Is MHRA device registration mandatory for all UK devices?

Yes. Class I, IIa, IIb, and III medical devices (and IVDs) must be registered with the MHRA before being placed on the GB market. Class I general medical devices must be registered within 12 months of first placing on the market.

Can I use a CE-marked device in the UK without UKCA marking?

CE-marked devices could be placed on the GB market under transitional provisions until 30 June 2028. After that date, UKCA marking and MHRA registration are required. Check current transitional guidance on the MHRA website.

Does the UK Responsible Person register devices on my behalf?

The UK Responsible Person (UKRP) is responsible for ensuring registration happens. Many UKRP providers include MHRA device registration in their onboarding scope or offer it as an add-on.

Book UK MHRA Medical Device Registration Support

Book UK MHRA medical device registration support online. Compare vetted specialists for UKCA or CE-marked device registration with the MHRA. Instant pricing.

✓ 3 active providers available right now · GBP 662 – 819

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
Live availability: 3 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 720	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 819	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 662	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

deviceClass (Required)
I|IIa|IIb|III
deviceFamiliesCount (Required)
min 1
complexity (Required)
simple|normal|complex
turnaround (Required)
standard|rush
desiredOutputs (Required)
min 1
buyerNotes (Optional)

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Market

United Kingdom

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Regulation

UK MDR 2002 / UKCA

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Turnaround

5–15 business days

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Pricing

Per device family

Want to read provider profiles and reviews first? Compare all UK medical device compliance providers →

How it works

1

Describe your device and registration scope

Enter your device class, number of device families, and whether you have an existing UKRP appointed.
2

Compare MHRA registration specialists

View per-device fees from providers experienced with the MHRA's registration portal and requirements.
3

Complete MHRA registration

Your specialist submits registration data to the MHRA database and provides confirmation for your QMS records.

UK medical device registration requirements post-Brexit

Since leaving the EU, the UK has maintained its own medical device registration framework under the UK Medical Devices Regulations 2002 (as amended). All medical devices placed on the Great Britain market must be registered with the MHRA — this applies to Class I, Class IIa, Class IIb, and Class III devices, as well as IVDs. Registration must be completed by the UK Responsible Person (UKRP) or under their authority. The MHRA has been implementing transitional provisions for CE-marked devices to continue being sold in GB through to 30 June 2028, but manufacturers selling into GB in the medium term should plan for full UKCA compliance.

UKCA marking vs. CE marking for the UK market

UKCA (UK Conformity Assessed) marking is the UK's post-Brexit equivalent of CE marking. For medical devices, UKCA requires conformity assessment by a UK Approved Body (for higher-risk device classes), equivalent to the EU notified body process. However, the MHRA's transitional provisions have allowed CE-marked devices to continue being placed on the GB market under specified conditions through 30 June 2028. After this date, UKCA marking (or in some cases, an MHRA-approved route) will be required for all new devices and device versions entering the GB market. Northern Ireland continues to follow EU MDR rules under the Windsor Framework.

What the MHRA registration process involves

MHRA device registration requires submitting device information to the MHRA's registration database, including device classification, intended purpose, risk class, applicable standard (CE or UKCA), notified body or UK Approved Body certificate reference, and the UK Responsible Person's details. Class I general medical devices have a self-certification pathway. Class IIa, IIb, and Class III devices require notified body involvement. The MHRA may verify submission data and can request supporting technical documentation. Registration must be maintained and updated when device versions, intended purposes, or UKRP details change.

What happens if your device is not MHRA-registered?

Placing a non-registered medical device on the GB market is an offence under UK law. MHRA enforcement actions include formal warnings, product recalls, import bans, and prosecution. Since 2021, MHRA market surveillance has increased and is specifically targeting devices placed on the GB market without valid registration. Distributors and retailers are also required to verify that devices they handle are MHRA-registered, so an unregistered device will typically be blocked upstream in the supply chain. Ensuring registration is in place before your first GB sale is essential to avoid disruption to your distribution network.

Frequently asked questions

Is MHRA device registration mandatory for all UK devices?: Yes. Class I, IIa, IIb, and III medical devices (and IVDs) must be registered with the MHRA before being placed on the GB market. Class I general medical devices must be registered within 12 months of first placing on the market.
Can I use a CE-marked device in the UK without UKCA marking?: CE-marked devices could be placed on the GB market under transitional provisions until 30 June 2028. After that date, UKCA marking and MHRA registration are required. Check current transitional guidance on the MHRA website.
Does the UK Responsible Person register devices on my behalf?: The UK Responsible Person (UKRP) is responsible for ensuring registration happens. Many UKRP providers include MHRA device registration in their onboarding scope or offer it as an add-on.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

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