CONSULTANCY /

UKRP (UK Authorised Representative)

Compliant UK Market access for Non‑UK medical device manufacturers

Place your medical devices and IVDs on the UK market with confidence, backed by a trusted UK Responsible Person (UKRP).

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Meeting UK requirements Is mandatory. Choosing the right UKRP is critical.

What matters is who you trust with the responsibility.

If you’re based outside the United Kingdom and want to sell medical devices or IVDs in Great Britain, you must appoint a UK Responsible Person (UKRP) under the UK Medical Device Regulations.

But responsibility goes beyond a label on your paperwork.

The official point of contact for UK Authorities & MHRA.
Listed on your product documentation and registration.
Directly involved in post-market activities and compliance enquiries.

The right authorised representative protects you from risk.

Why manufacturers choose us

Professional, accountable, and UK regulator‑ready

Specialist knowledge in UK medical device compliance

Our regulatory team has in‑depth UK MDR knowledge and experience dealing with MHRA expectations, inspections, and compliance reviews.

Clear, timely communication

We provide direct, professional responses and updates — especially when rapid action matters, such as during MHRA enquiries or post‑market reporting.

Your dedicated compliance partner

We provide ongoing support throughout the device lifecycle, with transparency and accessibility built into our processes.

Professional & accountable

All engagements are governed by clear terms, confidentiality, and responsibility agreements — so you know what’s covered and where liability lies.

What we do as your UK Authorised Representative

Focused on safety, compliance, and continuity
Act as your official UK regulatory representative
Serve as the primary liaison with the MHRA
Confirm and maintain access to your technical documentation and Declarations of Conformity
Support device UKCA registration and record keeping
Coordinate vigilance reporting and incident management
if needed, we are available for regulatory authority enquiries and audits
We help ensure your presence in the UK market remains compliant, proactive, and risk‑managed.

Our onboarding process is quick & simple

Clear, structured, and regulator-ready.
1

Initial Consultation

We confirm scope, device classification, and regulatory readiness.
2

Documentation Review

We review required regulatory documents to ensure compliance and accessibility.
3

Mandate Agreement

You appoint CompliantMD as your UK Responsible Person under the required regime.
4

Registration & Labelling

Support for UKCA device records and regulatory reporting procedures is provided.
5

Ongoing Support

We remain accessible for MHRA communications, vigilance reporting, and regulatory updates.
Need us to sign an NDA? Feel free to download our template.

Who this service is for

Medical device and IVD manufacturers outside the UK
Non‑UK companies seeking UKCA market access
Manufacturers needing long‑term regulatory partnership in the UK
Whether you’re launching new products or replacing an existing representative, this service gives you clarity, support, and confidence.

Frequently Asked Questions

Yes, the UKRP is your representative in the UK for dealing with the MHRA

The device must be CE marked to sell into Northern Ireland and you do not need a UKRP in this instance.

No, You will deal directly with the MHRA if there are any issues with your device.

You can, however, ask us to assist you at any time.

Yes. We can support all of your medical devices and IVDs.

The MHRA will use CompliantMD as a point of contact. If the MHRA contacts us, it may be for a variety of reasons.

  • A request to audit the technical file.
  • Market intelligence or questions on your device with potential safety or efficacy concerns.
  • Market intelligence on a similar device highlighting a potential risk.

Yes, we can help you with consultancy on device documentation, training of staff or internal auditing.

Ready to appoint a trusted UK Authorised Representative?

Let's make your UK market access straightforward, compliant, and low-risk.