Medical KITS Services

Obelis European Authorized Representative Center

Obelis European Authorized Representative Center (O.E.A.R.C.) provides 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 over 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;
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. catalogue, instruction sheets, packaging, manuals + verification of labeling compliance (MDD 93/42/EEC; AIMDD 90/385/EEC);
Pre-market notification of devices on behalf of a non-EU manufacturer, according to the specific EU regulation requirements that the devices should comply with.
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)
Technical File documentation review
Guidance on product safety consultancy
Identification of proper regulation
Identification of EU harmonized standards
Post market surveillance assistance
Regulatory advice and updates

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services;

View all Obelis Services