Obelis Group – EU Consultancy Services
Obelis is a quality driven, service oriented company, with over 25 years of experience in dealing with European directives and regulations. Obelis provides EU consultancy services to EU and non-EU manufacturers.
In 1996, the European Economic Community (EEC) declared that all non-European manufacturers must appoint an Authorized Representative or Responsible Person established within the European Community. Subsequently, Obelis s.a. launched the Obelis European Authorized Representative Center (O.E.A.R.C.) and the Obelis European Responsible Person Center (O.E.R.P.C.).
Today, as one of the largest regulatory centers in Europe, Obelis provides a wide range of CE marking services, including Authorized Representative services for medical devices and in-vitro diagnostics as well as EU Responsible Person services for cosmetics.
In addition, Obelis provides services for the majority of the NEW Approach European Directives which require either CE marking or an Authorized Representative. These directives include, but are not limited to:
- Personal Protective Equipment
- Pressure equipment
- Radio and telecommunication equipment
- Electrical equipment
Committed to the highest level of quality, Obelis is both ISO 9001:2008 and ISO 13485:2012 certified within the scope of its profession. Located at a walking distance from the EEC Headquarters, Obelis experts retain close contact with the EU administration. This allows manufacturers and collaborators to keep pace with the revisions of regulations, directives and other legislative acts within the EU legal framework.
Obelis is also an active member of a number of professional associations and EU commission committees. Some of our memberships include:
- Veteran member of the European Association of Authorized Representatives (E.A.A.R)
- Founding member of the European Responsible Person Association (E.R.P.A)
- Active member at the NB MED meetings for medical devices
- Active member of the EU Commission Medical Device Vigilance Committee
- Active member of the EU Commission IVD Technical Group
With a proven reputation in over 60 different countries around the globe, our work is supported by a strong network of international representatives called O.I.O. (Obelis International Offices).
In line with the belief that only a solid regulatory path will bring great ideas from the lab to the market, Obelis joined the European Horizon 2020 program for research and innovation. Under this program, Obelis fulfills the role of EU regulatory partner for projects with novel technologies.