MHRA / UKCA Marking
UK regulator and post-Brexit conformity marking for medical devices in Great Britain.
Definition
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates devices in Great Britain under the UK MDR 2002 (as amended). UKCA marking will replace CE marking for the GB market on a transition timeline currently extended through 2030 for many device classes. Great Britain (England, Scotland and Wales) uses the UK Medical Devices Regulations 2002, while Northern Ireland follows EU rules under the Windsor Framework. Devices must be registered with the MHRA, and non-UK manufacturers need a UK Responsible Person. Legislation allows CE-marked devices to continue to be placed on the Great Britain market until 2028 or 2030 depending on device type and certificate, while the UK finalizes its new framework.What this means in practice
Northern Ireland continues to follow EU rules under the Windsor Framework, requiring CE/UKNI marks. UK Approved Bodies - separate from EU Notified Bodies - perform conformity assessments for UKCA.Examples
- A manufacturer of Class IIa surgical instruments currently holding a CE mark must ensure their devices will achieve UKCA marking by the extended deadline to continue being sold in England, Wales, and Scotland.
- A company based in the United States intending to market a novel implantable device in Great Britain must appoint a UK Responsible Person and obtain UKCA marking through a UK Approved Body.
- A quality manager is reviewing their company's regulatory strategy to ensure that all Class III devices have a valid UKCA certificate well in advance of the 2028 mandatory compliance date.
- •Failing to understand the extended transition timelines for UKCA marking can lead to non-compliance for devices placed on the Great Britain market.
- •Confusing the requirements for UKCA marking with CE marking, which applies in the EU and Northern Ireland, can result in incorrect conformity assessments.
- •Not engaging with a UK Approved Body for higher-risk devices requiring third-party conformity assessment under UKCA regulations is a common pitfall.
- •Assuming that a device with a CE mark can automatically be placed on the Great Britain market without considering any additional UKCA specific requirements, even during the transition period.
- •Overlooking the specific requirements for economic operators, such as UK Responsible Persons, when marketing devices in Great Britain under UKCA regulations.
Frequently asked questions
Cross-references
Often confused with
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMandatory European conformity mark for medical devices placed on the EU market.
Regulation (EU) 2017/745 governing medical devices in the European Union.
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MHRA Medical DevicesTier 2 VerifiedMHRAgov.uk
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.