Representative Services for your Medical Devices

No matter whether you intend to market your medical devices in the EU or Switzerland, we have the right Representative Service for you.

With our two sister companies, Metecon Switzerland LLC, and CEyoo GmbH, we can offer you both the service as a Swiss Authorized Representative (CH-REP) and as a European Authorized Representative (EC-REP/EU-REP).

As your CH-REP or EC-REP, we take care of ensuring that all legal requirements are met and provide support, if needed, in all matters related to regulatory compliance. As a manufacturer, you benefit from our ability to efficiently and effectively address our to-dos within the Metecon family, backed by the right experts for all tasks. This ensures that your medical device is effectively marketed, whether within Europe or in Switzerland.

Discover how we can support you as a Swiss Authorized Representative or EU Authorized Representative.

With Metecon Switzerland towards your CH-REP

Metecon Switzerland

Metecon Switzerland is your reliable partner for the regulatory compliance of medical devices and in-vitro diagnostics (IVD). For manufacturers not located in Switzerland and seeking access to the Swiss market, we serve as your Swiss Authorized Representative (CH-REP).

Our services for you in Switzerland

Swiss Authorised Representative (CH-REP): The solution for placing medical devices on the Swiss market

For manufacturers who wish to market their medical devices in Switzerland and do not have a presence in Switzerland, a Swiss Authorized Representative (CH-REP) is essential. This requirement applies to all manufacturers based in the EU since the Mutual Recognition Agreement (MRA) between the EU and Switzerland was not further extended. Therefore, a CH-REP is an indispensable condition for gaining access to the Swiss market. As a manufacturer, you have to appoint this authorised representative.

We are pleased to be your CH-REP!

What are our services as your Swiss Authorized Representative?

  • Verification of declarations of conformity and technical documentation, as well as conformity assessment procedures for the Swiss market.
  • Reporting of serious incidents and safety corrective actions to the relevant Swiss authority (Swissmedic) and submission of trend reports.
  • Communication with Swissmedic to assist you in ensuring the compliance of your medical devices with all necessary measures.
  • Coordination of Swissmedic inquiries regarding product samples or the conformity of specific products.
  • Collaboration with Swissmedic in all preventive or corrective actions and ensuring the cooperation of all relevant parties.
  • Prompt communication to you as soon as irregularities are identified.
  • Verification of compliance with registration requirements related to the unique product identification and the registration of the products in question.
  • Undertaking the document retention obligations as per the applicable regulations and as agreed.

Find out now how we can work together

With CEyoo for a Successful EC-REP

CEyoo

According to Article 11 of the MDR, CEyoo is at your service as a European Authorized Representative (EU-REP) to meet your requirements. Additionally, CEyoo takes care of the temporary placement of your medical devices on the market.

What we do for you as CEyoo

EU Authorized Representative: Why an EC-REP/EU-REP is Essential for Non-EU Manufacturers

Are you a manufacturer based outside the EU and planning to distribute your medical devices on the European market? Then you need an EU authorised representative (EU-REP/EC-REP) in accordance with the EU Medical Device Regulation (EU) 2017/745 (MDR). An EU-REP takes on the responsibility of ensuring compliance with the provisions of the MDR.

We provide you with professional EU Representative Service, facilitating your market access. With us as your partner, you can fully focus on your core business.

More details on the EC-REP

What are the services of the EU Authorized Representative at CEyoo?

  • Undertaking responsibilities towards EU authorities, including monitoring compliance with all relevant regulations.
  • Verification of declarations of conformity and technical documentation, as well as conformity assessment procedures for the European market.
  • Assumption of the document retention obligations for the required documents.
  • Communication with authorities during reviews related to product compliance.
  • Collaboration with authorities on all preventive or corrective actions and ensuring the cooperation of all relevant parties.
  • Immediate communication to you as soon as irregularities are identified.
  • Verification of compliance with registration requirements related to the unique product identification and the registration of the products in question.

Contact us for an initial, non-binding discussion