MedNet EC-REP
MedNet EC-REP GmbH
Verified
MedNet EC-REP is your partner for regulatory representation in the European markets, providing seamless access for non-EU products to the EU, Great Britain, and Switzerland.
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).<br><br>- **Who they are**<br>MedNet EC-REP GmbH is an established EU Authorized Representative based in Germany, providing regulatory affairs expertise for market entry and sustained compliance.<br><br>- **Expertise & scope**<br> - EU and UK regulatory representation for cosmetics, medical devices, and IVDs.<br> - Ensuring compliance with EU MDR and IVDR regulations.<br> - Support for product registration in national databases across the EU, UK, and Switzerland.<br> - Assistance with obtaining Free Sales Certificates (FSC) for global market access.<br> - Responsible Person services for cosmetics, ensuring compliance with EU and UK regulations.<br> - GPSR (General Product Safety Regulation) Responsible Person services for consumer goods not covered by specific EU laws.<br> - Liaison with regulatory authorities and management of incident reports.<br> - Labeling support for cosmetics to ensure accuracy and compliance.<br><br>- **Reputation / proof points**<br> - 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
- Offers over 30 years of experience in regulatory representation for the European Union, Great Britain, and Switzerland.
- Provides a dedicated Responsible Person service for cosmetics to ensure compliance with EU and UK regulations.
- Specializes in EC-REP and UK-RP services for medical devices and in vitro diagnostic devices.
- Assists with product registration in national databases for the EU, UK, and Switzerland.
- Offers GPSR Responsible Person services for general product safety compliance across the EU.
Certifications & Trust Signals
- Established EU Authorized Representative with headquarters in Germany.
Buyer Snapshot
Best for
- Non-EU manufacturers seeking EU/UK market access for medical devices, IVDs, or cosmetics.
- Companies needing a local EU/UK address for regulatory purposes.
- Businesses requiring assistance with product registration and compliance documentation.
How engagement typically works
- Proactive regulatory guidance and support.
- Facilitation of communication with competent authorities.
- End-to-end service for market entry and compliance.
Typical deliverables
- EC-REP / UK RP appointment and ongoing representation.
- Product registration certificates.
- Free Sales Certificates.
- Cosmetics notifications (CPNP/OPSS).
- GPSR compliance support.
Good to know
- Best when manufacturers require a dedicated EU/UK entity to fulfill regulatory obligations.
Facts
Examples & Achievements
- More than 700 clients worldwide
- Team creatd by regulatory experts
- Team creatd by regulatory experts
HQ:
Germany, DE
Website:
mednet-ecrep.com
Public email:
Juliana.Jonitz@medneteurope.com
Phone:
+49-251-322-66-64
Languages:
English, German, Portuguese
Timezones:
Europe/Berlin
Access:
Verified
Claim status:
Claimed
Services & Capabilities
EU+UK Cosmetics Compliance
Jurisdictions:
EU, UK, CH
Countries:
DE, NL, BE, FR, IT, ES, PL, IE
Industries:
Cosmetics, Personal care, Beauty
Response SLA:
48 hours
Onboarding time:
1–3 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 2,475
Included services:
EU Responsible Person - Cosmetics, UK Resposible Person - Cosmetics, CPNP Notification, SCPN Notification, Incident report assistance
Supports CPNP:
Yes
Supports PIF:
No
Product Categories:
Medical Devices, In Vitro Diagnostics, Cosmetics, Personal Protective Equipment, Software, Class I, Class IIa, Class IIb, Class III, Active devices, GPSR
Label Review Included:
Yes
Supports CPSR:
No
Supports Regulatory Consulting:
No
Supports Formula Compliance Checks:
No
Supports Testing Coordination Management:
No
Supports Claims Substantiation:
Yes
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
Yes
Turnaround SLA:
1-3 days
eu_ar
Jurisdictions:
EU, UK, CH
Countries:
Italy, Spain, Netherlands, Portugal, France, Belgium, Germany, Austria
Industries:
Medical devices, IVD, SaMD
Portfolio:
1-5, 6-25
Response SLA:
48 hours
Onboarding time:
1–3 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 2,475
Included services:
UDI support, Label review, EUDAMED registration, Document retention, Vigilance support, Regulatory support
Alternate Names:
EAR, AR, European Authorized Representative, EU-REP
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class IIb, Class Is/Im/Ir, Class III, IVD, Class IIa
Post Market Support:
No
Labeling Review:
Yes
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
uk_rp
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices
Response SLA:
48 hours
Onboarding time:
1–3 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 2,475
Supports GB:
Yes
Supports NI:
No
Device Classes Supported:
Class I, Class III, Class IIa, IVD, Class IIb
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
ch_rep
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices
Portfolio:
1-5, 6-25
Pricing model:
Per SKU
eudamed_reg_support
Jurisdictions:
EU
Countries:
DE
Industries:
Medical devices
Portfolio:
1-5, 6-25
Pricing model:
Per project
importer_distributor_compliance
Jurisdictions:
EU
Countries:
DE, AT, NL, BE, FR
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
6-25, 26-100
Response SLA:
48 hours
Onboarding time:
2–22 days
Pricing model:
Retainer
Starting from:
EUR 2,800
Included services:
Importer/Distributor SOP & template pack, Training for economic operator obligations, Compliance gap scan, Audit readiness support, Ongoing compliance support
Deliverables:
Ongoing retainer
Role Coverage:
Importer
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
Requires appointment of an EU-based authorized representative (EC-REP) for medical devices and IVDs, and a UK-based Responsible Person (UK RP) for non-UK manufacturers post-Brexit. Assistance is provided for product registration and compliance documentation.
⚡ Instant booking available
Appoint an EU or UK Cosmetics Responsible Person Online
Compare MedNet EC-REP and other vetted providers — instant pricing, no RFQ needed.
