OPERON ELEVATEPLUS | UKCA MARKING FOR MEDICAL DEVICES
UKCA Marking & MHRA Medical Device Registration Services
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Operon ElevatePlus
UKCA Marking for Medical Devices Service Portfolio
UKCA Regulatory Strategy & Classification
Determine device risk class under UK MDR 2002
Assess conformity assessment routes depending on device type and risk
Technical Documentation Preparation
Prepare UKCA-aligned technical file
Evidence of safety, performance, and conformity requirements
Gap analysis against current CE technical files
MHRA Registration & Application Support
Complete support for MHRA device registration
Submission through the UK medical devices information system (MDIS)
Handling queries and compliance correspondence
UK Responsible Person (UKRP) Assistance
Appointment of UKRP for non-UK manufacturers
UKRP documentation and ongoing regulatory liaison
Conformity Assessment & UK Approved Body Support
Coordinate with UK Approved Bodies for assessment (required for higher-risk devices)
Audit readiness and conformity evidence support
Post-Approval Support & Ongoing Compliance
Post-market surveillance planning
Labeling updates and regulatory compliance monitoring
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
12+ Years of Global Regulatory Experience
200+ Successful Certifications & Registrations
Expert Support Across UK, EU, India & Other Markets
End-to-End Comprehensive UKCA Marking & MHRA Solutions
Operon UKCA Marking for Medical Devices Advantage
Complete regulatory support for achieving UKCA (UK Conformity Assessed) compliance and MHRA device registration, enabling market access in Great Britain
End-to-End UKCA Marking Support
Technical Documentation & MHRA Filing Expertise
Regulatory Strategy Aligned with UK MDR 2002
UK Responsible Person (UKRP) Support for Non-UK Manufacturers
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frequently asked questions
What is UKCA Marking for medical devices?
UKCA Marking is a UK conformity marking used for certain medical devices placed on the market in Great Britain. Medical device manufacturers must meet the applicable UK regulatory requirements and follow the relevant conformity assessment pathway before placing products on the market.
Is MHRA registration required for medical devices in the UK?
Yes. Medical devices must generally be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before they are placed on the Great Britain market. Manufacturers based outside the UK typically need to appoint a UK Responsible Person to complete registration-related responsibilities.
What is the difference between UKCA Marking and MHRA medical device registration?
UKCA Marking demonstrates conformity with applicable UK medical device requirements, while MHRA registration places the required device and manufacturer information on the UK regulatory register. Depending on the device and applicable transitional rules, manufacturers may need to meet both conformity assessment and registration requirements.
Do medical device manufacturers in Brazil need a UK Responsible Person?
Yes. A medical device manufacturer based in Brazil generally needs to appoint a UK Responsible Person (UKRP) when placing devices on the Great Britain market. The UK Responsible Person acts as the manufacturer’s local regulatory representative and supports communication with the MHRA.
Can CE-marked medical devices be sold in Great Britain?
Some CE-marked medical devices may continue to be accepted in Great Britain under applicable transitional arrangements. The acceptance period depends on factors such as the device type, applicable EU legislation, certification route, and relevant UK requirements. Manufacturers should verify the current rules before market entry.
Ready to Enter the UK Market with Your Medical Device
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