UK is Regulated under the Medical Devices Regulations by MHRA (UKCA marking required). Great Britain (England, Scotland, Wales) Falls under MHRA regulations — CE marking accepted until June 2030, UKCA required thereafter. Northern Iceland Aligned with EU
| Regulatory Authority | Medicines and Healthcare products Regulatory Agency (MHRA) |
|---|---|
| Regulatory Authority Website Link | Click Here |
| Device Classification | I, IIa, IIb and III |
| Medical Device Regulations | EUMDR-2017/745 | Click Here |
| Registration Process | Register medical devices to place on the market | Click Here |
| Registration Timeline | MHRA takes 5 working days to review the application. |
| Conformity Assessment Route |
Medical devices: conformity assessment and the UKCA mark | Click Here |
| Requirement of Authorized Representative | Yes |
| Language Requirement | Labels must be in English Language |
| Labeling Requirements |
Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under. Devices placed on the Northern Ireland market must meet EU labelling requirements. |
| Clinical Trials Information |
Notify the MHRA of your intention to carry out a clinical investigation for medical devices. | Click Here |
| Software Guidance Document |
Guidance Software and artificial intelligence (AI) as a medical device | Click Here |
| Database | Public Access Registration Database (PARD) | Click Here |
| Fees for Submission |
Medical Devices: fees | Click Here |
| Post Market Surveillance |
Post-market surveillance (PMS) requirements for medical devices in Great Britain. | Click Here |
| Adverse Event Reporting Timelines | Serious incidents must be reported immediately, not exceeding 10 days after the manufacturer becomes aware of the event. Less serious incidents should be reported within 30 days. |
| Field Safety Corrective Action |
Field safety notices: guidance for manufacturers | Click Here |
| Additional Information | Great Britain-based authorised representatives are no longer recognised in the EU. This means that they are not able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market. If you are a manufacturer based in Great Britain or another country outside the EU, you must appoint an authorised representative based in the EU or Northern Ireland if you wish to supply devices to the EU market. |
| Contact Phone | 020 3080 6000 |
| Contact Email | info@mhra.gov.uk |