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!

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Our Industries as Authorized Repre­sentative

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Medical Devices

In the European Union, medical devices play a pivotal role in enhancing the well-being of individuals and stand as one of the largest global markets. The regulation of medical devices within the EU is overseen by EU Regulation 2017/745. Engaging the services of a European Authorized Representative (EC REP) for EEA member states is a mandatory step in compliance with the European Medical Device Regulations, particularly MDR (EU) 2017/745. This ensures alignment with key aspects of the CE marking criteria.

In Vitro Diagnostics

Before introducing in-vitro diagnostic products to the EU market, ensure they comply with EU regulations for 'in-vitro diagnostics.' Non-EU manufacturers must appoint an Authorized Representative under IVDR for market access and compliance. Engaging the services of a European Authorized Representative (EC REP) for EEA member states is a mandatory step in compliance with the European Medical Device Regulations, specifically the In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746). This ensures alignment with key aspects of the 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

Explore our range of specialized protective gear, encompassing items like safety goggles, gloves, helmets, and masks, designed to shield against an array of hazards. From industrial settings to sports, our gear safeguards against biohazards, extreme temperatures, physical impacts, electrical risks, chemical exposure, and airborne contaminants.

Our 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.

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Contact Us

Our customer service team, made up of professional PhD biologists and medical engineers, are well equipped to deal with your enquiries. Talk to us and we will find a solution to your inquiries.

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