Every manufacturer based outside the EEA is legally required appoint an Authorized (or Authorised) Representative organisation within the EEA.
The Priory Analysts Authorised Representative service includes:
•    The legally defined duties of an Authorised Representative
•    EU regulatory support and advice. Since your product carries our name, we consider ourselves to be your EU Regulatory support.
•    Technical File contents review, including product label and package leaflet/instructions for use
•    EU regulatory updates (at least 10 per annum)
•    Inclusive consulting time
This service is called AR-paCE