Why Correct MHRA Registration Matters
Legal background
To lawfully sell, lease, lend, or donate medical devices in Great Britain, manufacturers must complete MHRA registration through their appointed UK Responsible Person (UK RP). Working with an experienced UK RP, such as Obelis UK Ltd., ensures compliance with MHRA requirements, reduces regulatory risks, and supports a faster route to market.
The risks of incorrect MHRA registration
What's at stake without proper MHRA registration
Regulatory enforcement
Products may be subject to regulatory action, including product withdrawal.
Delayed market access
Registration issues can postpone entry to the Great Britain market and delay commercial opportunities.
Supply restrictions
Non-compliant products may face legal barriers when supplied to distributors or end users.
Reputational damage
Regulatory non-compliance can reduce customer confidence and harm your company's reputation.
Our services
The Process of Registering Medical Devices with the MHRA
Understanding how to register a medical device promptly is key to meeting UK regulatory obligations. Acting as your appointed UK Responsible Person, Obelis will handle MHRA registration for your medical devices no matter their classification. We support:
- Class I, IIa, IIb, III medical devices
- Custom-made devices
- IVDs and performance evaluation devices
- Systems and procedure packs
- Preparing and submitting your technical documentation
We verify compliance with UK MDR 2002, oversee your technical documentation, and keep your MHRA registrations current.
From registering multiple device classes at once to advising on CE versus UKCA marking strategy, Obelis UK manages the complexity for you. We also confirm your labelling meets UK regulatory standards, including the correct display of the UK Responsible Person’s name and address.
1
Step 1
Assess Your Device
We identify the applicable MHRA registration requirements based on your medical device, IVD, or custom-made device.
2
Step 2
Review Your Documentation
We verify your technical documentation and labelling to ensure compliance with UK MDR 2002.
3
Step 3
Register with the MHRA
As your UK Responsible Person, we complete and manage your MHRA device registration.
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Step 4
Keep Your Registration Up to Date
We maintain your MHRA registration, monitor regulatory changes, and provide ongoing UK compliance support.
Related Services
Compliance for Medical Devices in the United Kingdom
Frequently Asked Questions
Under the UK Medical Devices Regulations 2002 (UK MDR 2002), medical devices, IVDs, custom-made devices, refurbished or re-labelled devices, and systems and procedure packs must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before they can be placed on the Great Britain market (England, Scotland, and Wales). This requirement applies regardless of the device classification.
For manufacturers established outside the UK, MHRA registration must be completed through an appointed UK Responsible Person (UK RP). The UK RP submits the required registration information, maintains regulatory records, and acts as the official point of contact between the manufacturer and the MHRA, helping ensure ongoing compliance with UK MDR 2002.
To complete MHRA registration, manufacturers must provide accurate device information and ensure their technical documentation complies with UK MDR 2002. Depending on the product, registration may also require compliant labelling, including the UK Responsible Person’s name and address, as well as supporting documentation demonstrating regulatory compliance.
Medical devices that are not properly registered with the MHRA cannot be lawfully placed on the Great Britain market. Failure to comply may result in regulatory enforcement, product withdrawal, delayed market access, restrictions on supplying distributors or end users, and damage to a manufacturer’s reputation.