About us

Obelis, European Authorized Representatives Center (O.E.A.R.C.), operates as one of the largest regulatory centres in Europe today, providing CE marking advisory services & Authorized Representative services for Medical Devices, In-Vitro Diagnostics and other NEW Approach Directives (aimed at the CE marking) as well as “EU Responsible Person” aimed at Cosmetic services. With over 26 years of experience and while still retaining a special expertise in Medical Devices & Cosmetics, Obelis services cover most of the NEW Approach European Directives (Directives requiring either a CE marking or a nomination of authorized representative).

Committed to the highest level of quality services, since May, 2001, O.E.A.R.C. was certified according to ISO 9001:2008 with addition of ISO 13485:2012 certificate as of April 2012.

As members of the E.A.A.R (European Association of Authorized Representative) holding the treasury together with the secretary & ERPA (European Cosmetics Responsible Person Association) holding the chair, Obelis continues to be an active member in professional associations on a European level and participates in different committees at EU Commission level.

As of now Obelis gained experience as partner in FP7 and Horizon 2020 projects.