EC REP: European Authorized Representative.

Due to the increasingly common presence of imported medical devices in the European Union, the figure of the Authorized Representative (EC REP, European Authorized Representative) is becoming more common.

This figure must guarantee compliance with current regulations on medical devices for medical devices manufactured outside the European Union. 

Regulation 2017/745 of medical devices establishes the obligation for all manufacturers of medical devices established outside the European Union to have a permanent authorized representative who serves as an interlocutor for the European health authorities and has a documentary file with technical information. of medical devices (Technical file among others).

The authorized representative must be a natural or legal person based in an EU member state and appear on the labels of Medical Device CE Marking for sale in the EU. 

The appointment of this EC REP must be in writing along with its acceptance and in the case of class I products, this appointment must be communicated to the competent authority in the field of medical devices so that said authority can register it in the Registry of responsible parties. marketing of health products.

The authorized representative designated by the manufacturer of medical devices must keep the documentation referring to the products for a period of 5 years from the cessation of its commercialization of the medical device and 15 years in the case of implantable medical devices (intraocular lenses, prostheses of breast, hip, joints, spine, etc...).

I3CGLOBAL has extensive experience in medical device consulting and especially in international trade, serving as a permanent European Authorized Representative (EC REP) in the EU for its manufacturers of medical devices located outside the EU.

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