TSD 88/378/EEC & 2009/48/EC Services

Authorized Representative tasks under Directive 2009/48/EC:
2009/48/EC Article 5.3;
“An authorized representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorized representative to do at least the following:

Keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of 10 years after the toy has been placed on the market;
Further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy;
Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.”

Obelis European Authorized Representative Center provides superior quality “European Authorized Representative”, notification, and regulatory services for the successful introduction of your medical devices, cosmetics and other products 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 Union;
Guidance on Self-Declaration release;
Market incident reporting and complaint handling coordination (TSD 88/378/EEC & 2009/48/EC);
Product labeling compliance: European Authorized Representative address on the toy related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (TSD 88/378/EEC & 2009/48/EC);
Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked toy 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