EA Rep

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Duties of S.N. Pharma GmbH as Your European Authorized Representative (EC Rep / EA Rep)

 

The manufacturer and the European Representative work hand in hand providing and reviewing information and keeping all documents up-to-date. This is a constant process and S.N. Pharma will help you with the documentation, remind you to update the information and store everything to ensure everything is ready for a possible inspection.

 

  • Providing a registered address within the European Union
  • Advise on European Regulations
  • Keeping technical documentation available for inspection by the European Authorities
  • Completing notifications to European Authorities
  • Completing registrations to national German database which enables manufacturers to sell within the EEA
  • Representation of the manufacturer towards the European Commission, Authorities and Notified Bodies
  • Complaint management and incident reporting
  • Ensuring compliance with regular regulatory updates

 

S.N. Pharma employs a highly proficient staff that is well versed in all matters concerning the Medical Devices Directive of the Euopean Union including doctors, scientists, pharmacists and businessmen.