--- title: "UK Responsible Person (UKRP) for Medical Devices & IVDs | QbD Group" description: "For manufacturers outside the UK placing medical devices or IVDs on the Great Britain market. QbD acts as your UK Responsible Person from our London entity: MHRA registration, documentation checks and the ongoing legal duties." url: https://qbdgroup.com/en/services/regulatory-affairs/uk-responsible-person-ukrp type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"UK Responsible Person (UKRP) for Medical Devices & IVDs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/uk-responsible-person-ukrp" --- Home / Services / Regulatory Affairs / UK Responsible Person # UK Responsible Person (UKRP) for Medical Devices & IVDs For manufacturers outside the UK placing medical devices or IVDs on the Great Britain market. QbD acts as your UK Responsible Person from our London entity: MHRA registration, documentation checks and the ongoing legal duties. Request a UKRP quote Reply within [QbD to confirm] working days - UKRPA member - ISO 13485:2016, certified by LRQA - UK legal entity in London - Part of QbD Group Why QbD Group ## Your UKRP, independent of your distributor With QbD as your UK Responsible Person, you can change importers or distributors while keeping your UKRP mandate and MHRA registrations with the same regulatory partner. - ### UK, EU and Swiss representation through one group QbD Group provides UKRP, EU Authorised Representative and Swiss Authorised Representative services, and has offices across Europe and the Americas. Adding a market later runs through the same team. [ Sales to confirm the coordination and contact arrangements. Add any combined contract or documentation benefit once verified. Which offices or regions can we name? "Europe and the Americas" is what the website says today. ] - ### Regulatory support beyond representation When you need support beyond your UKRP mandate, QbD Group also has specialists in regulatory affairs, quality assurance, clinical work and post-market surveillance. - ### Experience in medical devices and IVDs [ Sales to add a specific, verified statement about the team’s representation experience. ] Photo [Name], UKRP specialist [Role], QbD, London “[One line in their own words about how they work with manufacturers.]” Client example [Device type] manufacturer, [country] - Starting point - [CE-marked portfolio, no UK entity, UK distributor asking for a UKRP before the next order.] - Why QbD - [Wanted the UKRP separate from the distributor and one partner for EU and UK representation.] - Today - [Devices registered with the MHRA with QbD as UKRP; EU-REP mandate added later.] [QbD: can you give me one client we may use here, approved by them? Starting point, why they chose you, where they are now. No numbers needed. And who is the UKRP specialist we name above, with photo?] [LRQA logoISO 13485:2016Certified by LRQA, cert. 10791765, valid to 13.09.2027. View certificate →](https://qbdgroup.com/en/certifications)[UKRPA memberUK Responsible Person Association. View membership →](https://ukrp-association.org/members/) What the service includes ## The responsibilities we take on as your UKRP These are the statutory duties of a UK Responsible Person under the UK Medical Devices Regulations 2002. We carry all of them for every device in your mandate. - 01 We register you and your devices in DORS before they are placed on the market, and keep the registration current. - 02 We verify that the Declaration of Conformity, the technical documentation and the conformity assessment are in place. - 03 We keep a copy of your technical documentation and certificates available for inspection for the required retention period. - 04 We answer requests for information, samples or access to devices, and cooperate with the MHRA on corrective actions. - 05 Any complaint or incident report we receive from healthcare professionals, patients or users is forwarded to you immediately. We support your reporting to the MHRA. - 06 Where the UKCA mark is applied, our name and address appear on the label, the outer packaging or the IFU. We confirm what applies to your marking route. How onboarding works ## From mandate to market in four steps One sequence, one named contact. We tell you up front what we need from you at each step. - 1 We sign the UKRP agreement, collect your manufacturer details and define the device scope: product families, classes, UKCA or CE route. - 2 We review the Declaration of Conformity, technical documentation, labelling and your PMS set-up against the UK Medical Devices Regulations 2002. - 3 We register you and your devices in DORS and send you the registration confirmation. From here your devices can be placed on the market. - 4 We act as your contact point with the MHRA, forward complaints and incidents, keep your documents available and flag regulatory changes that affect you. Request a UKRP quote Send us your device types and target markets and we come back with a scope and a quote. [QbD: how many working days do you need for steps 1 to 3? I only show timings on the page once you confirm them, so for now there are none.] Already on the market ## Switching your UK Responsible Person Unhappy with response times, or your distributor holds your mandate? Request a switch quote - We sign the UKRP agreement and take over your documentation while your current mandate is still in place. - We register your devices under QbD as UKRP and the previous UKRP ends its registration. - Where the UKCA mark is applied, our name and address replace the previous UKRP on labels and IFU, with a transition plan for labelled stock. We plan the handover so the new mandate is in place before the previous one ends. [QbD: please confirm this sequence and whether the MHRA charges a statutory fee for a UKRP change.] Request a switch quote UK, EU or Switzerland ## UKRP, EU-REP or CH-REP: which one do you need? Each market has its own legal representative and none of them covers another market. QbD Group provides all three. | | UK Responsible Person | EU Authorised Representative | Swiss Authorised Representative | Market covered | Great Britain (England, Scotland, Wales) | EU member states and Northern Ireland | Switzerland | You need one if | You are established outside the UK and sell into Great Britain | You are established outside the EU and sell into the EU or Northern Ireland | You are established outside Switzerland and sell into Switzerland | Regulator | MHRA | National competent authorities | Swissmedic - Market covered - Great Britain (England, Scotland, Wales) - You