UK Responsible Person For Medical Devices & IVDs
According to UK MDR 2019, the UK Responsible Person must be appointed to ensure compliance with the Medicines Health and Regulatory Authority guidelines for placing medical devices and Invitro Diagnostic devices in the United Kingdom.
UKRP Appointment
Usually 3-4 Working Days
MHRA Registration
Usually 4-6 Working Days
FSC & Apostille
Usually 6-8 Working Days
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What is a UK Responsible Person?
The UK Responsible Person is the UK equivalent of the EU Authorised Representative, the same concept, different market. When the UK left the EU, it introduced its own version of this role under UK MDR 2002 (amended by UK MDR 2019). If you previously had an EU Representative for the European market, the UKRP fills the same function for Great Britain.
In simple terms, the UKRP is the manufacturer’s legal point of contact with the MHRA. For any non-UK manufacturer, appointing one is not optional — it is a condition of market access.
To formalise the appointment, a mutually signed Letter of Designation must be in place between the manufacturer and the UKRP. This document confirms that the UKRP is acting with the manufacturer’s authority and that all devices placed on the UK market meet the applicable regulatory requirements. It must include the full legal name and address of both parties.
The MHRA first published guidance on the UKRP role in September 2019, ahead of Brexit, giving manufacturers time to understand and prepare for the requirement.
Why Choose I3CGLOBAL as Your UK Responsible Person
Choosing a UKRP is not just a compliance decision, it is a business and long term association. You need someone who responds quickly, understands your devices, and keeps your UK compliance active without you to chase. That is what we do.
GERMANY – INDIA – MALAYSIA – PORTUGAL –
SOUTH KOREA – UK – USA – VIETNAM
Who Needs a UK Responsible Person?
Any medical device or IVD manufacturer based outside the United Kingdom needs a UKRP before they can sell in Great Britain. It does not matter whether your device is Class I or Class III, CE marked or UKCA certified, a physical product or software — if you are not a UK-based business, you need one.
In practice, this means the vast majority of manufacturers approaching the UK market are affected. If you are based in India, China, the United States, Germany, or anywhere else outside the UK, the rule applies to you without exception.
There is one situation where it gets slightly nuanced — Northern Ireland. Manufacturers based in Northern Ireland do not need a UKRP to sell in Great Britain, because Northern Ireland is part of the UK. However, if you are selling into Northern Ireland itself, EU regulations apply and you need a European Authorised Representative instead.
Benefits of Working with I3CGlobal as Your UK Responsible Person
We are not a firm that added UKRP services to a list of offerings. Medical device regulatory work is what we do and have done since 1999, from our Global locations, for manufacturers across the world. Here is what that means for you in practice:
- Our team includes regulatory consultants, technical experts and auditors who have worked with complex devices across every class. If your device is complicated, we have seen something like it before.
- We cover the full picture not just UKRP and MHRA Registration, but UKCA technical documentation, clinical evaluation, biological evaluation, ISO 13485 implementation and certification body coordination.
- We identify the right GMDN code for your device at no extra charge a step many manufacturers get wrong and pay for later.
- We have access to associated laboratories for biocompatibility and safety testing across multiple countries.
- We are national representatives for four countries and support manufacturers in multiple currencies with flexible payment options.
- We are straightforward to work with. No unnecessary delays, no chasing, just a team that knows the process and gets it done.
Our clients do not just get a registered UKRP. They get a regulatory partner who understands their device, their market and what it actually takes to stay compliant in the UK long term.
Documents Required for UKRP Appointment
Getting your documents right from the start saves time. Here is exactly what your UKRP needs before registration can begin.
Declaration of Conformity (DoC)
- Manufacturer legal name and address
- Device trade name and model numbers
- Intended use statement
- Device classification under UK MDR 2002
- Applicable conformity assessment references
- Signature and date from authorised representative
- Applicable GMDN codes
Legal & Appointment Documents
- UKRP Letter of Designation / Appointment Agreement
- Manufacturer company registration certificate
- Authorised signatory details
Device Compliance & Technical Documentation
- CE or UKCA certificates where applicable
- Device labelling and IFU copies
- Technical documentation access arrangement for UKRP
- Clinical / performance evaluation documentation access
UK Responsible Person Requirements
The UK Responsible Person plays a critical role in ensuring that medical devices and Invitro diagnostic devices placed on the UK market comply with UK requirements. Here are the key roles and responsibilities of a UKRP.
