MDD 93/42/EEC 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
• Market incident reporting and complaint handling coordination (MDD 93/42/EEC)
• Product labeling compliance: European Authorized Representative address on the device related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (MDD 93/42/EEC)
• Pre-market notification (registration) of devices on behalf of a non-EU manufacturer, according to the specific EU regulation requirements that the devices should comply with.
  • Notification of Class I devices (MDD 93/42/EEC Article 14)
  • A breakdown of the notification procedure of Class I devices is available here
  • Notification of the preliminary Clinical Investigations (Annex X) following the procedure referred to in Annex VIII
  • A breakdown of the notification procedure of Clincial Investigation is available here
• 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

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.

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