UKCA mark
for medical devices and IVDs
Marking for the placing on the market of medical devices
in the UK market
UKCA mark
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
- Device classification and conformity route identification under UK MDR 2002
- Preparation of UK Technical File aligned with MHRA requirements
- Review of labeling, IFU, and product claims (in English)
- Appointment and registration of UK Responsible Person (UKRP)
- MHRA database registration and device listing
- Liaison with UK Approved Bodies (where applicable)
- Vigilance, PMS, and post-market 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
Do you have products that require UKCA marking?
Fill out the form with your request.
We will contact you as soon as possible.
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