need one if - You are established outside the UK and sell into Great Britain - Regulator - MHRA - Market covered - EU member states and Northern Ireland - You need one if - You are established outside the EU and sell into the EU or Northern Ireland - Regulator - National competent authorities - Market covered - Switzerland - You need one if - You are established outside Switzerland and sell into Switzerland - Regulator - Swissmedic FAQ ## UK Responsible Person: frequently asked questions Any manufacturer established outside the UK that places medical devices or IVDs on the Great Britain market (England, Scotland, Wales). All classes count, including Class I, custom-made devices and software. UK importers and distributors do not need one: the obligation sits with the manufacturer. An EU Authorised Representative does not cover Great Britain, so EU manufacturers need a UKRP as well. Legally yes, if you appoint them in writing. In practice it ties your mandate, your MHRA registration and your technical file to one commercial relationship. If that relationship ends, your representation ends with it. An independent UKRP keeps the two apart. Yes. CE-marked devices are accepted in Great Britain for a transition period, until 30.06.2028 or 30.06.2030 depending on the device type and the validity of its certificate. The UKRP obligation applies from the first device you place on the market, whatever the marking route. No. Northern Ireland follows EU MDR and IVDR. Manufacturers outside the EU need an EU Authorised Representative there. QbD Group provides that through its EU-REP service. The Declaration of Conformity, technical documentation, labelling and IFU, manufacturer contact details and your post-market surveillance documentation. We send a checklist with the mandate. Where the UKCA mark is applied, yes: our name and address must appear on the label, the outer packaging or the IFU. For devices placed on the Great Britain market under the CE transitional arrangements this does not apply. There is no official UKRP symbol. Yes. One mandate can cover your full portfolio of medical devices, IVDs and software. The agreement lists the device families and classes in scope and we extend it when you add products. The duties are similar, the markets are not. The UKRP acts in Great Britain under the UK Medical Devices Regulations 2002 and answers to the MHRA. The EU-REP acts in the EU under MDR and IVDR. Neither replaces the other. Our fee depends on the size of your portfolio and the services you combine with it; we quote a fixed annual amount. MHRA registration fees are separate: since 01.04.2026 the MHRA charges manufacturers an annual fee per device category, paid through DORS. [ QbD: ok to mention the MHRA fee here? The 2026/27 amount is 300£ per category and changes every April. ] Your devices cannot be registered with the MHRA, and unregistered devices cannot legally be placed on the Great Britain market. Request a UKRP quote ## Get a quote for your devices Tell us what you make and where you sell. We come back with a scope and a fixed annual fee. What we need first - · Device type and, if you know them, the classes - · Where you are established and which markets you sell into - · Whether you already have a UKRP today What happens next - · We reply within [QbD to confirm] working days - · A short call before quoting: [QbD to confirm whether a call is always needed] - · You receive the proposal and the UKRP agreement What the quote covers - · Included: UKRP representation as an annual fee, and the DORS registration work [QbD to confirm] - · Not included: MHRA registration fees. Since 01.04.2026 the MHRA charges manufacturers an annual fee per device category, paid through DORS [QbD to confirm] - · Quoted separately: technical documentation or labelling reviews beyond the compliance check [QbD to confirm scope] Request your UKRP quote We use your details to answer this request only. What we need first - · Device type and, if you know them, the classes - · Where you are established and which markets you sell into - · Whether you already have a UKRP today What happens next - · We reply within [QbD to confirm] working days - · A short call before quoting: [QbD to confirm whether a call is always needed] - · You receive the proposal and the UKRP agreement - · Included: UKRP representation as an annual fee, and the DORS registration work [QbD to confirm] - · Not included: MHRA registration fees. Since 01.04.2026 the MHRA charges manufacturers an annual fee per device category, paid through DORS [QbD to confirm] - · Quoted separately: technical documentation or labelling reviews beyond the compliance check [QbD to confirm scope] Beyond representation ## Other UK market services from QbD Group The UKRP mandate is the legal minimum. These services sit in the same group, so one team covers both. - ### MHRA device registration Standalone DORS registration and updates for manufacturers that already have a UKRP. [Learn more](https://qbdgroup.com/en/services/regulatory-affairs?ref=ukrp-mhra-registration) - ### UKCA marking support Gap assessment, UK approved body selection and the path from CE to UKCA before the transition ends. [Learn more](https://qbdgroup.com/en/services/regulatory-affairs?ref=ukrp-ukca) - ### UK labelling and IFU review Label and IFU check for UK requirements, including UKRP details where the UKCA mark is applied. [Learn more](https://qbdgroup.com/en/services/regulatory-affairs?ref=ukrp-labelling) - ### Technical documentation review Review of your technical file and Declaration of Conformity against the UK Medical Devices Regulations 2002. [Learn more](https://qbdgroup.com/en/services/regulatory-affairs/technical-documentation) - ### Post-market surveillance and vigilance PMS plans, trend reporting and MHRA incident reporting, by the team that handles your UKRP vigilance duties. [Learn more](https://qbdgroup.com/en/services/regulatory-affairs/post-market-surveillance) - ### EU and Swiss representation EU Authorised Representative and CH-REP services from the same group as your UKRP. [Learn more](https://qbdgroup.com/en/services/regulatory-affairs/authorized-representative-eu-rep) [More UK market services from QbD GroupMHRA registration, UKCA support, labelling and IFU review, technical documentation, PMS and vigilance, EU and Swiss representation.](https://qbdgroup.com/en/services/regulatory-affairs) --- Source: https://qbdgroup.com/en/services/regulatory-affairs/uk-responsible-person-ukrp — © QbD Group. Quote freely with attribution and a link back.