Why Appointing the Right UK RP is
Critical for Compliance
Legal background
A competent UK RP is more than a legal placeholder; they are your frontline regulatory partner. Choosing the right UK Responsible Person (UK RP) is essential not only to fulfil legal obligations but to ensure smooth, secure, and long-term access to the UK market. An experienced and proactive UK RP will do more than just submit documents, they will act as your regulatory ally, keeping your operations compliant, your technical files audit-ready, and your communication with authorities efficient and professional.
An experienced UK RP will:
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- Ensure your device is correctly registered with the MHRA
- Maintain and make available your technical documentation for inspections
- Monitor regulatory changes and keep you compliant with evolving UK MDR requirements
- Serve as your direct contact point for UK authorities
Our services
How Obelis Supports Your Medical Devices in Great Britain
As your UK Responsible Person, we ensure your medical devices, IVDs, and custom-made devices meet all regulatory requirements to be placed on the Great Britain market. We handle MHRA registrations on your behalf, verify the completeness of your technical documentation, maintain essential records for inspection, and act as the official point of contact with UK authorities. Our experts keep you updated on UK MDR changes, support you in addressing compliance issues, and streamline your communication with importers. By choosing Obelis, you gain a proactive, reliable partner who ensures your products remain compliant and competitive in the evolving UK market.
FAQ
Frequently Asked Questions
A UK Responsible Person (UK RP) is a legal representative based in the UK who ensures that non-UK medical device manufacturers comply with the UK Medical Devices Regulations 2002. This includes registering devices with the MHRA and maintaining up-to-date technical documentation.
Yes. Since 1 January 2021, all non-UK manufacturers must appoint a UK Responsible Person to place medical devices, IVDs, and custom-made devices on the Great Britain market (England, Scotland, and Wales).
Only if they have been formally designated by the manufacturer. Without official designation, importers or distributors cannot legally fulfil the responsibilities of a UK Responsible Person under UK MDR 2002.
Products without a designated UK Responsible Person may be refused registration or removed from the market by the MHRA. This can also lead to legal liabilities, reputational damage, and disrupted market access.
