PED 97/23/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
Market incident reporting and complaint handling coordination (PED 97/23/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 (PE Directive 97/23/EC)
Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked product 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