European Authorised Representative
An Authorized representative is either a person or an entity who is responsible for placing the medical devices of a non EU manufacturer in EU market under his own name.
Does all the communication with the notified body and register his devices with competent authority.
European representative should be chosen with care as is responsible for activities like product registration and Products Recall, Vigilance, Market Surveillance etc. He also monitors the various post marketing and vigilance issues related to product and are the contact person on your behalf who is contacted by European authorities in case of emergencies.
We have legal offices in Netherlands and UK for providing this services