Authorized Representative Service for CE Certified Devices

European authorized representative (EC REP) package is intended for companies that have already obtained the CE certificate for their devices or already compiled the technical file (for class I devices). In such cases, we only need to compile certain documents that we have to hold as your EAR (EC REP), review them, perform notification of your products to the competent authority, and act as your EAR, performing all of the functions of the EAR. If you already have the CE certificate then this package includes all the essential services that enable you to sell your products in the EU.

1- Revipharm is appointed as the Authorized Representative (EC REP) for your medical devices in the EU (and performs all the tasks related to being the Authorized Representative).

2- Revipharm reviews your CE certificate.

3- Revipharm reviews the products’ Instructions for use (also provides guidance on the labeling requirements and checks the conformity of your labels with the EU Directive).

4- Revipharm reviews your CE Declaration of conformity.

5- Revipharm performs the notification of your products to the competent authority.

Who is Authorized Representative service (EC REP) for CE certified devices intended for?

Any non-EU medical device manufacturers that would like to sell their products in the EU and have already obtained the CE certificate or prepared the technical file (for class I devices).

EU medical device manufacturers/importers who are not familiar with the relevant legislation and/or would like to outsource the function of the Authorized Representative, and already have the CE certificate for their devices.

Contact us to find out more about the Authorized Representative service (EC REP) for CE certified devices and to receive a quote.

Other related links:

• Medical Device / IVD Classification
• Vigilance system implementation
• Guidance on labelling requirements
• ¿Cómo afectará el Reglamento Europeo a la vigilancia de Productos Sanitarios?
• Solicitud del Código Nacional de Parafarmacia
• Comunicación de puesta en el mercado de productos sanitarios
• Registro de Responsables de la puesta en el mercado de productos sanitarios
• Licencia previa de funcionamiento de instalaciones de productos sanitarios: fabricación, esterilización, agrupación e importación
• Importación de productos sanitarios
• Sistema de vigilancia de productos sanitarios
• Licencia de fabricación de productos sanitarios a medida

Update date: 15-06-2015