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.