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MHRA updates device registration guidance for Great Britain and Northern Ireland markets

🇬🇧 MHRA · Wed 11 Nov 2026

The agency's refreshed page sets out who must register devices before market placement, with EUDAMED now replacing MHRA registration for most Northern Ireland devices.

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on registering medical devices on 11 November 2026. The page, first published on 31 December 2020, covers the Great Britain and Northern Ireland markets. The source does not itemise what changed in this latest revision.

In Great Britain, all medical devices must be registered with the MHRA before being placed on the market. That includes in vitro diagnostic devices, custom-made devices and systems or procedure packs. Devices must conform to the Medical Devices Regulations 2002 as they apply in Great Britain. Registration is not an accreditation, certification, approval or endorsement by the MHRA, and manufacturers may not claim otherwise or use MHRA logos in marketing, packaging, instructions for use or other documentation.

Manufacturers based outside the UK must appoint a single UK Responsible Person, who takes on the manufacturer's registration duties. The guidance notes that DORS accounts of former Great Britain-based Authorised Representatives who had not updated their role to UK Responsible Person by 30 March 2026 are now closed. A statutory fee may apply per application when registrations are changed. The MHRA may also request technical documentation to demonstrate conformity.

The page also explains discontinuation. Registration must be maintained while a device is still made available in Great Britain, but is no longer required once no further product is placed on the market. Post-market surveillance and vigilance obligations continue for devices already on the market. Devices that are only put into service, such as those made and used within a hospital, are encouraged but not required to register.

For Northern Ireland, the page states that since 28 May 2026 all devices other than custom-made devices must be registered on EUDAMED before placement on the EU and Northern Ireland markets, and MHRA registration has not been required from that date. Custom-made devices need not be on EUDAMED and must still be registered with the MHRA within 28 days of being made available on the Northern Ireland market, under the Medical Devices (Northern Ireland Protocol) Regulations 2021. Great Britain-based manufacturers still need an EU- or Northern Ireland-based Authorised Representative for that market.

What it means for your team

  • Check that registrations in the MHRA system are accurate and current, and that UK Responsible Person arrangements are in place for non-UK manufacturers.
  • For Northern Ireland, standard devices now go through EUDAMED rather than the MHRA, while custom-made devices stay with the MHRA on a 28-day deadline.
  • Review whether each product is placed on the market, put into service, or both, as this determines whether registration is required.
  • When discontinuing a device, plan to unregister it per the Device Registration Reference Guide, while keeping vigilance and post-market surveillance running for units already supplied.

Official source: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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