsible Person (UKRP).

Role of UKRP

UKRP is an entity based in the UK that:

• Registers your products with MHRA.
• It is the contact point for authorities.
• Stores technical documentation.

Without UKRP your goods will be held.

Marking

• Until 30 June 2028 (extended deadline), CE certificates are recognised in the UK.
• After this date, a full transition to UKCA.

What the current official guidance means in practice

For operational work, the current procedural rules, declaration fields and relief conditions should be checked directly against the official guidance. For this topic, the core reference points are European Commission, GOV.UK / HMRC.

Operational watch-outs

Most delays come from inconsistent data between the commercial invoice, packing list, tariff classification, reference numbers and transport assumptions. Before shipment release, confirm who is responsible for clearance, whether the data set is complete and when the declaration must be filed.

Documents and data to prepare

The minimum working pack worth preparing before speaking to customs support or filing a declaration includes:

• commercial invoice with a complete goods description
• packing list with quantities, weight and package count
• HS/CN code and origin information
• EORI number and the party responsible for the declaration

Practical notes for UK-PL operators

For regular flows, keep a stable data template: goods description, HS code, origin, Incoterms, carrier details and source documents. This shortens response time and reduces border corrections.

Official sources

• EU Commission (Customs procedures) — European Commission, 2026-03-04
• UK GOV (Importing into the UK) — GOV.UK / HMRC, 2026-03-04
• GOV.UK: Customs Declaration Service — GOV.UK / HMRC, 2026-03-04