ASECONSA available to customers outside their service EUROPEAN AUTHORIZED REPRESENTATIVE of medical devices.

All medical devices (active and in vitro included) manufactured outside the European Union must have a representative (EC REP) in the European Union based in any member state to be appointed by the manufacturer of medical devices representative in writing.

This representative must perform the obligations under the European Union's Medical Devices Regulation 2017/745 for medical devices . The EU authorized representative must contact the authorities at the time of notification for placing on the market of medical devices class IIa, IIb and III.

This charge of medical devices marketed in the European Union should act as business partner for the EU health authorities and have available all information concerning medical products imported into the seat communicated in a member state . One of the functions to be performed is the management and organization of the claims and actions of monitoring the health products put on the market for the company 's representative.

Within the service include:

• Postal Service Headquarters and in the European Union.
• Management and establishment of monitoring procedures.
• Evaluation Technical file and labeling.
• Management CE marked and declaration of conformity.
• Administrations in dialogue with health and notified bodies.
• Communication placing on the market of medical devices.
• Document Management file.
• Supervision and training of distributors.

Contact us if you wish us to provide you an adequate budget to the needs of your business to perform the duties of Authorized Representative in the European Union of its products.

Otros servicios de ASECONSA relacionados:

Clases de productos sanitarios.

Licencia de importación de productos sanitarios.

Licencia de fabricación, esterilización, agrupación e importación de productos sanitarios.

Requisitos para importar productos sanitarios.

Comunicación de puesta en el mercado de productos sanitarios.

Consultoría de productos sanitarios II: Technical File (TF).