MSD 2006/42/EC Services

Authorized Representative tasks under Directive 2006/42/EC:
“‘authorized representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive;” – MSD 2006/42/EC Article 2 (j);

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 ( MSD 2006/42/EC);
Product labeling compliance: European Authorized Representative address on the machinery related printing materials i.e. catalog, instruction sheets, packaging, manuals + verification of labeling compliance (MSD 2006/42/EC);

Observance of the compliance of the non-EU manufacturer at all times, once a duly CE marked machinery 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