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Devices for export only

Regulatory basis

Devices manufactured in the UK for export only — and not placed on the UK market — are not subject to the full requirements of the UK MDR 2002. However, the manufacturer remains subject to UK manufacturing quality standards and any requirements of the destination country's regulatory framework.

Devices for export only: what UK MDR 2002 does not require​

If a medical device is manufactured in Great Britain solely for export and is never placed on the UK market, the device does not need to:

  • Bear the UKCA mark
  • Be registered with MHRA as a device on the GB market
  • Comply with all aspects of UK MDR 2002 that are specific to GB market access

What still applies​

Even for export-only devices, the manufacturer must:

  1. Maintain a QMS — MHRA expects manufacturers operating from GB premises to maintain a Quality Management System to ISO 13485 regardless of whether their products are for UK or export markets
  2. Meet the destination country's requirements — the device must comply with the regulatory requirements of each country it is exported to (e.g., EU MDR for EU market, FDA requirements for the US, TGA for Australia)
  3. Meet any applicable UK legal requirements — including GMP requirements that may apply to the manufacturing premises

MHRA export certificates​

MHRA can issue Export Certificates (Certificates of Free Sale) for medical devices. These certificates confirm that a device is manufactured in the UK and is lawfully available on the UK market (or meets UK manufacturing standards). Export certificates are used by destination countries as part of their import authorisation process.

To obtain an MHRA export certificate:

  • Apply via the MHRA Submissions portal
  • The device must meet the eligibility criteria set by MHRA
  • A fee is charged

Export certificates are a service provided by MHRA — they are not a regulatory requirement under UK MDR 2002, but are frequently requested by overseas regulatory authorities.

Practical considerations for export-only manufacturers​

  • Regulatory affairs resource must cover destination market requirements — not UK MDR 2002 alone
  • Clinical data from UK clinical investigations may be accepted by overseas regulators (subject to their own assessment)
  • ISO 13485 certification from a UKAB may satisfy QMS requirements in many destination markets
  • MHRA registration as a manufacturer (entity registration, not device registration) may still be appropriate for establishing legal status with MHRA

Official references​

ReferenceDescription
UK MDR 2002General framework — including scope limitations for export devices
MHRA: Export certificatesMHRA export certificate service
ISO 13485:2016QMS standard — applicable regardless of market