The Single Source to all European Markets
Acting as your European Authorized Representative, UK Responsible Person and Swiss Authorized Representative, we enable you to get access to all european markets. No matter if you want to place a product on the market or to conduct a study, MedNet handles all your regulatory needs in one hand.
Our Industries as European Authorized Representative
In order to place a product on EU markets, non-EU manufacturers are required by local regulations to appoint an authorized representative as a local contact for competent authorities. Based in Germany, the UK and Switzerland, we can guarantee fast communication channels as well as a deep understanding of local regulations. This is how we get your product to market quickly and safely!
Medical Devices
In the EU, medical devices are vital for well-being and a major global market. Regulation is governed by EU Regulation 2017/745. Hiring a European Authorized Representative is mandatory for compliance, especially with MDR (EU) 2017/745, ensuring adherence to CE marking criteria.
In Vitro Diagnostics
Ensure EU market compliance for in-vitro diagnostic products by meeting EU regulations. Non-EU manufacturers need an Authorized Representative under IVDR. Engage a European Authorized Representative for EEA states to comply with IVDR (EU) 2017/746, aligning with CE marking criteria.
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Cosmetics
Cosmetics and personal care products in the EU fall under the regulations of Cosmetics Regulation 1223/2009. MedNet EC-Rep has been a trusted partner for numerous cosmetic brand owners, providing expert guidance throughout their compliance journey.
Personal Protective Equipment
Personal Protective Equipment rollouts are governed by EU Regulation 2016/425, specifying access for non-EU PPEs to the EU. It mandates appointing a European Authorized Representative (EC-REP) for market placement. MedNet, your partner, serves as the initial contact, aids in regulatory navigation, and provides updates on rule changes.
Why choose MedNet EC-REP as your Authorized Representative?
Expert Team
Professional scientists and engineers.
Experience
Over 30 years in the healthcare business.
Global Reach
Serving 700+ customers worldwide.
Certified Quality
ISO 13485 certified, ensuring the highest standards in quality management for medical devices.
Regulatory Expertise
In-depth knowledge of European regulatory requirements.
Personalized Support
Tailored services to meet your unique compliance needs.
European Authorized Representative Services
MedNet EC-REP provides top-notch services as a European Authorized Representative (EC-REP), UK Responsible Person, and Swiss Authorized Representative. We specialize in medical devices, in vitro diagnostics, cosmetics, and personal protective equipment. Our team ensures fast and efficient market entry, compliance with EU regulations, and comprehensive support for regulatory affairs.
EC-REP Service
We act as your European Authorized Representative (EC-REP) for seamless entry of Medical Devices, IVDs, and PPE into the EU market. Benefit from expedited product registration and Free Sales Certificate legalization.
Responsible Person Service
Accelerate your cosmetic product sales in the EU and UK with our Responsible Person service, ensuring swift CPNP and OPSS registrations.
Legal Representative Service
As your Legal Representative, we streamline the approval process for your EU Medical Device / IVD studies, ensuring quick study approval.
Product Registration
Achieve rapid and straightforward product registrations across all EU countries, including Great Britain and Switzerland, with our expert services.
Free Sales Certificate
Get comprehensive and quick Free Sales Certificate services, including global legalizations as required.
Your Trusted Partner
for European Market Access
With over 30 years of experience, we are your trusted partner.
Let us fulfill your regulatory needs in one go.
Contact us today and request a quote!
Latest News
Stay informed about the latest developments impacting the medical device industry and cosmetic market. Explore current trends and access essential information on our upcoming events and exhibitions.
MedNet EC-REP GmbH to Exhibit at MEDICA 2024 in Düsseldorf
We are excited to announce its participation at MEDICA 2024, the world’s leading trade fair for the medical industry, taking place from November 11th to 14th in Düsseldorf, Germany.
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MedNet EC-REP GmbH Successfully Renews ISO 13485:2016 Certification
We are pleased to announce that MedNet EC-REP GmbH has successfully renewed its ISO 13485:2016 certification.
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Key Changes in MDCG 2022-4 Rev 2 for Medical Device Manufacturers
The European Commission has issued the revised MDCG 2022-4 guidance, focusing on appropriate surveillance during the transition from the MDR
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Deadline Alert: Submission Requirements for MDR Conformity Assessment
Important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607.
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