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An Authorized Representative in the European Union for your Medical Products

 

As a legal interface between the Medical Device manufacturer and the EU Authorities, the European Authorized Representative is responsible towards the European government, representing the manufacturer in all European regulatory affairs.

 

Authorized Representative

 

The Medical Device manufacturers established outside the EU must appoint a single authorized representative established in the European Union to act on his behalf.

Our legal entities in UK can be used as local representatives. We ensure our contact information is available to the you to be placed on all the products they are representing, thus acting as a primary contact for your EU Authorities.

 

Obtain the European Free Sales Certificate (FSC)

 

This certificate should be submitted by the manufacturer itself to the non-European country intended to market your products.

Only the Authorized Representative is able to obtain the Free Sales Certificate (FSC) / Certificate of Marketability on behalf of the manufacturer. It is issued by the Competent Authority of the EU member state where authorized representative in Europe.

 

Keep and Update Your Technical Files

 

Make sure the technical file and documentation are available for 10 years (medical devices) and 15 years (implantable devices) after the last device placed on the market. We keep and update the product’s documentations for CE marking of your products is available at any time for the EU member states authorities.

The information about the product must be updated whenever it changes. We update your technical documentation of your products sold in Europe.

 

Legislation Monitoring

 

We monitor and report on new developments in European product legislation relevant to your products. We understand all EU regulations from each of the twenty-seven EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.

 

Notification to EU Authorities

 

We notify EU Authorities of all major incidents pertaining to products.

 

Vigilance and Incident Reporting

 

We assist with product vigilance and incident reporting.

 

Product Recalls and Advisory Notices

 

We assist with Product Recalls and the issuing of Advisory Notices

We understand all EU regulations from each of the twenty-seven EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.


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