The Obelis European Authorized Representative Center (O.E.A.R.C.) has been established in Brussels since 1988. Located at the heart of the EU, we provide European Authorized Representative (EC REP) and CE marking advisory services to manufacturers all over the world in accordance with European Directives and Regulations.
Backed by our ISO 9001:2008 & ISO 13485:2003 certification, our high quality compliance solutions include, but are by no means limited to, the following:
- Identification of EU standards
- Technical Documentation review
- Product Notification and Registration to national EU Authorities
- Labelling Compliance
- GMDN Code Verification
- Free Sales Certificates
- Trade Mark Submissions
With a unique expertise on medical devices and in-vitro diagnosis medical devices, our expert teams will assist you in introducing and/or maintaining the circulation of your product (s) within the EU market. Our consultants will guide you through the regulatory maze and various medical device directives to ensure access to the EU market for you and your devices.