GPSD 2001/95/EC Services
Obelis European Authorised Representative Center
Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices within the European territory. Our services are backed by 20 years experience giving regulatory, CE marking consulting, and European Authorized Representative services. We are located within a walking distance of the European Commission, maintaining close relations with the EU Administration.
European Authorized Representative Services
- European Authorized Representative: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
- Guidance on Self-Declaration release
- Market incident reporting and complaint handling coordination (GPSD 2001/95/EC)
- Product labeling compliance: European Authorized Representative address on the product related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (GPSD 2001/95/EC)
- Observance of the compliance of the non-EU manufacturer at all times, once the product is properly put on the European market
- Ongoing language maintenance and glossary development (for over 40 different languages)
- Device listing and registration according to European member state national requirements• Technical File documentation review
- Guidance on QMS implementation• Guidance on product safety consultancy
- Guidance on product testing and certification services
Services we can also provide
Free Sales Certificate services
For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.
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