STANDARD SERVICESIf 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 SERVICESAs 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.