UKRP & MHRA Registration Service for Medical Devices and IVDs
Manufacturers based outside the UK need a UK Responsible Person to sell medical devices and IVDs in Great Britain. We act as your UKRP, register your devices with the MHRA and handle communication with the regulator for CE and UKCA marked products.
What is a UK Responsible Person?
A UK Responsible Person (UKRP) is a person or company established in the UK that a non-UK manufacturer appoints to act on its behalf for regulatory tasks under the UK Medical Devices Regulations 2002.
Without a UKRP, an overseas manufacturer cannot register devices with the MHRA or place them on the Great Britain market, whether they carry CE or UKCA marking. The UKRP is the MHRA's first point of contact for your devices.
What your UK Responsible Person does
The UKRP's tasks are set out in the UK MDR 2002 and MHRA guidance, and agreed with you in writing.
| Task | What it means for you |
|---|---|
| Verify documentation | Checks that your Declaration of Conformity and technical documentation exist and that the right conformity assessment was carried out. |
| Keep copies available | Holds copies of the technical documentation, Declaration of Conformity and certificates for the MHRA. |
| MHRA registration | Registers your devices with the MHRA and keeps the registration current. |
| MHRA requests | Provides information, documents and samples to the MHRA on request. |
| Corrective actions | Cooperates with the MHRA on preventive and corrective actions. |
| Complaints & incidents | Forwards complaints and reports of suspected incidents to you immediately. |
| Terminate if needed | Ends the arrangement if you act against your obligations, and informs the MHRA. |
How we become your UK Responsible Person
A simple onboarding route from first contact to devices registered and on the GB market.
- 1
Scope & document review
Week 1We confirm your devices, classes and certificates and review your Declaration of Conformity and technical documentation.
- 2
UKRP agreement
Written mandateWe sign an agreement that sets out our tasks and your obligations.
- 3
MHRA account & registration
MHRAWe set up the MHRA account and register your devices.
- 4
Labelling check
UKCA or CEWe check that labels and IFU carry the required UKRP and UK details.
- 5
Ongoing representation
LifecycleWe handle MHRA requests, forward complaints and incidents and support corrective actions.
- 6
GB post-market surveillance
GB PMS rules 2025We support PMS reporting and serious incident timelines for devices on the GB market.
UK Responsible Person vs EU Authorised Representative
Selling in both the EU and Great Britain? You need both roles, filled by entities based in each market.
| UK Responsible Person | EU Authorised Representative | |
|---|---|---|
| Market | Great Britain | EU (and Northern Ireland) |
| Legal basis | UK MDR 2002 | EU MDR / IVDR Article 11 |
| Must be based in | The UK | The EU |
| Regulator | MHRA | National competent authorities |
| Registration | MHRA device registration | EUDAMED actor (SRN) and device registration |
Our UKRP and MHRA services
UK Responsible Person FAQs
Who needs a UK Responsible Person?
Any manufacturer based outside the UK that places medical devices or IVDs on the Great Britain market must appoint a UK Responsible Person (UKRP). This applies to both CE-marked and UKCA-marked devices.
Can my EU Authorised Representative act as my UKRP?
Only if it is also established in the UK. The UKRP must be a person or company based in the UK, so an EU-only representative cannot fill the role.
What is MHRA registration?
Every medical device and IVD placed on the Great Britain market must be registered with the MHRA. For overseas manufacturers, the UKRP makes the registration on your behalf and keeps it up to date.
Is a UKRP needed for Northern Ireland?
No. Northern Ireland follows EU MDR and IVDR, so manufacturers based outside the EU and Northern Ireland need an Authorised Representative established in the EU or Northern Ireland instead.
What are the UKRP's main responsibilities?
Checking that your Declaration of Conformity and technical documentation are in place, keeping copies for the MHRA, registering your devices, responding to MHRA requests, cooperating on corrective actions and forwarding complaints and incident reports to you.
Can I change my UK Responsible Person?
Yes. The new UKRP updates your MHRA registration, and your labelling and documents are updated with the new UKRP details. We manage the handover so there is no gap in representation.
Need a UK Responsible Person?
Send us your device list using the form below and we'll send you a quote for UKRP and MHRA registration.
