Your gateway to the EU market - Our EU Authorized Representative/EC-REP

Are you a non-EU manufacturer and would like to place your medical devices or in vitro diagnostics (IVD) on the EU market? Then you need an EC-REP (EU Authorized Representative) according to the European Medical Device Regulations (MDR) or In Vitro Diagnostic Device Regulations (IVDR) according to Article 11.

CEyoo stands alongside you as a reliable EU-REP and takes over the clear duties of the European Community Representative (EC-REP) or European Authorized Representative (EAR). This allows you to easily meet the requirements of the MDR and IVDR and gain smooth access to the EU market.

Start now and talk with our EU-REP experts to achieve your regulatory goals for the EU!

Questions and answers about the role of the European Authorized Representative (EAR, EC-REP, EU-REP)

What is the role of the European Authorized Representative (EC-REP)?

The European Authorized Representative, also known as the EC-REP, plays a crucial role for non-EU manufacturers of medical devices and IVDs. The EC-REP is a legally responsible person based in the EU and acts as a representative for a non-EU manufacturer. He is responsible for ensuring compliance with the Medical Device Regulation (MDR) or the In Vitro Diagnostic Device Regulation (IVDR) under Article 11.

Why do I need a European Authorized Representative(EC-REP)?

As a non-EU manufacturer, you are legally obliged to have an EU-REP if you want to place your medical devices or in vitro diagnostic (IVD) products on the EU market. The EC-REP takes legal responsibility on your behalf and ensures compliance with EU requirements.

Our EC-REP service allows you to focus on what's important - driving your business forward. We look forward to supporting you in entering the European market.

Silke Müller, Operations Manager

EC-REP: The Essential Requirement for Non-European Manufacturers to Access the EU Market

Without a European Authorized Representative (EC-REP), access to the EU market is restricted. An EC-REP/EU-REP is the crucial requirement for non-EU manufacturers to sell their products

What are the benefits of working with CEyoo as our European Authorized Representative(EC-REP)?

CEyoo has extensive experience and expertise in the field of regulatory compliance for medical devices and IVDs. With us as your EC REP, you can confidently navigate the complex EU regulatory environment and ensure smooth market access and compliance with all requirements.

How does CEyoo support us as our European Authorized Representative(EC-REP)?

CEyoo offers comprehensive services as your EC-REP - including document management, post-market surveillance, reporting to competent authorities - and as a link between your company and EU regulators.

We are a medical device company and want to distribute our product(s) in the Swiss market. Can you also act as our authorized representative for Switzerland?

Yes, in addition to our EU-REP service,we can also act as CH-REP (Swiss Authorized Representative) for medical devices and IVDs with our Metecon Switzerland GmbH and ensure compliance with Swiss regulations and facilitate market access in Switzerland. Our Metecon Switzerland GmbH is responsible for this.

How can I get started with Metecon as our European Authorized Representative?

Getting started is easy! Contact us free of charge and without any obligation to discuss your specific requirements and regulatory needs. Our team will guide you through the process and ensure a smooth and successful partnership as your EU-REP.

Our EU-REP service is the key to your success in the EU. We stand by your side as a reliable partner to ensure compliance and facilitate market access.

Dr. Kerris Klug, Business Development

We look forward to meeting you!