UK vs EU Responsible Person: what's the difference?
Since Brexit, the UK and EU each run their own, entirely separate Responsible Person requirements. Here's what each role actually covers, and why manufacturers selling into both markets usually need two representatives, not one.
Two markets, two separate legal regimes
Before Brexit, a single EU Authorised Representative could cover both the UK and EU markets, because the UK simply applied EU product law directly. That stopped being true once Great Britain left the EU's single market for goods. Great Britain and the EU (which, for most product rules, includes Northern Ireland under the Windsor Framework) now run their own independent frameworks, each requiring its own in-market representative for certain product categories.
The result is that a non-UK, non-EU manufacturer selling into both markets typically needs two separate appointments: a UK Responsible Person established in the UK, and an EU Authorised Representative or Responsible Person established in the EU. One does not substitute for the other, and — critically — the same company usually cannot legally hold both roles, because each role requires establishment inside the market it covers.
What the UK Responsible Person role covers
In UK law, a "Responsible Person" (sometimes "UK Responsible Person" or "UKRP") is a formal role required for two of our core service areas:
- Medical devices and IVDs, under UK MDR 2002 — the UK Responsible Person registers the device with the MHRA, holds technical documentation, and acts as the manufacturer's UK point of contact.
- Cosmetics, under the UK Cosmetics Regulation — the Responsible Person submits the SCPN notification, holds the Cosmetic Product Safety Report and Product Information File, and takes on cosmetovigilance duties.
Outside these two categories, UK law generally does not impose a formal "Responsible Person" title. Food supplements have their own separate compliance route (Food Business Operator registration, not a Responsible Person role — see our food supplements page), and general consumer products sit under the UK's own product safety framework rather than a named representative scheme.
What the EU equivalent covers
The EU runs parallel — but legally distinct — requirements, generally under different names depending on the product type:
- Medical devices and IVDs — an EU Authorised Representative, required under EU MDR/IVDR for manufacturers based outside the EU/EEA.
- Cosmetics — an EU Responsible Person, required under the EU Cosmetics Regulation, functionally similar to its UK counterpart but a completely separate legal appointment.
- General consumer products — since December 2024, the EU General Product Safety Regulation (GPSR) requires an EU-established "responsible economic operator" for most non-food consumer products sold to EU customers, including via online marketplaces. We cover this on our EU GPSR page.
Side-by-side comparison
| Product type | UK role | EU role | Same company can hold both? |
|---|---|---|---|
| Medical devices & IVDs | UK Responsible Person (UK MDR 2002) | EU Authorised Representative (EU MDR/IVDR) | No |
| Cosmetics | UK Responsible Person (UK Cosmetics Regulation) | EU Responsible Person (EU Cosmetics Regulation) | No |
| Food supplements | Food Business Operator registration (no formal RP role) | Varies by EU member state's food law | Not comparable roles |
| General consumer products | No formal RP role currently (subject to a pending 2026 consultation) | Responsible economic operator (EU GPSR) | N/A in UK |
The reason the "same company can hold both" answer is almost always no is structural, not a matter of choice: both regimes require the representative to be established — meaning it has a genuine registered presence — inside the market it's representing. A UK company can't be "established" in the EU by simply opening a mailbox there, and the reverse is equally true.
Why this catches manufacturers out
The most common mistake we see is a manufacturer assuming that appointing one representative — often wherever they found a service first — covers both markets, because that's how it worked before Brexit. It doesn't. A few consequences of getting this wrong:
Marketplaces check this independently
Amazon and other UK/EU marketplaces increasingly ask sellers to name both a UK Responsible Person (for relevant device/cosmetic categories) and an EU GPSR responsible person, and will suspend listings that can't show a valid appointment for the market the listing targets.
- Products can be refused entry, or removed from sale, in whichever market lacks a valid, established representative.
- Technical documentation held only with an EU representative isn't automatically accessible to UK market surveillance authorities (the MHRA, Trading Standards, or the Office for Product Safety and Standards), and vice versa.
- Notifications — SCPN for cosmetics, MHRA device registration — are separate systems that don't share data between the UK and EU, so each needs its own submission through the correct in-market representative.
How we can help
We act as UK Responsible Person for medical device and cosmetics manufacturers directly, handling MHRA registration, SCPN notification, technical file review and ongoing compliance duties. As a UK-based company, we can't legally hold the EU-side role ourselves — but we regularly help clients understand what the EU role requires, review documentation against both frameworks, and connect them with a trusted EU-established partner so nothing falls through the gap between the two systems.