UK Responsible Person (UKRP) Services – Medical Devices & IVD Compliance
For medical device and In Vitro Diagnostic (IVD) manufacturers selling in the United Kingdom, appointing a UK Responsible Person (UKRP) is a regulatory requirement under the UK Medical Device Regulations (UK MDR). At MedTech Consultancy, we provide reliable UKRP services that ensure your device remains compliant with UK market requirements and regulatory obligations.
Whether you’re a global manufacturer entering the UK market or updating your regulatory strategy postBrexit, our UKRP support ensures your products meet all legal and compliance obligations.
What Is a UK Responsible Person (UKRP)?
A UK Responsible Person is a UKbased natural person or legal entity appointed by a nonUK manufacturer to act on their behalf in matters of UK regulatory compliance for medical devices and IVDs.
The UKRP acts as the official representative for devices placed on the UK market and is responsible for:
✔ Ensuring regulatory compliance under UK MDR
✔ Registering devices with the UK MHRA
✔ Maintaining technical documentation and declaration
✔ Communicating with UK regulators on behalf of the manufacturer
Without a designated UKRP, manufacturers cannot legally place medical devices or IVDs on the UK market.
Who Needs a UK Responsible Person?
UKRP services are mandatory for:
✔ Overseas manufacturers without a UKbased legal entity
✔ International companies entering the UK medical device market
✔ Organisations seeking to maintain compliance under UK MDR
✔ Manufacturers of medical devices and IVDs
If your headquarters are outside the UK, appointing a UKRP is required by law.
Key Responsibilities of the UK Responsible Person
A UKRP must:
Register Devices with the UK MHRA
Submit appropriate device registrations and keep them uptodate in compliance with UK MDR requirements.
Maintain Technical Documentation
Ensure the regulatory technical file is available for inspection by UK regulators and auditors.
Ensure Compliance with UK Requirements
Monitor ongoing compliance and changes in UK regulation that affect your device marking, labelling, or documentation.
Act as Primary Regulatory Contact
Interface directly with the UK Medicines and Healthcare products Regulatory Agency (MHRA) on compliance matters.
Our UK Responsible Person Services
At MedTech Consultancy, we offer comprehensive UKRP support tailored to your product portfolio:
UKRP Appointment
We act as your UK Responsible Person and fulfil all regulatory obligations as defined by UK MDR.
MHRA Device Registration
We prepare and submit your device registrations with the UK MHRA, ensuring accuracy and compliance.
Regulatory Compliance Monitoring
We monitor UK regulatory updates and keep your compliance status current.
Technical File Access & Maintenance
We ensure your technical documentation remains available and auditready for UK inspections.
Communication with UK Regulators
We handle official correspondence with the MHRA on behalf of your organisation.
Benefits of Our UK Responsible Person Service
🔹 Peace of mind for international manufacturers
You can operate with confidence knowing your UK regulatory duties are fulfilled.
🔹 Regulatory compliance assurance
Our team ensures you meet UK MDR requirements so your products remain legally placed in the UK.
🔹 Reduced administrative burden
We manage documentation, communication, and registration obligations on your behalf.
🔹 Ongoing compliance support
Stay uptodate with evolving UK regulations through dedicated support.
How It Works
- Initial consultation
Review your product portfolio and regulatory requirements. - UKRP appointment agreement
Formalise our role as your appointed UK Responsible Person. - Registration & documentation setup
Prepare and submit registrations, and organise technical documentation. - Ongoing compliance & monitoring
Keep your UK regulatory status continuously compliant.
Why MedTech Consultancy
✔ UKbased regulatory experts with deep knowledge of UK MDR
✔ Tailored support for multimarket manufacturers
✔ Efficient, transparent, and dependable service delivery
✔ Partnerfocused approach — regulatory obligations handled for you