Medical Custom Made 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;
- Guidance on Statement concerning Custom-Made devices;
- Market incident reporting and complaint handling coordination (MDD 93/42/EEC);
- Product labelling compliance: European Authorized Representative address on the device related printing materials i.e. catalogue, instruction sheets, packaging, manuals + verification of labelling 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.
- 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;
Contact us now to find out more.
View all Obelis Services