What in the world is an EU Authorised Representative?
The basic principle of the EU product legislation is that no matter of the origin of the product, it needs to comply with EU legislation.
In medical device sector it means products must comply to the EU Medical Device Regulation.
In general, the Authorities in EU have the obligation to oversee this compliance when products are imported to EU.
In medical device sector, part of these Authority duties has however been given to an actor called EU Authorised Representative.
In practice, EU Authorized Representative performs some of the required compliance checks, and acts as a link between EU Authorities and non-EU medical device manufacturers.