EC REP: European Authorized Representative. – I3CGLOBAL
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 increasingly common.
This figure must guarantee compliance with current regulations on medical devices for medical devices manufactured outside the European Union. Regulation 2017/745 on 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 (Medical Device TechnicalFile among others).
The authorized representative must be a natural or legal person based in a member state of the EU and appear on the labels of medical devices with CE marking for marketing in the EU.
The appointment of this EC REP must be in writing together with the acceptance of it 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 may register it in the Register of Responsible Parties. marketing of sanitary products.
The authorized representative designated by the manufacturer of medical devices must keep the documentation regarding the products for 5 years from the cessation of marketing 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 consulting for medical devices and especially in international trade, acting for its clients who manufacture medical devices based outside the EU as a permanent European Authorized Representative (EC REP) in the EU.
Why Choose I3CGLOBAL for European AuthorizedRepresentative?
We are the Best, Fastest, and Most Cost-Effective Medical Device EU Representative in Europe for EU Registration and Free Sale Certification
