Obelis European Responsible Person

Our Company

Obelis European Responsible Person Center (O.E.R.P.C.), is a quality driven, service oriented company with over 20 years of experience with European Directives & Regulations providing European Authorized Representative services and “EU Responsible Person” services aimed at Non-EU & EU Manufacturers.

Since early 1996, in response to the EEC mandatory requirement for non-European manufacturers to appoint an Authorized Representative established within the European Community, Obelis s.a. launched O.E.A.R.C.- Obelis European Authorized Representative Center which Obelis European Responsible Person Center (O.E.R.P.C.) is a part of.

Obelis operates as one of the largest regulatory centers 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.

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 authorized representative – such as medical devices, in-vitro diagnostics, machinery, personal protective equipment, pressure equipment, radio and telecommunication equipment, electrical equipment, low voltage equipments, toys and other consumer goods).

Committed to the highest level of quality services, since May, 2001, O.E.A.R.C. has obtained ISO 9001:2008 certification.

Located at a walking distance from the EEC Headquarters, Obelis retains close contact with the EU administration. Today, as one of the most important Authorized Representative Centers in Europe, Obelis provides its clients and collaborators with the direction of the EU Commission before hand.

Obelis is an active member in professional associations on a European level and present at EU Commission level in different committees:

-    Veteran member of E.A.A.R (European Association of Authorized Representative)

-    Founding member of E.R.PA. (European Responsible Person Association)

-    Active member at the NB MED meetings for medical devices

-    Active member at the EU Commission Medical Device Vigilance committee

-    Active member at the EU Commission IVD Technical Group

-    Active member at the EU Commission Cosmetic Annex I Committee

We maintain a proven international reputation among clients in over 40 countries around the world supported by our international network of Representatives called O.I.O. (Obelis International Offices).

Holding the most reliable team of regulatory experts in Europe today, the following services can be obtained through the Obelis European Authorized Representative Center:

   -  Classification of Products & Border Line products

   -  Identification of EU Standards

   -  Technical documentation review

   -  Authorized Representative (EC REP) covering 31 EEA countries

   -  EU “Responsible Person” covering 31 EEA countries

   -  Pre-Market Notification with the European Authorities

   -  Cosmetic Safety Toxicological Assessment support & guidance

   -  National Device Registration – ITALY / PORTUGAL

   -  Labeling Compliance & Translation (over 40 languages)

   -  GMDN codes

   -  FREE SALES CERTIFICATES

   -  International Representation (15 Global Markets)

   -  Trade Mark Submission

   -  Continuous consultancy & regulatory updates

Please feel free to contact us or post a query through our website for any additional information

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Over 20 Years of Success

Obelis European Authorized Representative Center (OEARC) based in Brussels, Belgium was founded by Mr. Gideon Elkayam in 1988. Obelis is one of the largest Regulatory Centers in Europe, assisting non-European medical device manufacturers' successful endeavors into Europe.

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ISO 9001:2008