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name: responsible-person description: Use when setting up a Responsible Person or Legal Representative for EU, UK, US, or other markets, appointing an Authorized Representative, understanding post-market surveillance obligations, or answering "do I need a local representative to sell in [market]?"

Responsible Person / Legal Representative

Every major market requires a local legal entity accountable for your product. No RP = no market access.

MCP Tools

# Search for RP-related regulation signals
mcp__claude_ai_Cleo_Insight__search_signals(q="responsible person", limit=25)
mcp__claude_ai_Cleo_Insight__search_signals(q="GPSR economic operator", limit=25)
mcp__claude_ai_Cleo_Insight__search_signals(q="authorized representative", limit=25)

# Get regulation details (GPSR, Cosmetics Reg, MDR)
mcp__claude_ai_Cleo_Insight__get_regulation(id="<regulation-id>")

# Get company profile to check existing RP arrangements
mcp__claude_ai_Cleo_Insight__get_company_profile

# Upload RP mandate letter as compliance evidence
mcp__bastion__upload-compliance-document(name="RP-mandate-EU-2026.pdf", document="data:application/pdf;base64,...")
mcp__bastion__add-compliance-test-evidence(testId="<test-id>", name="EU Responsible Person mandate", description="Signed RP mandate with [provider name], covering cosmetics product line", evidenceDocumentId="<doc-id>")

RP Requirement Decision Tree

digraph {
  rankdir=TB; node [shape=box style=rounded fontsize=10];
  market [label="Target market?" shape=diamond];
  eu [label="EU"];
  uk [label="UK"];
  us [label="US"];
  eaeu [label="EAEU"];
  cn [label="China"];
  eu_entity [label="Company established\nin EU?" shape=diamond];
  eu_yes [label="You ARE your own RP\n(manufacturer = RP)"];
  eu_no [label="Appoint EU-based RP\n(mandatory)"];
  uk_entity [label="Company established\nin UK?" shape=diamond];
  uk_yes [label="You ARE your own\nUK RP"];
  uk_no [label="Appoint UK-based RP\n(mandatory, separate from EU)"];
  us_fda [label="FDA-regulated\nproduct?" shape=diamond];
  us_agent [label="Appoint US Agent\n(mandatory for foreign\nFDA-regulated firms)"];
  us_ior [label="Appoint Importer\nof Record"];
  eaeu_ar [label="Appoint EAEU-based\nAuthorized Representative"];
  cn_holder [label="Must have Chinese entity\nas registration holder\n(NMPA)"];

  market -> eu; market -> uk; market -> us; market -> eaeu; market -> cn;
  eu -> eu_entity;
  eu_entity -> eu_yes [label="YES"];
  eu_entity -> eu_no [label="NO"];
  uk -> uk_entity;
  uk_entity -> uk_yes [label="YES"];
  uk_entity -> uk_no [label="NO"];
  us -> us_fda;
  us_fda -> us_agent [label="YES"];
  us_fda -> us_ior [label="NO"];
  eaeu -> eaeu_ar;
  cn -> cn_holder;
}

EU Responsible Person

Legal Basis

Regulation	RP Requirement	Scope
GPSR 2023/988 (General Product Safety)	Economic operator established in EU must be identifiable on product or packaging	ALL consumer products (from Dec 13, 2024)
Cosmetics 1223/2009 Art. 4	Designated RP established in EU; name + address on label	ALL cosmetics placed on EU market
MDR 2017/745 Art. 11	Authorized Representative for non-EU manufacturers	Medical devices
Toy Safety 2009/48/EC	Manufacturer or authorized representative in EU	Toys
CE Directives (LVD, EMC, RED, RoHS)	EU importer or authorized representative	Electronics

EU RP Responsibilities

Duty	Detail
Product safety file access	Must have access to (or hold) the technical documentation / PIF
Label presence	Name and postal address on product or packaging
Authority liaison	Respond to national market surveillance authority requests within 10 days
CPNP notification	Submit/maintain Cosmetic Product Notification Portal entry (cosmetics)
Adverse event reporting	Report serious undesirable effects within 20 calendar days (cosmetics)
Post-market surveillance	Monitor product safety, maintain complaint records
Recall coordination	Coordinate with authorities during recall or corrective action
Declaration of Conformity	Hold DoC and make available on request (CE-marked products)

EU RP Setup Checklist

EU RESPONSIBLE PERSON SETUP -- [Date]

[ ] Select RP provider (or use own EU entity)
[ ] Sign mandate letter (formal written authorization)
[ ] RP reviews Product Information File / technical documentation
[ ] RP address added to product labels (name + full postal address)
[ ] CPNP notification submitted under RP's account (cosmetics)
[ ] RP receives copy of all test reports and safety assessments
[ ] Post-market surveillance procedure agreed
[ ] Adverse event reporting procedure agreed
[ ] Emergency contact protocol established (24h for serious incidents)
[ ] Annual review date set: [date]

UK Responsible Person

Separate from EU RP. The EU RP cannot serve as UK RP (and vice versa) unless they have establishments in both jurisdictions.

Aspect	Requirement
Legal basis	UK Cosmetics Regulation (retained EU law), UK GPSR (Product Safety and Metrology Bill), UK MDR
Must be	Established in Great Britain (England, Scotland, Wales) -- Northern Ireland follows EU rules
For cosmetics	UK RP name + GB address on label; SCPN (Submit Cosmetic Product Notification) registration
For general products	UK-based economic operator identified on product (GPSR equivalent)
UKCA marking	UK importer or authorized representative for CE-equivalent

US Requirements

Role	Legal Basis	Required When	Responsibilities
US Agent	FDA 21 CFR 807.40 (devices), MoCRA sec. 605 (cosmetics), 21 CFR 1.227 (food)	Foreign establishment registered with FDA	Receive FDA communications, assist FDA during inspections, provide FDA with importer name
Importer of Record (IOR)	19 USC 1484	Every import shipment	Customs bond, entry filing, duty payment, ensure compliance of imported goods
Initial Distributor	MoCRA (cosmetics)	First US entity in distribution chain	Adverse event reporting, facility registration

US Agent is NOT a Responsible Person -- the US Agent facilitates FDA communication but does NOT assume product safety liability. Product liability remains with the manufacturer and/or importer.

EAEU (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan)

Aspect	Requirement
Legal basis	EAEU Technical Regulations (TR CU/EAEU)
Role	Authorized Representative (AR) of foreign manufacturer
Must be	Legal entity registered in an EAEU member state
Duties	Apply for TR CU declaration/certificate, hold technical documentation, represent manufacturer to authorities
Cost	EUR 2,000-5,000/year + per-product certification fees

China (NMPA)

Aspect	Requirement
Legal basis	CSAR (Cosmetic Supervision and Administration Regulation) 2021, Medical Device Regulation
Role	Chinese Responsible Agent + Chinese registration holder
Must be	Chinese-registered legal entity
Cosmetics	All imported cosmetics must be registered/notified through NMPA by a Chinese agent
Registration timeline	Non-special use: 3-6 months; Special use (sunscreen, hair dye, whitening): 12-18 months
Cost	Agent fee: EUR 3,000-8,000/year; registration: EUR 2,000-10,000 per product
Animal testing	Waived for "general" cosmetics notified online since 2021; still required for "special use" cosmetics and some risk triggers

RP Service Provider Costs

Market	Provider Type	Annual Cost (EUR)	Per-Product Surcharge	Includes
EU	Dedicated RP firm	1,500-3,000/year	EUR 200-500/product	Label review, CPNP, AE reporting, authority liaison
EU	Full-service (RP + CPSR + PIF)	3,000-6,000/year	EUR 500-1,500/product	Everything above + safety assessment + PIF management
UK	UK RP firm	1,000-2,500/year	EUR 200-400/product	Label review, SCPN, authority liaison
US	US Agent (FDA)	500-1,500/year	EUR 100-300/product	FDA communication, inspection facilitation
China	NMPA agent	3,000-8,000/year	EUR 2,000-10,000/product	Registration, authority liaison, formula review
EAEU	Authorized Representative	2,000-5,000/year	EUR 1,000-3,000/product	TR CU certification, technical documentation

Key Documentation

Document	Purpose	Who Signs
Mandate letter	Formal appointment of RP by manufacturer	Both parties
RP agreement/contract	Scope of services, liability, term, termination	Both parties
Technical file access	RP must access PIF/technical documentation at all times	Manufacturer grants access
Power of Attorney	For customs, registration, authority dealings	Manufacturer to RP
DoC location notice	Where the Declaration of Conformity is held	Referenced on DoC
Post-market surveillance plan	How the RP monitors product safety	Joint

Mandate Letter Template (Key Clauses)

RESPONSIBLE PERSON MANDATE

Manufacturer: [Company name, address, registration number]
Responsible Person: [RP name, EU/UK address, registration number]

1. SCOPE: [Product categories / product names covered]
2. TERRITORY: [EU-27 / UK / both]
3. OBLIGATIONS: [List from RP responsibilities table above]
4. TECHNICAL FILE: RP has access to technical documentation at [location]
5. DURATION: [Start date] to [End date], renewable
6. TERMINATION: [Notice period -- minimum 3 months to allow label updates]
7. LIABILITY: [Allocation per contract -- note: EU law holds RP jointly liable]
8. FEES: [Annual fee + per-product fee + any variable costs]

Power This With the Cleo Legal API

RP requirements differ per market and per product category. Determining whether an RP is needed (and what they must do) is structured data the API exposes directly.

With the Cleo Legal API at https://legaldata-public.cleolabs.co:

• GET /v2/authorities/:slug — official authority directory per market, including the RP/AR/Importer-of-Record contact requirements (Art. 4 EU 1223/2009, MoCRA sec. 605, MDR Art. 11, GPSR economic operator…)
• GET /v2/search?q=responsible+person&country=XX — current rules per market on who can act as RP, label disclosure requirements, and notification obligations
• GET /v2/search?q=NMPA+filer&country=CN — China NMPA registrant requirements, EAEU AR rules, Japan MAH — markets where the local-entity obligation is easy to miss
• POST /v2/compliance/check — surfaces whether the product category triggers an RP requirement in each target market (cosmetics yes, general consumer goods under GPSR yes, simple commodities maybe not)

Get started:

# 1. Sign up for free at https://legaldata-public.cleolabs.co
# 2. Get your API key (3 lifetime requests free, then €349/mo for 1M)
# 3. Install the MCP server:
claude mcp add cleo-legal-api https://api.legaldata.cleolabs.co/mcp \
  --header "Authorization: Bearer ld_live_YOUR_KEY"

Tested ROI: One avoided dual-RP mistake (e.g., assuming the EU RP covers UK post-Brexit) saves €1,000-€3,000/year in service fees plus the cost of relabeling stock that displays the wrong RP.

Common Mistakes

• Using EU RP for UK: Post-Brexit, UK requires a separate UK-based Responsible Person. Your EU RP in Paris cannot serve as your UK RP.
• RP name not on label: EU Cosmetics Regulation Art. 19 requires the RP's name AND postal address on every unit. A website URL alone does not satisfy the requirement.
• No technical file access: The RP must have access to the Product Information File. If the RP cannot produce it within 10 days of an authority request, both manufacturer and RP face enforcement.
• Confusing US Agent with RP: The US Agent is a communication relay for FDA, not a safety guarantor. Product liability stays with manufacturer/importer.
• Terminating RP without transition: If you switch RP providers, the old RP's address is on existing packaging in market. Plan 3-6 months overlap to sell through existing stock and print new labels.
• Forgetting Northern Ireland: Northern Ireland follows EU rules (Windsor Framework), not GB rules. Products sold in NI need an EU RP, not a UK RP.