Selecting the Right UK RP: Why It’s Essential for Compliance
Legal background
A qualified UK Responsible Person (UK RP) is more than a legal requirement under the UK Medical Devices Regulations 2002 (UK MDR 2002). For medical device, IVD, and custom-made device manufacturers, the right UK RP ensures MHRA compliance, supports ongoing regulatory obligations, and helps maintain reliable access to the Great Britain market.
How the right UK RP supports your compliance
Why choosing an experienced UK RP matters
MHRA registration
Ensures your medical device is accurately registered with the MHRA before entering the UK market.
Technical documentation
Maintains complete and inspection-ready technical documentation to support regulatory audits.
Ongoing UK MDR compliance
Monitors regulatory updates and helps ensure continuous compliance with UK MDR 2002 requirements.
Regulatory liaison
Acts as your dedicated contact with UK regulatory authorities, ensuring efficient communication and regulatory support.
Our services
How Obelis Supports Manufacturers Across Great Britain
Serving as your UK Responsible Person, we make sure your medical devices, IVDs, and custom-made devices satisfy every regulatory requirement needed for the Great Britain market.
We take care of MHRA registration on your behalf, check that your technical documentation is complete, keep essential records ready for inspection, and serve as the official contact for UK authorities.
Our team keeps you informed of changes to UK MDR, helps resolve compliance issues as they arise, and simplifies communication with importers. Partnering with Obelis UK means gaining a proactive, dependable ally who keeps your products compliant and competitive as the UK regulatory landscape evolves.
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Step 1
Appoint Obelis as your UK RP
We become your official UK Responsible Person, representing your company before the MHRA and UK authorities.
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Step 2
Review Your Documentation
We assess your technical documentation to ensure it meets UK MDR requirements and is ready for inspection.
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Step 3
Register Your Device
We complete your MHRA device registration and manage the required regulatory records on your behalf.
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Step 4
Stay Compliant
We provide ongoing UK MDR compliance support, regulatory updates, and communication with UK authorities to keep your products on the market.
Related Services
Compliance for Medical Devices in the United Kingdom
Frequently Asked Questions
Any manufacturer based outside the UK that wants to place medical devices, in vitro diagnostic devices (IVDs), or custom-made devices on the Great Britain market must appoint a UK Responsible Person (UK RP). Under the UK Medical Devices Regulations 2002 (UK MDR 2002), the UK RP is mandatory for products sold in England, Scotland, and Wales and acts as the manufacturer’s official representative for regulatory compliance and communication with the MHRA.
A UK Responsible Person (UK RP) acts on behalf of a non-UK manufacturer to ensure compliance with the UK Medical Devices Regulations 2002 (UK MDR 2002). Their responsibilities include managing MHRA device registration, maintaining and making technical documentation available for inspection, serving as the official contact for UK authorities, and supporting ongoing compliance as UK regulations evolve.
No. A UK Responsible Person and an importer have different legal responsibilities. While an importer may only act as the UK RP if they have been formally appointed by the manufacturer, the UK RP is specifically responsible for regulatory obligations such as MHRA registration, maintaining technical documentation, and liaising with UK authorities. Manufacturers should appoint an experienced UK RP to ensure full compliance and reliable market access.
Choosing an experienced UK Responsible Person like Obelis UK helps manufacturers go beyond meeting the minimum legal requirements. An experienced UK RP supports accurate MHRA registration, keeps technical documentation inspection-ready, monitors changes to the UK MDR, and provides ongoing regulatory guidance. This reduces compliance risks and helps maintain uninterrupted access to the Great Britain medical device market.