Representative Services for Your IVD: Smooth Market Access in the EU and Switzerland

Whether you're launching your IVDs in the EU or Switzerland, we offer the right representative services for you. Together with our affiliated companies Metecon Schweiz GmbH and CEyoo GmbH, we provide both Swiss Authorized Representative (CH-REP) and European Authorized Representative (EC-REP/EU-REP) services.

As your CH-REP or EC-REP, we ensure that all regulatory obligations are fulfilled. You benefit from seamless internal coordination and direct access to regulatory experts within the Metecon group. We don't just support compliance – we enable market success.

Secure your reliable CH-REP or EC-REP for IVDs today – with Metecon at your side.

With Metecon Switzerland towards your CH-REP

Metecon Switzerland: Your CH-REP for IVDs

Metecon Schweiz is your trusted partner for regulatory compliance in the Swiss IVD market. If you do not have a registered place of business in Switzerland, we act as your legally required Swiss Authorized Representative (CH-REP).

Explore our Swiss services

CH-REP: Your key to placing IVDs on the Swiss market

Since the EU-Switzerland Mutual Recognition Agreement (MRA) is no longer valid, IVD manufacturers based outside of Switzerland must appoint a CH-REP. We support you in gaining market access while meeting all applicable regulatory requirements.

We’re happy to be your CH-REP

Our CH-REP services for IVDs

  • 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.

Let’s talk about how we can work together

CEyoo: Your EC-REP for IVDs

CEyoo

CEyoo is your reliable point of contact under the IVDR for European Authorized Representative (EU-REP) services. We also support temporary placement of IVDs on the EU market.

Discover what CEyoo can do for you

EC-REP: Why non-EU IVD manufacturers need one

If you're based outside the EU and want to sell your IVDs in Europe, you must appoint an EU Authorized Representative according to the In Vitro Diagnostic Medical Device Regulation (IVDR, EU 2017/746). CEyoo takes on this role and ensures compliance with all applicable requirements.

More about our EC-REP services

Our EC-REP services for your IVDs

  • 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 consultation