International markets attain EU Conformity through local domains

- Obelis brings the European market closer to your business -

Obelis European Authorized Representative Center (O.E.A.R.C.) objective, to support non-European manufacturers and other market players understand and as such achieve conformity with European Directives & Regulations, has always been a primary one, as only conformity shall provide access to the European Market. Such objective will be achieved only through education and providing admission to information in the most accessible manner. For that reason and in reference to Obelis’ ongoing commitment to education, dedicated explanatory and translated web pages have been launched by Obelis.

The explanatory web sites are operating under local domains. The main objective of these specific domains is to enable manufacturers and other industry players access to the relevant information through local search engines and most importantly, in their local language(s).

Each website offers an overview in the relevant language(s) on:

1. The European Regulations; primarily focusing on the MEDICAL DEVICE DIRECTIVE 93/42/EEC, IN-VITRO MEDICAL DEVICE DIRECTIVE 98/79/EC and the COSMETICS 76/768/EEC & EC 1223/2009 As well as other “New Approach Directives” requiring the CE Marking.
2. The role and responsibilities of a EUROPEAN AUTHORIZED REPRESENTATIVE (E.A.R.);
3. The SERVICES that should be provided by a professional E.A.R.

The below list will facilitate the ultimate intention: