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Your Authorized Representation for Europe

MedNet EC-REP is your partner for the regulatory representation of your product on the European markets. We provide uncomplicated handling and quick access for non-EU products to be placed in the European Union, Great Britain and Switzerland.

The single source
to all EU markets

Acting as your European Authorized Representative, UK Responsible Person and Swiss Authorized Representative, we enable you to get access to all EU 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.

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!

30+

Years of experience

700+

Customers worldwide

EU-REP

Our Industries as Authorized Repre­sentative

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.

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.

Services

Our services support you in gaining access to the European, British and Swiss markets by providing all the important regulatory services you need for a successful roll out.

Explore all
EC-REP Service

We serve as your EC-REP for EU market entry of Medical Devices, IVD, PPE. We offer fast product registration and Free Sales Certificate legalization.

Responsible Person Service

We expedite your EU/UK cosmetic sales as your Responsible Person with swift CPNP and OPSS registrations.

Legal Representative Service

We facilitate your EU Medical Device/IVD study as Legal Representative, ensuring swift study approval.

Product Registration

We ensure rapid, simple registrations across all EU countries, including Great Britain and Switzerland.

Free Sales Certificate

We provide comprehensive, quick Free Sales Certificate services, including legalizations worldwide as needed.m tristique.

Success Stories

Join the team

We believe in the power of a strong and motivated team. We are looking for talented people to join us in our mission of shaping the future of healthcare. Browse our vacancies to find the job that matches your skills and ambitions.

Current Vacancies
Mednet EC-REP Team

Current News

Key Changes in MDCG 2022-4 Rev 2 for Medical Device Manufacturers

Key Changes in MDCG 2022-4 Rev 2 for Medical Device Manufacturers

The European Commission has issued revised guidance (MDCG 2022-4). Key highlights include alignment with EU 2023/607 and explicit outlines for legacy device audits. Stay informed by reading the full guidance here.

Deadline Alert: Submission Requirements for MDR Conformity Assessment

Deadline Alert: Submission Requirements for MDR Conformity Assessment

We're pleased to provide you with important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607.

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New Website

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