AIMDD 90/385/EEC Services

Obelis European Authorized Representative Center provides superior quality representation, 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 ( AIMDD 90/385/EEC)
Product labeling compliance: European Authorized Representative address on the device related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labelling compliance ( AIMDD 90/385/EEC)
Notification of the preliminary Clinical Investigations (AIMDD 90/385/EEC Annex 6) following the procedure referred to in Annex 7
Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked device is properly put on the EEA.

Advisory services
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
Identification of proper regulation
Identification of EU harmonized standards
Post market surveillance assistance
Regulatory advice and updates

“Pre-CE marking” services
Identification of product classification
Identification of the appropriate notified body
Coordination between the manufacturer and the notified body

Additional services:
Free Sales Certificate services
Certificate of CE Registration (Related to products which require Notification)
GMDN code research services
For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.