Learn Everything You Need to Know about EC Representative

by Cert3 Global Cert3Global

To comply with the CE standards for putting medical products on the EU market, manufacturers of medical devices based outside the EU must name an Authorized Representative (EC-REP) established inside the EU.

The EC-REP serves as these manufacturers' primary point of contact because they are based in the Union. The approved person will be informed in the event that the EU authorities make a request, and they will make sure that the necessary information is delivered and managed properly.

The EC-REP's (EU Authorized Representative) function

Before selling medical equipment and IVDs in Europe, foreign firms must appoint an EU Authorized Representative (AR).

The European Union AR serves as the manufacturer's regulatory representative in the European Single Market and serves as the manufacturer's point of contact with the European national Competent Authorities. An EAR, EC Representative, EC Rep, or Authorised Representative are other names for the EU AR.

The MDR/IVDR expanded the EU AR's scope of authority. One notable modification is the clear joint obligation between the maker and AR for products placed on the market. A European Authorized Representative should be devoted to serving as your partner in the market given the importance of the AR role.

The MDR and IVDR have outlined the duties of the maker and the authorized representative in their articles 10, 11, and 12 due to the significance of the function of the authorized representative. In a mandate contract between the EC-REP and the manufacturer, those issues and others must be included.

It is in the best interests of both the manufacturer and the EC Rep to do thorough legal, regulatory, and technical due diligence before acting as an authorized representative for a manufacturer headquartered outside of the EU. In order to deliver a dependable service that offers value beyond the "Name on the Label," a close network and cooperation with the top liability insurance providers are essential.

Does my EC-REP also act as my representative in Switzerland and the United Kingdom?

The British government left the European Union. As a result, in order to advertise in the UK, manufacturers must now designate a separate UK Responsible Person.

For medical devices and IVDs, the Mutual Recognition Agreement between Switzerland and the European Union has expired. As a result, in order to market in Switzerland, producers must now designate a Swiss Authorized Representative (CH-REP).

While a single service provider is permitted to serve as your EU Authorized Representative, UK Responsible Person, and Swiss Authorized Representative, that provider is required to have a physical presence and be a legally recognized company in each region. The fact that Casus can support our clients across all three marketplaces makes the procedure more efficient.