UK MDR 2002: the MHRA's medical device regulations and who they apply to

What is the UK MDR 2002?

The UK Medical Devices Regulations 2002 are the law for placing a medical device on the market in Great Britain. A UK Approved Body assesses conformity for all but the lowest-risk devices, the manufacturer affixes the UKCA mark and registers the device with the MHRA, and the MHRA enforces the post-market rules once it is sold.

Since 16 June 2025 the regulations include post-market surveillance rules: a surveillance plan for every device, a PMS report or periodic safety update report by class, and serious incident reporting to the MHRA on set deadlines. Great Britain also accepts devices CE marked under EU law, and a further amendment to the pre-market rules is in draft. Northern Ireland follows the EU MDR.

Who does the UK MDR 2002 apply to?

Manufacturers placing a medical device on the market in Great Britain under a UKCA or CE mark, wherever the company is based, who register each device with the MHRA before it goes on sale

Manufacturers based outside the UK, who appoint a UK Responsible Person to register their devices and answer to the MHRA for them

Companies already CE marked under the EU MDR, who still meet the Great Britain post-market surveillance and serious incident rules for devices sold there

The regulations become urgent when a UK distributor asks for the MHRA registration, when the UK Responsible Person asks for the Great Britain surveillance plan, or when a UK Approved Body books the first audit.

THE UK MDR IN QUALIO

Qualio maps the UK MDR beside the EU MDR and ISO 13485 in the same library, so the Great Britain additions show as their own gaps

Qualio breaks the UK MDR down requirement by requirement and maps your procedures, design records, complaints, CAPAs and post-market surveillance records to it, beside the EU MDR and ISO 13485. Shared requirements are answered once, the Great Britain additions show as gaps with a recommendation, and Qualio reassesses whenever a record changes. Copilot drafts the procedure update and your team approves it. You export the evidence by requirement.

Post-market surveillance, MHRA registration and UK Responsible Person procedures as controlled documents, with training assigned on the effective date of every revision

Labelling changes, such as adding the UKCA mark or the UK Responsible Person's name, run through change control with the affected documents released together

Design controls read from Jira as the work happens, with the ISO 14971 risk file beside them, for the technical documentation a UK Approved Body assesses

Supplier files and supplier corrective actions, each held with the approvals behind it

Standards that apply alongside the UK MDR 2002

Medical devicesEU MDR: The EU regulation whose CE mark Great Britain accepts, and the law that applies to devices placed on the market in Northern Ireland
Medical devicesISO 13485: The quality management system standard most UK Approved Bodies audit against, and a designated standard in Great Britain
Medical devicesMDSAP: The single audit programme the MHRA has observed since 2021 and has said it intends to join as a full member
Medical devicesISO 14971: The risk management standard behind the safety requirements every device has to meet, from hazard to residual risk
Medical devicesIEC 62304: The software lifecycle an Approved Body expects to see when the device is, or contains, software

Guides and webinars for the UK MDR

Guide

UKCA marking pathway guide

Webinar

Webinar — Ultimate guide to placing a medical device on the UK market

Blog

MHRA's 2026 Devices Reform: What Changes and When

Questions about the UK MDR 2002

What is the UK MDR 2002?

The UK Medical Devices Regulations 2002 are the law for placing a medical device on the market in Great Britain. The MHRA enforces them. Manufacturers show conformity, through a UK Approved Body for all but the lowest-risk devices, affix the UKCA mark and register the device with the MHRA. Northern Ireland follows the EU MDR instead.

Is a CE mark still accepted in Great Britain?

Yes. CE marked devices can be placed on the market in Great Britain beside UKCA marked ones. In October 2026 the government confirmed it will keep recognising devices CE marked under the EU MDR long term, with the legislation to follow. MHRA registration, the Great Britain post-market rules and, for manufacturers outside the UK, a UK Responsible Person still apply.

What changed in the UK post-market surveillance rules in 2025?

From 16 June 2025 every device needs a post-market surveillance plan, Class I devices a PMS report and Class IIa and above a periodic safety update report. Serious incidents go to the MHRA within 15 days, 10 for a death or serious deterioration and 2 for a serious public health threat.

Do we need a UK Responsible Person?

Yes, if the manufacturer is based outside the UK. The UK Responsible Person registers the devices with the MHRA, keeps the declaration of conformity and technical documentation available to it, cooperates on corrective action and passes on complaints and incident reports. Their name and address go on the label, the packaging or the instructions for use.

Can we add the UK MDR 2002 to the standards we already run in Qualio?

Yes. Add it from the library and Qualio assesses the procedures, design records, complaints, CAPAs and post-market surveillance records you already hold against it, beside the EU MDR and ISO 13485 if you run them. Requirements they share count once, and the first assessment lists the Great Britain additions as their own gaps, with a recommendation on each.

When does the device go on sale in Great Britain?

Bring the date and your current procedures. We will show you the UK MDR assessed against them beside the EU MDR, the Great Britain additions listed and the evidence exported by requirement.

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