- UK Responsible Person Ensure correct medical device classification followed
- Ensuring the manufacturer has considered the appropriate conformity assessment procedure
- Assure the manufacturer maintains the latest technical documentation and DOC
- Maintain a copy of the technical documentation, for inspection by the MHRA
- Provide MHRA with all the information and documentation necessary on request
- Coordinate with the manufacturer If any request for samples or devices from MHRA
- Cooperate with the MHRA on any CAPA action taken to eliminate potential risks
- Inform the manufacturer about field incidents & complaints in the shortest period
- Monitor manufacturer, if acts contrary to its obligations under MHRA Regulations
- Notify the MHRA and, if necessary, end UKRP contact with the manufacturer.
- Opening a single registration account on behalf of the manufacturers that we represent
- Support PMS activities
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UKRP for Medical Devices & IVD Devices
A UK Responsible Person is required for both medical devices and in vitro diagnostics (IVDs) the same rule applies to both product types under UK MDR 2002. Whether you manufacture surgical instruments, implantable devices, diagnostic reagents or point-of-care test kits, you need a UKRP in place before your products can be registered and sold in Great Britain. The device type changes the conformity route and documentation required, but the UKRP requirement itself does not change.
UKRP for Software Medical Devices
Software is regulated as a medical device in the UK if it meets the definition under UK MDR 2002 — and the UKRP requirement applies just as it does for physical devices. If your software qualifies as a Software as a Medical Device (SaMD), you need a UK Responsible Person before it can be made available to users in Great Britain — whether it is a standalone app, a cloud-based platform or software embedded in a hardware device.
The classification rules still apply. A low-risk SaMD may fall under Class I, while software that drives clinical decisions or controls a medical device can reach Class IIb or Class III. Your UKRP manages the MHRA DORS registration regardless of class — but the conformity documentation your UKRP holds will vary depending on where your software sits in the risk framework.
UKRP vs European Authorised Representative (EAR)
Already have an EU Representative? You still need a UKRP for United Kingdom. Already have a UKRP? You still need an EAR for the EU and Northern Ireland. The two appointments are independent, changing one does not affect the other.
| UK Responsible Person (UKRP) | European Authorised Representative (EAR) | |
|---|---|---|
| Market covered | Great Britain England, Wales and Scotland |
EU + Northern Ireland All 27 EU member states + NI |
| Regulation | UK MDR 2002 | EU MDR 2017/745 · EU IVDR 2017/746 |
| Regulator | MHRA | EU Competent Authorities |
| Must be based in | United Kingdom | European Union |
| Required for | Non-UK manufacturers | Non-EU manufacturers |
| Labelling requirement | UKRP name and UK address on GB label / IFU | EAR name and EU address on EU label / IFU |
| Registration system | MHRA DORS | EUDAMED |
| Can one replace the other? | No — both are required if selling in Great Britain and the EU / Northern Ireland. They are independent appointments. | |
Appoint a UK Responsible Person for devices registration. I3CGLOBAL supports for full compliance for medical devices and IVDs. Manufacturers in 30+ countries have appointed I3CGlobal as their UK Responsible Person. Request a proposal and find out how quickly we can get your device registered.
GERMANY – INDIA – MALAYSIA – PORTUGAL –
SOUTH KOREA – UK – USA – VIETNAM
Frequently Asked Questions
How to appoint a UK Responsible Personfor medical devices and IVD?
You can easily appoint I3CGLOBAL as your UK Responsible Person by making the annual fee and signing the contract in 3-4 working days.
Top rated UK responsible person service providers for regulatory compliance?
Can a UK Responsible Person help with MHRA registration?
Yes. The UKRP typically supports MHRA registration, regulatory communication, document coordination, and ongoing compliance activities for non-UK medical device manufacturers.
Does the UKRP name need to appear on device labeling?
Yes. For devices placed on the Great Britain market, the UK Responsible Person’s name and UK address must appear on the device labeling, packaging, or Instructions for Use (IFU) in accordance with applicable MHRA requirements.
Can one UK Responsible Person represent multiple medical devices?
Yes. A single UK Responsible Person may represent multiple medical devices or IVDs from the same manufacturer, provided the devices are properly registered with the MHRA.
Cost of hiring a UK responsible person?
The UKRP Cost for different class of devices provided in a different webpage. Please check for more details.