UK Responsible Person: when you need one
10 min read
British law requires a UK Responsible Person only for cosmetics and medical devices. Who you need for other products in Great Britain and Northern Ireland.
You make products outside Europe, for example in the U.S. or Canada, and plan to sell in Great Britain. Offers and supplier questionnaires keep telling you that you need a UK Responsible Person. British law uses that role for only two product groups: cosmetics and medical devices. For other products, the local roles are the UK importer and, under some rules, a UK authorized representative, while Northern Ireland follows EU rules. Here is which role you need and whose details go on the label.
What a UK Responsible Person is under British law
The term is not a general concept of British product law. It appears in two sets of rules for Great Britain (England, Scotland and Wales):
- Cosmetics: no cosmetic product may be placed on the market without a responsible person established in the UK (Article 4(1) of the UK Cosmetics Regulation (opens in a new tab)). This is Regulation (EC) No 1223/2009 as amended for Great Britain, mainly by Schedule 34 of statutory instrument (SI) 2019/696.
- Medical devices: a manufacturer based outside the UK appoints a sole UK Responsible Person (regulation 7A(2)(a)(ii) of the UK Medical Devices Regulations 2002 (opens in a new tab), UK MDR 2002).
For all other products, British law speaks of producer, importer and authorized representative.
UK Responsible Person compared: EU, Great Britain, Northern Ireland
MHRA is the UK’s Medicines and Healthcare products Regulatory Agency; GPSR the EU General Product Safety Regulation (EU) 2023/988.
| Product group | EU | Great Britain | Northern Ireland |
|---|---|---|---|
| Cosmetics | Responsible Person in the EU (Art. 4 Regulation (EC) No 1223/2009) | UK Responsible Person; notification before launch (Art. 4, 13) | Responsible Person in Northern Ireland or the EU |
| Medical devices (maker outside the UK and EU) | Sole authorized representative in the EU (Art. 11 Regulation (EU) 2017/745) | Sole UK Responsible Person; MHRA registration (reg. 7A) | EU rules: authorized representative in the EU or Northern Ireland |
| Other consumer products | Economic operator in the EU (Art. 16(1) GPSR) | Producer: UK representative, else UK importer (reg. 2 General Product Safety Regulations 2005) | GPSR: operator in Northern Ireland or the EU |
| CE or UKCA products | Economic operator in the EU (Art. 4 Regulation (EU) 2019/1020) | UK importer; representative optional under e.g. reg. 14 Electrical Equipment (Safety) Regulations 2016 | EU rules: operator in Northern Ireland or the EU (Blue Guide 2.9.6) |
Cosmetics: who is the UK Responsible Person
The UK Cosmetics Regulation assigns the role along the supply chain: the UK manufacturer for products made in the UK; for imported products, the UK importer by default; a distributor that sells under its own brand or modifies the product in a way that may affect compliance. The importer or a UK manufacturer can designate another person established in the UK by written mandate, who becomes Responsible Person once it accepts in writing (Article 4(2) to (8)).
The Office for Product Safety and Standards (OPSS), the British product safety regulator, does not accept a mail forwarding or PO box address (OPSS guidance (opens in a new tab)). The Responsible Person’s duties:
- Compliance with the main requirements of the Regulation (Article 5(1)).
- Product information file in English, kept for 10 years after the last batch at the notified address (Article 11).
- Notification before launch through SCPN, the government’s Submit cosmetic product notifications service (Article 13(1); OPSS guidance (opens in a new tab)).
- Label with its name and address and, for imports, the country of origin (Article 19(1)(a)).
Medical devices: the UK Responsible Person under the UK MDR 2002
The MHRA registers devices only from UK-based manufacturers, and every device needs registration before it is placed on the Great Britain market. A manufacturer outside the UK therefore appoints one UK Responsible Person for all its devices, which proves its authority in writing and registers them (MHRA guidance (opens in a new tab); regulation 7A(2)).
Under regulation 7A(3), it checks that the declaration of conformity and technical documentation exist, keeps copies for the MHRA, cooperates on corrective action and ends the mandate if the manufacturer breaches its obligations.
According to the MHRA, its name and address go on the labeling where a UKCA marking is affixed, not on CE-only devices. CE-marked devices are accepted in Great Britain until 30 June 2028 or 30 June 2030 at the latest, depending on the EU rules they meet. An MHRA consultation on recognizing them indefinitely had no published outcome on 6 October 2026.
Other products in Great Britain: importer instead of Responsible Person
For consumer products without sector rules, the General Product Safety Regulations 2005 (opens in a new tab) place the duties, including notifying unsafe products, on the producer: a manufacturer established in the UK, otherwise its UK representative, otherwise the UK-established person placing the product from abroad on the market (regulation 2). Where reasonable, the producer’s name and address and the product reference go on the product or its packaging (regulation 7(4)(a)). Where that is not yet reasonable, OPSS lets importers use documents accompanying the batch until 31 December 2027 (OPSS guidance for Great Britain (opens in a new tab), section 6).
For CE or UKCA products, Great Britain keeps recognizing the CE marking without an end date for many product rules, such as electrical equipment, toys and machinery (SI 2024/696 (opens in a new tab), in force since 1 October 2024). The roles come from each sector regulation, for example the Electrical Equipment (Safety) Regulations 2016 (opens in a new tab):
- UK importer: established in the UK, it puts its name and a postal address on the product (regulation 18(1)). Packaging or an accompanying document is allowed only where that is impossible or, until 31 December 2027, for goods from a European Economic Area (EEA) state or Switzerland (regulation 18(3)); the second option does not cover direct imports from the U.S. or Asia.
- UK authorized representative: optional; appointed by written mandate, at least for keeping the declaration of conformity and technical documentation and cooperating with authorities. You remain responsible (regulation 14).
Other sector rules may make the representative mandatory; gov.uk calls it “essential or voluntary depending on the regulation” (gov.uk guidance (opens in a new tab)).
UK reform: a local responsible person proposed for some products
The Product Regulation and Metrology Act 2025 (opens in a new tab) allows the government to make product regulations, including on appointing authorized representatives (section 2(2)(l)). From 31 March to 23 June 2026, OPSS and the Department for Business and Trade consulted on a new product safety framework (opens in a new tab) to upgrade the regime built on the 2005 Regulations.
Proposal A9 considers a UK-based responsible person (manufacturer, authorized representative or importer) only for some high-risk products. In distance sales without a UK manufacturer, representative or importer, such as parcels shipped straight to consumers, the overseas seller would become the producer. On 6 October 2026, no government response had been published. Proposals are not law; the rules above apply.
Northern Ireland: EU rules, not British ones
In Northern Ireland, EU product law continues to apply under the Windsor Framework. Operators that EU rules require in the Union may be established in Northern Ireland, and goods shipped from Great Britain count as imported (the Commission’s Blue Guide 2022, section 2.9.6). A cosmetics Responsible Person must sit in Northern Ireland or the EU (OPSS); for medical devices, the EU Medical Devices Regulation applies there (MHRA). Consumer products are covered in GPSR in Northern Ireland, not in Great Britain.
What to check, step by step
- Classify each product: cosmetic, medical device, CE or UKCA product, or other.
- Map each channel: who places the product on the market in Great Britain? A UK distributor buying from you is usually the importer.
- Cosmetics: confirm the UK Responsible Person in writing, notify through SCPN before launch and change the labels before 1 January 2028.
- Medical devices: appoint one UK Responsible Person and have it register your devices with the MHRA.
- Other products: agree with your importer whose details go on each unit, and check whether a representative is required.
- Northern Ireland: use your operator in the EU or Northern Ireland.
Practical example: a Canadian beauty brand with three products
A Canadian brand sells a face cream, a hair dryer and a cosmetics bag in Great Britain through a distributor in Manchester:
| Product | Rules in Great Britain | Role of the distributor | On the product |
|---|---|---|---|
| Face cream | UK Cosmetics Regulation | UK Responsible Person as importer, unless it designates another UK person | Responsible Person; EU details only until 31 December 2027 |
| Hair dryer | Electrical Equipment (Safety) Regulations 2016; CE or UKCA | UK importer; representative optional | Manufacturer and importer, each with a postal address |
| Cosmetics bag | General Product Safety Regulations 2005 | Producer as UK importer | Producer’s name, address and product reference, where reasonable |
We recommend agreeing the label text with the distributor before the first UK print run.
Common mistakes with the UK Responsible Person
- Requiring one for every product. The role exists for cosmetics and medical devices only.
- Relying on the EU Responsible Person for cosmetics. It must be established in the UK; EU details on the label work only until 31 December 2027.
- Putting importer details only on the packaging of electrical equipment imported directly from the U.S. or Asia.
- Covering Northern Ireland through a company in Great Britain. Goods from Great Britain count as imported there.
- Confusing it with the UK GDPR representative under Article 27 UK GDPR, a separate data protection role.
Conclusion: check the product group first, then the role
Cosmetics and medical devices need a UK Responsible Person by law; for other products, the UK importer or producer carries the local duties and is named on the product. Northern Ireland runs on EU rules. Our EU and UK market entry checklist puts all three markets into one plan.
Representa acts within the agreed scope and mandate as your EU Authorized Representative or GPSR Responsible Person in the EU; you remain the manufacturer. We also cover the United Kingdom as part of Representation, and UKCA marking support belongs to Compliance. The sections on cosmetics and medical devices are for information.
Frequently asked questions
Do I need a UK Responsible Person?
Only for cosmetics and for medical devices from manufacturers outside the UK. The UK Cosmetics Regulation requires a responsible person established in the UK (Article 4(1)), and the UK Medical Devices Regulations 2002 require a sole UK Responsible Person (regulation 7A). For other products, the British roles are the UK importer or producer.
Can my EU Responsible Person also act for cosmetics in Great Britain?
Not on its own. The Responsible Person must be established in the UK (Article 4(1) UK Cosmetics Regulation). Until 31 December 2027, a label showing the EU Responsible Person as the EU Regulation requires still meets the British label rule (Article 19(1)(ab)); from 1 January 2028, the label must name the UK Responsible Person.
Can my UK importer be the UK Responsible Person?
For cosmetics, the importer is the Responsible Person by default unless it designates another UK person in writing (Article 4(5) to (7) UK Cosmetics Regulation). For medical devices, the MHRA states that an importer or distributor may also act as UK Responsible Person if the manufacturer appoints it.
Does CE-marked electrical equipment need a UK Responsible Person?
Not under that name. Under the Electrical Equipment (Safety) Regulations 2016, the UK importer puts its name and postal address on the product (regulation 18), and a UK authorized representative is optional (regulation 14). Great Britain keeps recognizing the CE marking for this equipment (SI 2024/696).
Will the UK require a Responsible Person for all products?
Not according to current proposals. The 2026 consultation on a new product safety framework considered a UK-based responsible person only for some high-risk products (proposal A9). On 6 October 2026, no government response had been published, so the General Product Safety Regulations 2005 still apply.
