UK Responsible Person (UKRP) Services For Medical Devices & IVDs
Helping overseas manufacturers achieve UK MDR compliance, MHRA registration, and seamless access to the UK medical device market with expert regulatory support.
MHRA Compliance
Expert support for UK medical device compliance and MHRA requirements.
UK MDR Guidance
Guidance for overseas manufacturers under UK MDR 2002 requirements.
Fast UKRP Setup
Quick UK Responsible Person appointment and onboarding support.
Market Access Support
Helping manufacturers place medical devices and IVDs on the UK market.
Our UKRP Process
1. Submit Documents
Provide necessary company and device information
2. Compliance Review
Our experts review your documentation for UK MDR compliance.
3. UKRP Appointment
We act as your UK Responsible Person.
4. MHRA Registration
We support your device registration and submissions to the MHRA.
5. Ongoing Support
We provide ongoing compliance and regulatory support in the UK.
Who Needs A UK Responsible Person?
Overseas manufacturers placing medical devices or IVDs on the UK market must appoint a UK Responsible Person to meet UK regulatory requirements.
Non-UK Manufacturers
Companies based outside the UK with no registered UK place of business.
Medical Device Brands
Manufacturers placing medical devices or IVDs on the UK market.
UK MDR Compliance
Support for meeting UK MDR 2002 and MHRA obligations.
Importers & Distributors
UK supply chain partners supporting compliant market access.
Why Manufacturers Choose Us
15+
Years of Regulatory Experience
100+
Global Manufacturers Supported
100%
Focus on MHRA Compliance
fast
Response & Dedicated Support
Frequently Asked Questions
How long does the registration process take?
MHRA registration timelines vary depending on device classification and documentation readiness. Most registrations are completed within a few working days once all required information has been submitted.
Which device classes are supported?
We support Class I, Class IIa, Class IIb, Class III medical devices, and IVDs requiring UK MDR and MHRA compliance support.
What documents are required for registration?
- Device description and intended use
- Risk management file
- Technical documentation or summary
- Declaration of Conformity
- Labelling and Instructions for Use (IFU)
- Quality management system evidence (where applicable)
- UDI information (if assigned)
Additional documents may be required depending on device class and whether MDR or IVDR applies.
How do I register on EUDAMED and MHRA?
We assist manufacturers with MHRA device registration requirements and provide guidance regarding EUDAMED obligations where applicable.
Do I need clinical evaluation reports (CER) for Class I devices?
Yes. All medical devices, including Class I devices, must have a clinical evaluation demonstrating safety and performance.
For many Class I devices, this can often be based on existing clinical data and scientific literature, rather than new clinical investigations.
What are my post-market surveillance obligations?
Manufacturers must maintain appropriate post-market surveillance systems, complaint handling procedures, vigilance reporting, and corrective action processes to remain compliant.