UKCA Mark for Medical Devices and IVDs
Marking for the placing on the market of medical devices in the UK market
UKCA Marking for Great Britain
Following Brexit, medical devices must comply with UK MDR 2002 (as amended) and display the UKCA mark to be marketed in Great Britain (England, Scotland, Wales).
ALTRION, through its UK Responsible Person (UKRP) office, provides complete regulatory representation and documentation services for UKCA compliance.
Our Services
Regulatory Classification
- Device classification and conformity route identification under UK MDR 2002
Technical Documentation
- Preparation of UK Technical File aligned with MHRA requirements
Labeling & Documentation Review
- Review of labeling, IFU, and product claims (in English)
UK Responsible Person (UKRP)
- Appointment and registration of UK Responsible Person
MHRA Registration
- MHRA database registration and device listing
Conformity Assessment
- Liaison with UK Approved Bodies (where applicable)
Post-Market Activities
- Vigilance, PMS, and communication with MHRA
- Periodic updates and renewals according to MHRA guidance
Why Choose Altrion
- Direct presence in the United Kingdom
- Combined experience in EU and UK regulatory frameworks
- Fast and reliable registration process with MHRA
- Fixed-fee representation ensuring independence from distributors/importers
Deliverables
- UKCA Technical File and Declaration of Conformity
- MHRA registration confirmation and UKRP appointment letter
- Annual vigilance and PMS reports
- Audit and inspection support
Contact Us
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