Medical Instrument Companies in the United Kingdom

Yes. The MHRA requires all medical devices, including IVDs, custom-made devices and procedure packs, to be registered before they are placed on the Great Britain market, whether they carry UKCA or CE marking. Only UK-based manufacturers can register directly; a manufacturer based outside the UK registers through its UK Responsible Person. A registration fee applies (MHRA guidance gives the current amount).

Registration is not an MHRA approval of the device. It puts the device and the responsible parties on record. When buying from a UK distributor, ask which UK Responsible Person or manufacturer registered the device, and check the marking route. See the medical certifications page.

Medical certifications

Not entirely. England, Scotland and Wales (Great Britain) follow the UK MDR 2002: devices carry UKCA marking or accepted CE marking and must be registered with the MHRA, with a UK Responsible Person for non-UK manufacturers. Northern Ireland applies the EU MDR (since 26 May 2021) and IVDR (since 26 May 2022): CE marking is required, a UKNI indication is added where a UK notified body did the assessment, and the MHRA is the competent authority.

The UKCA mark alone is not valid in Northern Ireland. GB-based manufacturers selling into Northern Ireland need an EU- or NI-based authorized representative. Listed UK companies can be found on the United Kingdom country page.

United Kingdom

No. In Great Britain, a manufacturer based outside the UK must appoint a UK Responsible Person (UKRP) in writing. The UKRP registers the devices with the MHRA, makes sure the declaration of conformity and technical documentation exist and are available to the MHRA, and passes on complaints and incidents. Importers and distributors do not need a UKRP of their own and are not the UKRP unless they are appointed as one.

Many overseas manufacturers appoint their main UK distributor as UKRP, but that ties the registrations to the distributor. Agree in writing what happens to the MHRA registrations if the relationship ends. For Northern Ireland, an EU or NI-based authorized representative is needed instead. See the medical certifications page.

Medical certifications

Strengthened post-market surveillance (PMS) requirements took effect in Great Britain on 16 June 2025 under SI 2024/1368. They apply to UKCA- and CE-marked devices alike. Manufacturers, supported by their UK Responsible Person, must:

• keep a PMS system and plan proportionate to the device's risk;
• report UK incidents to the MHRA and carry out field safety corrective actions;
• detect trends and produce periodic PMS or safety reports as their class requires.

Exact reporting timelines are in MHRA implementation guidance. For buyers, a supplier selling into the UK should be able to describe its complaint handling and incident reporting process. See the medical certifications page.

Medical certifications

Check these points for each product line, not just the company:

• Marking: UKCA, CE (accepted in Great Britain under current arrangements) or, for Northern Ireland, CE marking under EU rules.
• MHRA registration of the device, and who registered it (the UK manufacturer or the UK Responsible Person).
• The manufacturer's identity and the UKRP's details where required on labeling.
• Declaration of conformity and any Approved Body or notified body certificate covering the exact device.
• How the distributor handles complaints, recalls and incident reports.

The directory currently lists more than 40 companies in the UK, with city pages such as Sheffield. Listings are self-described and are not verification. See the United Kingdom country page.

United Kingdom