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european authorized representatives what are they what is the purpose and do you need in this video ill be breaking down for you what the requirements are for non-eu-based medical device manufacturers how you go about finding and appointing an appropriate eu authorised representative number one what is an eu authorised representative they are a natural or legal person or entity established within the european union who has accepted a written agreement from a manufacturer located outside the union they act on the manufacturers behalf within that region taking any shared responsibility for any legal obligations in regards to defective products placed onto the market number two why do you need an eu authorised representative for non-european union-based manufacturers it is a legal requirement to provide a suitable eu authorized representative prior to placing their products onto the market within the european union if you are a manufacturer based in the union or have no intention of sel