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What are the Responsibilities of the European Authorized Representative

The responsibilities of the Authorized Representative are:

  • Assisting European Authorities in communications with foreign establishments
  • Assisting European Authorities in scheduling inspections of the foreign establishment
  • Handle reports concerning vigilance activities or product recalls
  • Maintain a technical file
  • On top of these Authorized Representative services we can also provide consulting services for writing or reviewing Technical Files

References for the need to appoint a Regulatory Authorized Representative

  • The European Medical Device Directive 93/42/EC Article 14
  • The European IVDD Directive 98/79/EC Article 10.

Once you have appointed your Authorized Representative and completed your CE requirements, you will be requested to:

  • Report any case that meets the reporting requirements to the Authorities. The criteria and procedures of such reporting will be provided by us. In accordance with the Directives, the Authorized Representative reports to the Authorities.
  • Update your labelling (product / user manual / packaging) with the details of your Authorized Representative offices. Labelling instructions and guidelines will be provided by us.
  • For class I devices in Europe, you will also need to provide us with a copy of the product Technical Files. In accordance with the Directives the Authorized Representative keeps this information available for the Authorities.

Service we provide:

Manufacturer registration and product listing (CE marking) of all your medical products with the Regulatory Authorities.
  • Adverse Incident and Recall Reporting of products with CE marking to the Regulatory Authorities.
  • Handling of customer complaints received through the regulatory authorities regarding products with CE marking.
  • Consultation services regarding CE marking of any medical device or laboratory equipment: Regulatory / QA / Product Compliance.

More info:

You can find more information on this page
If you are looking for a European Representative and wish to sell in Europe you can contact usfor a preliminary discussion