UK Responsible Person for Medical Devices

Examples of medical devices and diagnostic equipment covered by our UKRP service

Examples of the medical devices and IVDs we act as UK Responsible Person for — from Class I equipment through to complex diagnostic systems.

Who Needs This

Covers every device class

UK Responsible Person duties apply across the full range of medical devices and in vitro diagnostics, regardless of risk classification.

Class I

General medical devices, incl. Class Is / Im

Class IIa

Medium-risk devices

Class IIb

Medium-to-high-risk devices

Class III

Highest-risk devices

IVD

In vitro diagnostic devices

What We Do

Everything covered by our UKRP service

UKRP registration & appointment

We register as your named UK Responsible Person with the MHRA and act as your legal representative for GB market access.

MHRA device registration

We prepare and submit your device registration to the MHRA, keeping your listing accurate as your range changes.

Technical file review

We check your technical documentation against UK requirements and flag any gaps before they become a problem.

UKCA compliance support

Guidance on UKCA marking requirements and transition planning alongside your existing CE certification.

Clinical evaluation review

We review clinical evaluation reports and evidence for alignment with UK regulatory expectations.

Post-market surveillance

Support with vigilance reporting and post-market surveillance obligations for the GB market.

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What a UK Responsible Person actually does

Under UK MDR 2002, your UK Responsible Person must hold your technical documentation, act as your contact point for the MHRA and UK market surveillance authorities, and be named on your device registration. It's a formal legal role — not just a mailing address — which is why the person or organisation you appoint matters. Full detail is in the MHRA's own guidance: Regulating medical devices in the UK.

FAQ

Medical devices UKRP — common questions

Do I need a UK Responsible Person if I already have a CE mark?

Yes. CE marking (or an EU Authorised Representative) covers the EU market, but a separate UK Responsible Person is required to place devices on the Great Britain market, regardless of your CE status. See gov.uk's guidance on regulating medical devices in the UK, or our guide to UK vs EU Responsible Person for the full picture.

Is CE marking still accepted in Great Britain?

Yes, for now. Devices CE-marked under the old EU MDD/AIMDD are recognised in GB until 30 June 2028, and devices meeting EU MDR or IVDR (or the old IVDD) are recognised until 30 June 2030. UKCA and CE marking can also both be used on the same product. We'll confirm exactly which transitional route applies to your device — see our full UKCA marking guide for more detail.

Does this apply the same way in Northern Ireland?

No — Northern Ireland follows different rules under the Windsor Framework, and CE marking (via the EU regime) generally continues to apply there rather than UKCA. If you sell into both Great Britain and Northern Ireland, tell us and we'll confirm what's needed for each.

Can one UK Responsible Person cover multiple device classes?

Yes — we act as UKRP across your full product range, from Class I through to Class III and IVDs, under a single agreement.

How long does registration take?

Once your technical documentation is in order, MHRA registration typically takes a few weeks. We'll give you a specific timeline after reviewing your file at the free consultation stage.

What happens if my documentation has gaps?

We flag any gaps during the technical file review and advise on what's needed to close them before submission — this is a routine part of onboarding, not a reason for delay in most cases.

UK Responsible Person for medical device manufacturers