EU Authorised Representative

Every medical device 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 ten per annum)

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