United Kingdom
The United Kingdom is one of the main European markets for medical devices, with an advanced healthcare system and a strong demand for technological innovation.
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Regulatory Framework
The competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA).
Following Brexit, the UK has adopted the UKCA marking for Medical Devices.
Device classification:
- Class I: Low risk
- Class IIa, IIb: Moderate risk
- Class III: High risk
Specific Local Requirements
| Language | Documentation must be in English. |
| Local Representative (UK Responsible Person) | Mandatory for manufacturers based outside the UK. |
| Marking | Transition to UKCA marking, valid from 1st July 2025. |
Challenges and Operational Advice
- Brexit: The regulatory separation from the EU may cause uncertainties and slowdowns.
- Deadlines: The transition to UKCA requires early planning.
Why Choose ISEMED
- POST-BREXIT EXPERTISE
Support during the CE to UKCA transition. - TAILORED SUPPORT
Assistance in identifying a UK Responsible Person.
FAQ
- Is a local representative required? Yes, a UK Responsible Person is mandatory for companies based outside the UK.
- What language must the documentation be in? English.
- How long is the license valid? The first renewal date is 1 year after completion of the MHRA account application, and subsequently at least every 2 years.