Services

STANDARD SERVICES

If you would like Mauritsz Business Coaching to act as your European Authorised Representative the following services are included in our standard monthly fee:
  • European Authorized Representative:
    A European appointed registered place of business within the EU acting as the legal identity of a non-EU manufacturer towards the EU Member State Competent Authorities and as a central European vigilance and contact point in the community
  • Pre-market notification (registration) of product(s) on behalf of a non-EU manufacturer, according to the specific EU regulation requirements the product(s) should comply with
  • Market incident reporting and complaint handling coordination
  • Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked product is properly put on the EU market.
  • Product labeling compliance


EXTRA SERVICES

As mentioned Mauritsz Business Coaching can perform more services related to the CE registration and their task as European Authorized Representative, such as:
  • Free sales certificates;
  • Certificate of CE registration (Related to products which require Notification)
  • Technical File documentation review
  • Guidance on QMS implementation
  • Guidance on product safety consultancy
  • Guidance on product testing and certification services
  • Device listing and registration according to EU member state national requirements

For more information about our services, prices and conditions do not hesitate to contact us.