obelis logo

Obelis European Authorized Representative Center

"CE Marking Consultants with a Reputation for Excellence"


You are here:
Obelis News:

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

 

  • 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
  • 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

    obelis people image

    Client Access

    Old system login



    New system login

    Search


    International Markets






    GiDoS - Green Regulatory Center

    Our sister company GiDoS s.p.r.l. provides REACH, WEEE, RoHS and P&PW compliance services.
    Visit GiDoS.net

    Newsletter

    » Sign up for our newsletter to receive our weekly publications on EU directives, our news and events, as well as updates to our web site.

    Follow us:

               

    Career Opportunities