Representante en la Unión Europea

Todo fabricante extracomunitario de productos sanitarios debe disponer de un representante autorizado en la unión europea autorizado y designado explícitamente por el propio l para que actúe en su lugar y a la que puedan dirigirse las autoridades sanitarias.

Europharma Regulatory Affairs S.L es una empresa con una de sus especializaciones en el ámbito de productos sanitarios además de estar radicada en la Unión Europea.

Authorised Representative

The authorised representatives appointed by the manufacturers must be established in the EC. The manufacturer may delegate tasks to the authorised representative, setting out the precise duties in writing for which he is delegating his responsability.

The authorised representative must be explicitly designated by the manufacturers to act on his behalf and to have responsability with regards placing the product on the market including dealing with the regulatory authority.

Europharma Regulatory Affairs S.L is an expert Company about Regulatory Affairs of Medical Devices as well as a Company placed in the European Union.