Obelis s.a. (O.E.A.R.C.) now offers additional services beyond its required services as a European Authorized Representative. These additional services include, among many things, regulatory advice regarding the environmental directives, WEEE, RoHS, REACH and P&W. Along with these environmental directive services, Obelis provides regulatory advice and updates, post market surveillance assistance, device listing and registration according to EU member states national requirements, EU harmonized standards identification and a global network of regulatory, business and legal advisors: One Link:One Solution.
Obelis s.a. founded in 1988 has provided over 19 years of superior commercial, regulatory, administrative, and market development services to medical device manufacturers worldwide. As a member of the E.A.A.R. (European Association of Authorized Representatives), Obelis provides non-EU manufacturers with important E.A.R. services such as the primary identification of proper regulation and product classification. Obelis also serves as a legal identity designated within the EU, by the manufacturer, acting on behalf of the manufacturer as a central EU vigilance and contact point in the community. Obelis’ other E.A.R. services include, pre-market notification of products according to the specific EU regulation, market incident reporting and complaint handling coordination and observance of the compliance of the non EU manufacturer at all times. Obelis offers not only the identification of product classification for free, but also the identification of the appropriate notified body and coordination between the manufacturer and the notified body.
Furthermore, members of the European Association of Authorized Representatives (E.A.A.R.) provide services under the following European Directives: Medical Device Directive (MDD) 93/42/EEC, In-Vitro Diagnostic Directive (IVDD) 98/79/EC and Active Implantable Medical Devices Directive (AIMD) 90/385/EEC. In addition to these directives, Obelis covers the following directives: GPSD 2001/95/EC, COSMETIC 76/768/EEC, PPE 89/686/EEC, LVD 2006/95/EC, EMC 2004/108/EC, TSD 88/378/EEC, R&TTE 99/5/EC and MSD 98/37/EC.
Obelis (O.E.A.R.C.) currently serves as one of the largest and most important Authorized Representative centers in Europe and will be a fifth time exhibitor at Medica this year. Obelis continues to maintain and expand its services to provide its clients with efficient and customized solutions for their regulatory needs. Visit www.obelis.net to learn more.