Legal Obligations

  • Informing Competent Authorities
    in the manufacturer's registered place of business the European Authorized Representative needs to notify the Competent Authorities about Class I medical devices, procedure packs, custom made devices and all IVD devices. 
  • Give national authorities insight in documentation
    the European representative needs to have certain documents like declarations of conformity and technical dossiers available if requested by the national authorities.

Qserve's EAR Service Package
including consultancy hours

Use of name and registered address within the EU on all product related labeling

Official appointed contact address for European regulatory agencies to comply with requirements

 

Review of a representative product file for compliance with European requirements

 

Vigilance reporting, technical representation, assistance and severity assessments

 

Notification of the Competent Authority regarding clinical investigation in the EU

Updates regarding regulatory changes which might impact devices and registrations

 

Want more information? Get in touch with us

Information request