Obelis European Authorized Representatives Center (O.E.A.R.C.) is a quality-driven, service-oriented company with over 25 years of experience in European Directives & Regulations. We provide European Authorized Representative services and “EU Responsible Person” services aimed at both Non-EU and EU Manufacturers.
Additionally, Obelis operates as one of the largest regulatory centers in Europe today, offering CE marking advisory services and Authorized Representative services for Medical Devices, In-Vitro Diagnostics, and other New Approach Directives (aimed at CE marking), as well as “EU Responsible Person” services aimed at the cosmetics sector. While retaining special expertise in Medical Devices & Cosmetics, Obelis’ services cover most of the New Approach European Directives (Directives requiring either CE marking or an authorized representative).
Committed to the highest level of quality services, O.E.A.R.C. has been certified according to ISO 9001:2008 since May 2001, with the addition of the ISO 13485:2003 certificate in April 2012.
As one of the founding members of E.A.A.R. (European Association of Authorized Representatives) and ERPA (European Cosmetics Responsible Person Association), Obelis continues to be an active member in professional associations at the European level and participates in various committees at the EU Commission level.
Thanks to its proven expertise and reputation in the regulatory field, Obelis was invited by the University of Galway, Ireland, to join a consortium of five partners—one university and four SMEs, including Obelis—to work on an FP7 health-related project (NeuroGraft). Obelis is also a regulatory consultant partner in an H2020 project called GLAM (“Glass – Laser Multiplexed Biosensor”), coordinated by the Leitat Technological Center.
