GPSR Responsible Person / Economic Operator (EU & Northern Ireland)

Compare GPSR Responsible Person / Responsible Economic Operator providers for EU & Northern Ireland. Find GPSR representative services, product safety compliance support, and request quotes.

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RFQs this month
95%
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Compare Best GPSR Responsible Person (EU/NI) | Compare & Get Quotes Providers

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International Associates Limited Verified

International Associates provides expert regulatory compliance services, acting as Authorized Representatives and Responsible Persons for manufacturers worldwide.

International Associates Limited is a UK-based firm offering specialized regulatory compliance services to manufacturers seeking to place their products on the EU and UK markets. They act as appointed Authorized Representatives and Responsible Persons, ensuring adherence to directives and regulations such as the EU Cosmetics Regulation (EC) No 1223/2009 and the UK Cosmetic Products Enforcement Regulations 2013. With expertise in various product categories including cosmetics, toys, medical devices, and general product safety (GPSR), International Associates helps international manufacturers navigate complex legal landscapes. Their services are crucial for companies based outside the EU or UK, providing a local point of contact and ensuring all mandatory tasks and documentation requirements are met. They offer a cost-effective route to certification and compliance, backed by a mission to empower global communities through exceptional services in supply chain management, ESG, regulatory compliance, quality management, and sustainable business solutions. Their commitment to ethical standards and innovative practices drives growth and delivers value to clients and stakeholders worldwide.
Website: ia-uk.com
HQ: Glasgow, United Kingdom
Jurisdictions: EU, UK, CH
Languages: English
Pricing model: Per project
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QLE

At QLE Group, we're all about making the complex world of medical device regulations simple for you. Our team is here to guide MedTech companies through the maze of CE Marking, Quality Management Systems (QMS), FDA submissions, and thorough audits. We're dedicated to ensuring your products don't just meet, but exceed global standards. Services CE Marking: Smooth pathways to get your products into the European market. QMS Implementation: Strong systems that meet ISO 13485 and 21 CFR 820 standards. FDA Submissions: Smart strategies for different types of FDA approvals. Audits: Benefit from our exacting assessments tailored to scrutinize and improve your internal and supplier practices. Our Approach We believe in a personalized touch, ensuring each client gets exactly what they need with smart planning and deep industry knowledge. Our team's expertise in regulations and the MedTech sector means we deliver solutions that push healthcare forward. Why Choose Us Expert Guidance: Our consultants are seasoned pros with a history of success. Customized Solutions: We tailor our services to fit your specific needs. Strategic Partnerships: Work with us for a smooth journey from idea to market. Join our community to keep up with the latest in regulatory news and see how we can boost your MedTech business.

Website: qle.be
Jurisdictions: EU
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ELS Group Verified

ELS Group is a company with deep technical expertise and market access in Regulatory Affairs and Quality Assurance, duly certified. With 18 years of experience, we provide strategic solutions.

HQ: Estoril, Portugal
Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Response SLA: 24 hours
Pricing model: Custom pricing
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Obelis Group

Obelis Group is your trusted partner for global regulatory compliance, specializing in market access for cosmetics, medical devices, and other industries across the EU, UK, US, Canada, and Switzerland.

Obelis Group offers comprehensive regulatory compliance services to facilitate swift and safe market entry for your products worldwide. Specializing in Medical Devices, Cosmetics, and other industries, they provide expert guidance as an Authorized Representative and Responsible Person. Their services span regulations in the EU, UK, US, Switzerland, and Canada, ensuring your products meet diverse international requirements. For the cosmetics industry, Obelis Group provides tailored solutions including Responsible Person services, PIF review, CPNP notifications, label reviews, and product safety reports for markets like the EU, UK, US, and Canada. They also offer US Agent services and FDA facility/FEI registration to navigate the complexities of the US market under MoCRA. With deep experience in EU, UK, and Swiss compliance frameworks, Obelis Group is well-equipped to support your product's journey to market. They act as your official contact with regulatory authorities, manage documentation, and ensure post-market obligations are met, protecting your brand and consumer trust.
Website: obelis.net
HQ: Brussels, Belgium
Jurisdictions: EU, UK
Languages: English, French, Dutch, German
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MDSS (EC REP)

MDSS is a leading European Authorized Representative (EC REP) with over 30 years of experience, specializing in regulatory affairs for medical and in-vitro diagnostic devices. They offer comprehensive in-country representation services across the EU, UK, Switzerland, USA, and Australia.

MDSS GmbH, established in the European Union, is a trusted Authorized Representative (EC REP) with over 30 years of experience in providing In-Country Representation and specializing in Regulatory Affairs for Medical and In Vitro Diagnostic Devices. They are recognized as a leading European Authorized Representative, serving clients for over two decades from the same trusted address. MDSS offers comprehensive In-Country Representation services across the EU, United Kingdom, Switzerland, USA, and Australia. They act as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, and U.S. Agent, allowing non-EU based companies to focus on their core business, including innovation, while ensuring compliance with regional regulations. Specifically for the EU market, MDSS assists with EU Registration with the European Authorities. They are crucial for non-EU based Medical Devices Companies needing to appoint an EU Authorized Representative to place devices on the EU market, as mandated by regulations like MDR (EU) 2017/745 and IVDR (EU) 2017/746. MDSS also provides representation for compliance with the AI ACT and the General Product Safety Regulation (GPSR). Furthermore, MDSS acts as an EU Representative for the General Data Protection Regulation (GDPR) for processors and controllers operating outside the EU who handle personal data of individuals within the EU. They ensure compliance with Article 27 of the GDPR, acting as a point of contact for supervisory authorities and data subjects.
Website: mdss.com
HQ: Schleswig-Holstein, Germany
Jurisdictions: EU
Languages: English, German
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Euverify Verified

Euverify provides automated compliance tools and GDPR Representative services to help businesses meet EU/UKCA regulations. Streamline your compliance journey with expert guidance.

Euverify offers a comprehensive platform designed to simplify your compliance journey. Their services include automated compliance tools for EU/UKCA regulations, helping you generate necessary declarations and understand complex requirements. They also provide a GDPR Representative Module, assisting businesses in meeting their obligations under GDPR. The Euverify Help Center offers step-by-step guides, feature explanations, and answers to common compliance questions, ensuring you can efficiently manage your account, appoint authorized representatives, and keep your products legally compliant. Whether you are new to compliance or switching systems, Euverify aims to make the process seamless and efficient.
Website: euverify.com
HQ: London, GB
Jurisdictions: EU, UK
Languages: English
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CE.way Verified

CE.way offers regulatory and testing solutions for cosmetic products in the EU, UK, and other markets. Services include EU/UK Responsible Person, CPNP/SCPN notifications, PIF management, CPSR, safety and efficacy testing, and GPSR compliance. In-house lab for stability, challenge, microbiology, and SPF testing. Members of Cosmetics Consultants Europe, Society of Cosmetic Scientists, and CTPA.

At CE.way we help you bring your cosmetic products to the market quickly and efficiently. With a combination of our know-how and in-house lab facility, we offer regulatory consulting and testing services and seamlessly navigate you through the registration process in the European Union, United Kingdom, USA, USA OTC, Canada, ASEAN, China, Saudi Arabia, UAE, Gulf Cooperation Council, India, and other markets. Services include: EU & UK Responsible Person (RP), CPNP/SCPN notifications, Product Information File (PIF) compilation and maintenance, formula compliance, safety assessments (CPSR), stability and compatibility testing, challenge testing, microbiology testing, efficacy testing, GPSR (General Product Safety Regulation) compliance, and European representative for companies not located in Europe. We perform safety and efficacy testing in our own in-house laboratory using state-of-the-art techniques and consumer perception tests.
Website: ceway.eu
HQ: Dublin, EU
Jurisdictions: EU
Countries: SI, AT, DE, FR, IT, NL, GB, IE
Languages: English
Response SLA: 48 hours
Onboarding time: 2–7 days
Pricing model: Retainer
Starting from: EUR 350
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Comprehensive Buyer's Guide

1. Who Needs a GPSR Responsible Economic Operator?

Non-EU brands and manufacturers placing consumer products on the EU or Northern Ireland markets must have a responsible economic operator established in the EU/NI.[1] This can be a manufacturer, authorized representative, importer, or fulfillment service provider within the supply chain.

If no EU/NI economic operator is already established, a GPSR representative service can act as the responsible economic operator so your products can be placed on the market.[1]

References

  1. EU Regulation 2023/988 on General Product Safety: detailed guidance (UK Government (OPSS)) — 2024-12-13 — Responsible economic operator

2. Labeling and Contact Details Requirements

The responsible economic operator's name (or registered trade name/trademark) and contact details, including postal address, must be indicated on the product, its packaging, the parcel, or an accompanying document.[1] This is a core requirement for market access and marketplace listings.

References

  1. EU Regulation 2023/988 on General Product Safety: detailed guidance (UK Government (OPSS)) — 2024-12-13 — Responsible economic operator contact details

3. What to Compare When Selecting a GPSR Representative

  • EU/NI establishment: country of establishment and ability to be listed as the responsible economic operator.
  • Product category fit: experience with your product types and safety documentation needs.
  • Marketplace support: ability to meet marketplace listing requirements and support cross-border sales.
  • Incident & recall support: communication workflows, response SLAs, and corrective action support.

4. When Does GPSR Apply?

The General Product Safety Regulation (EU) 2023/988 applies from 13 December 2024.[1] Products placed on the market before that date under the previous directive may benefit from transitional provisions.

References

  1. General product safety regulation (2023) summary (EUR-Lex) — 2023-05-10 — From when does the regulation apply?

Frequently Asked Questions

Q1: What is a GPSR Responsible Economic Operator?

A GPSR responsible economic operator is an economic operator established in the EU or Northern Ireland that is responsible for compliance duties for products placed on the EU/NI market. If no manufacturer, authorized representative, or importer is established in the EU/NI, a fulfillment service provider can act as the responsible economic operator.[1]

References

  1. EU Regulation 2023/988 on General Product Safety: detailed guidance (UK Government (OPSS)) — 2024-12-13 — Responsible economic operator

Q2: Do I need the responsible economic operator's address on labels or packaging?

Yes. The responsible economic operator's name (or registered trade name/trademark) and contact details, including postal address, must be indicated on the product, packaging, parcel, or an accompanying document.[1]

References

  1. EU Regulation 2023/988 on General Product Safety: detailed guidance (UK Government (OPSS)) — 2024-12-13 — Responsible economic operator contact details

Q3: When does GPSR apply?

The General Product Safety Regulation (EU) 2023/988 applies from 13 December 2024.[1]

References

  1. General product safety regulation (2023) summary (EUR-Lex) — 2023-05-10 — From when does the regulation apply?

Q4: Can one responsible economic operator cover both EU and Northern Ireland?

Yes. Guidance notes that a single responsible economic operator can be used for supply of products in both the EU and Northern Ireland, regardless of which of the two jurisdictions it is established in.[1]

References

  1. EU Regulation 2023/988 on General Product Safety: detailed guidance (UK Government (OPSS)) — 2024-12-13 — Responsible economic operator

Related Regulatory Services

EU Authorized Representative (EU AR) UK Responsible Person (UK RP) Swiss Authorized Representative (CH-REP) Person Responsible for Regulatory Compliance (PRRC) EU+UK Cosmetics Compliance DSA Article 13 Representative

Provider Comparison Table

Provider CoverageKey Features Languages Response SLA
International Associates Limited EU, UK Request quote English Request quote
QLE EU Request quote Request quote
ELS Group EU, UK Request quote 24h
Obelis Group EU, UK Request quote English, French Request quote
MDSS (EC REP) EU Request quote English, German Request quote
Euverify Verified EU, UK Request quote English Request quote
CE.way Verified EU, EU+NI Request quote English 48h

Sources & Official Guidance

Official sources vary by directory. See the applicable regulation and competent authority guidance for this role.

Last Updated: 2026-04-19
Reviewed by: Cruxi Regulatory Affairs Team
Cruxi - Regulatory Compliance Services