MedNet EC-REP
MedNet EC-REP GmbH
MedNet EC-REP is your expert partner for EU and UK regulatory representation, specializing in cosmetics, medical devices, and IVDs. They ensure seamless market access and compliance across European markets.
MedNet EC-REP GmbH provides comprehensive regulatory representation services for non-EU manufacturers seeking to access European markets, including the EU, Great Britain, and Switzerland. They specialize in ensuring compliance for a wide range of products, including cosmetics, medical devices, and in vitro diagnostics (IVDs). As your European Authorized Representative (EC-REP) and UK Responsible Person (UK RP), MedNet EC-REP facilitates product registration, manages regulatory inquiries, and ensures sustained compliance throughout your product's lifecycle. Their expertise covers key regulations such as the EU Cosmetics Regulation (1223/2009), MDR (EU) 2017/745, and IVDR (EU) 2017/746. With a strong presence in Germany, MedNet EC-REP offers expert guidance, product registration services in national databases (including CPNP and OPSS), and acts as a crucial liaison with competent authorities. They are committed to providing swift market entry, maintaining product safety, and keeping clients updated on evolving regulatory landscapes.
About
MedNet EC-REP GmbH is a regulatory representation specialist with over 30 years of experience, focusing on helping manufacturers navigate market access and compliance in the EU, UK, and Switzerland. They offer a comprehensive suite of services including acting as an EU Authorized Representative (EC-REP) and UK Responsible Person (UK RP) for medical devices and in vitro diagnostic devices (IVDs).
- **Who they are**
MedNet EC-REP GmbH is an established EU Authorized Representative based in Germany, providing regulatory affairs expertise for market entry and sustained compliance.
- **Expertise & scope**
- EU and UK regulatory representation for cosmetics, medical devices, and IVDs.
- Ensuring compliance with EU MDR and IVDR regulations.
- Support for product registration in national databases across the EU, UK, and Switzerland.
- Assistance with obtaining Free Sales Certificates (FSC) for global market access.
- Responsible Person services for cosmetics, ensuring compliance with EU and UK regulations.
- GPSR (General Product Safety Regulation) Responsible Person services for consumer goods not covered by specific EU laws.
- Liaison with regulatory authorities and management of incident reports.
- Labeling support for cosmetics to ensure accuracy and compliance.
- **Reputation / proof points**
- Over 30 years of experience in the European Union, Great Britain, and Switzerland.
- **Who they are**
MedNet EC-REP GmbH is an established EU Authorized Representative based in Germany, providing regulatory affairs expertise for market entry and sustained compliance.
- **Expertise & scope**
- EU and UK regulatory representation for cosmetics, medical devices, and IVDs.
- Ensuring compliance with EU MDR and IVDR regulations.
- Support for product registration in national databases across the EU, UK, and Switzerland.
- Assistance with obtaining Free Sales Certificates (FSC) for global market access.
- Responsible Person services for cosmetics, ensuring compliance with EU and UK regulations.
- GPSR (General Product Safety Regulation) Responsible Person services for consumer goods not covered by specific EU laws.
- Liaison with regulatory authorities and management of incident reports.
- Labeling support for cosmetics to ensure accuracy and compliance.
- **Reputation / proof points**
- Over 30 years of experience in the European Union, Great Britain, and Switzerland.
Additional information
MedNet EC-REP facilitates market entry by acting as the essential link between manufacturers and regulatory bodies. For non-EU manufacturers, appointing an EC-REP is a mandatory requirement for placing medical devices and IVDs on the EU market. They also provide crucial support for product registration, ensuring products meet national database requirements. For cosmetics, their Responsible Person service ensures adherence to EU and UK regulations, including CPNP notifications in Europe and OPSS registrations in the UK. Their services extend to GPSR compliance, covering a broad range of consumer goods that require safety assurance across the EU.
Key Highlights
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Offers over 30 years of experience in regulatory representation for the European Union, Great Britain, and Switzerland.
Source
“With over 30 years of experience we are your trusted partner in the european Union, Great Britain and Switzerland.”
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Provides a dedicated Responsible Person service for cosmetics to ensure compliance with EU and UK regulations.
Source
“We offer a comprehensive Responsible Person Service for manufacturers aiming to sell cosmetics in the European Union and the UK.”
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Specializes in EC-REP and UK-RP services for medical devices and in vitro diagnostic devices.
Source
“For medical devices and in vitro diagnostic devices, the EU Regulations (MDR and IVDR) require that non-EU manufacturers appoint an EU-based authorized representative”
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Assists with product registration in national databases for the EU, UK, and Switzerland.
Source
“We help you to register your products in the national databases.”
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Offers GPSR Responsible Person services for general product safety compliance across the EU.
Source
“As an established EU Authorized Representative with expertise in regulatory affairs, we offer a comprehensive Responsible Person service tailored to GPSR compliance.”
Certifications & Trust Signals
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Established EU Authorized Representative with headquarters in Germany.
Source
“With our EU headquarters in Germany, we are based in the geographic heart of the Union”
Buyer Snapshot
Best for
- Non-EU manufacturers seeking EU/UK market access for medical devices, IVDs, or cosmetics.
- Companies needing a dedicated EU Authorized Representative or UK Responsible Person.
- Manufacturers requiring assistance with product registration and compliance documentation.
How engagement typically works
- Proactive regulatory support and liaison.
- End-to-end compliance management.
- Facilitation of market entry and ongoing adherence.
Typical deliverables
- EC-REP / UK RP appointment and services.
- Responsible Person services for cosmetics and GPSR.
- Product registration support.
- Free Sales Certificate application assistance.
- Labeling compliance review.
Good to know
- Best when manufacturers require a local EU/UK entity to act as their representative.
- Requires manufacturers to provide necessary product and compliance data for applications and registrations.
HQ:
Germany, DE
Languages:
English, German
Timezones:
Europe/Berlin
Status:
listed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
EU, UK
Countries:
DE, NL, BE, FR, IT, ES, PL, IE
Industries:
Cosmetics, Personal care, Beauty
Portfolio:
1-5, 6-25
Onboarding time:
1–3 days
Pricing model:
Per SKU
Starting from:
EUR 300
Included services:
Responsible Person role coverage, CPNP notification support, Product Information File (PIF) support, Label review (INCI and mandatory statements), Post‑market compliance and incident escalation
Supports CPNP:
Yes
Product Categories:
Medical Devices, In Vitro Diagnostics, Cosmetics, Personal Protective Equipment
Label Review Included:
Yes
Supports Ukcosmetics Rp:
Yes
Supports CPSR:
Yes
Supports Claims Substantiation:
Yes
Additional cosmetics_rp Details
Supports CPNP
Yes
Supports PIF
No
Supports CPSR
No
Markets Covered
EU, UK
Can Provide Local Address On Label
Yes
Label Review Included
Yes
Onboarding Steps
The process involves appointing MedNet EC-REP as the EC-REP or UK RP, providing necessary product compliance data, and MedNet managing registrations and regulatory communications.
