IVDD 98/79/EC Services

Obelis European Authorized 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
• Pre-market notification (registration) of product(s) on behalf of a non-EU manufacturer, according to the IVDD 98/79/EC In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC, Annex III, 5)
• Market incident reporting and complaint handling coordination (IVDD 98/79/EC, Annex III, 5)
• Product labeling compliance: European Authorized Representative address on the device related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (IVDD 98/79/EC, Annex I, 8.4 (a))
• Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked device is properly put on the European market

Advisory services

Additionally, O.E.A.R.C. offers the following “pre-CE marking” services

• Identification of product classification
• Identification of the appropriate notified body
• Coordination between the manufacturer and the notified body

Services we can also provide

• 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.

Contact us now to find out more.

View all Obelis Services