Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
MHRA
Register your medical device in the United Kingdom.
Obtain UKCA marking under the UK Medical Devices Regulations 2002 (as amended), with a mandatory UK Responsible Person and an Approved Body for Class IIa and above.
Speak to a specialistThe authority
Medicines and Healthcare products Regulatory Agency
MHRA
Since 2003
United Kingdom
An executive agency of the UK's Department of Health and Social Care, responsible for regulating medicines, medical devices and blood products in Great Britain (England, Scotland and Wales). Northern Ireland follows the European Union's MDR/IVDR regime under the Windsor Framework.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk, generally self-declared | Bandages, gauze, basic instruments |
| Class IIa | Low-to-moderate risk, requiring an Approved Body | Contact lenses, diagnostic equipment |
| Class IIb | Moderate-to-high risk, requiring an Approved Body | Infusion pumps, surgical equipment |
| Class III | High risk, requiring an Approved Body and intensive clinical review | Cardiac implants, prostheses, valves |
Registration process
How we manage your project
- 01
UK Responsible Person2 weeks
Appoint a UKRP (UK Responsible Person) with a UK address (mandatory for foreign manufacturers)
- 02
Classification2-4 weeks
Determine the class under the UK MDR (aligned with the European MDR)
- 03
ISO 13485 QMS4-8 months
A quality management system certified to ISO 13485
- 04
Technical dossier3-6 months
Document conformity with the Essential Requirements and UK MDR
- 05
Approved Body (Class IIa and above)4-8 months
QMS audit and dossier review by a UK Approved Body
- 06
UKCA marking and MHRA registration1-2 months
Apply UKCA marking and register the device with the MHRA through DORS
Total timeframeClass I: 2-4 months. Class IIa/IIb: 8-14 months. Class III: 14-20+ months
Local representativeUK Responsible Person (UKRP)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | The MHRA Yellow Card scheme for adverse events, Vigilance Reporting and PMCF |
| Renewal | Renewable five-year Approved Body certificate; ongoing MHRA registration |
| Required QMS | ISO 13485 and UK MDR Essential Requirements |
How HSC helps
The United Kingdom in 8 to 14 months, with a dedicated UKRP and the right Approved Body.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about MHRA
Next step
Ready to start your project in the United Kingdom?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist