The short answer
A UK Responsible Person is a legal requirement for manufacturers based outside the UK who place medical devices, in vitro diagnostic devices, or cosmetics on the Great Britain market. If your product falls outside those two categories, you likely don't need a "Responsible Person" in the formal legal sense — but you may still have other UK compliance obligations, which we cover below.
Medical devices & IVDs — yes, if you're a non-UK manufacturer
Under UK MDR 2002, any manufacturer based outside the UK must appoint a UK Responsible Person before placing a medical device or in vitro diagnostic device on the Great Britain market, across every device class:
Low risk
Low-medium risk
Medium-high risk
High risk
In vitro diagnostics
The UK Responsible Person registers your device with the MHRA, holds your technical documentation, and acts as your named UK point of contact. See our medical devices UKRP page for the full detail on what the role involves.
Cosmetics — yes, if you're a non-UK manufacturer
The UK Cosmetics Regulation requires a UK-established Responsible Person for cosmetic products placed on the Great Britain market by a manufacturer based outside the UK. This covers the full range of cosmetic product types — skincare, haircare, makeup, fragrance and personal care products — and the Responsible Person handles SCPN notification, the Cosmetic Product Safety Report, the Product Information File, and cosmetovigilance. Full detail on our cosmetics UKRP page.
Food supplements — no formal Responsible Person scheme
This is the case that trips people up most often, because it looks like it should follow the same pattern as medical devices and cosmetics — it doesn't. The UK has no formal "Responsible Person" role for food supplements. Instead, the relevant obligations are:
- Registering as a Food Business Operator (FBO) with your local authority, generally at least 28 days before you start trading
- Ensuring every ingredient is permitted for use, including checking against the Novel Foods Regulation if an ingredient wasn't in significant use before 1997
- Making sure labelling and claims comply with UK food law, and don't stray into medicinal claims that would reclassify the product
We support all of this under import and compliance guidance rather than a Responsible Person appointment — see our food supplements page for the full breakdown.
General consumer products — a different framework entirely
Products without their own dedicated safety regime — homeware, general electronics accessories, and similar — fall under the UK's general product safety framework, currently the General Product Safety Regulations 2005. This framework does not currently impose a formal, named "Responsible Person" role the way the medical device and cosmetics regimes do. A government consultation published in March 2026 has proposed a broader reform of this framework; we're tracking it and will update our guidance once a formal response is published.
If your general product is instead being sold into the EU, a different rule applies: the EU General Product Safety Regulation (GPSR) requires an EU-established responsible economic operator for most categories. See our EU GPSR page — note that as a UK company we can advise and refer on this, but can't hold that EU-side role ourselves.
Quick reference table
| Product type | UK Responsible Person required? | What's actually required instead (if not) |
|---|---|---|
| Medical devices & IVDs | Yes | — |
| Cosmetics | Yes | — |
| Food supplements | No | Food Business Operator registration |
| General consumer products (GB market) | No formal role currently | Compliance with GPSR 2005 (under review) |
| General consumer products (EU market) | Not a "UK" requirement | EU GPSR responsible economic operator |
Still not sure which bucket you fall into?
Borderline cases are common — a product marketed with a health claim can tip from "cosmetic" into "medicinal," and device classification isn't always obvious from the product description alone. If you're not confident which category your product falls into, that's exactly what our free consultation is for: tell us about your product and we'll confirm the correct classification and next steps before you commit to anything.